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2020 SAN ANTONIO BREAST CANCER SYMPOSIUM SUMMARY

A summary of key announcements and breast cancer research presented at SABCS 2020.

SABCS 2020 Summary

The San Antonio Breast Cancer Symposium 2020 (SABCS 2020) is one of the most important breast cancer conferences in the world and brings together the world’s leading breast cancer researchers, including those from Breast Cancer Trials.

The conference is attended by a broad international audience of academic and private researchers and physicians from more than 90 countries. It aims to host a balance of clinical, translational and laboratory research, providing a forum for interaction, communication, and education for a broad spectrum of researchers and health professionals.

This year’s conference went virtual and saw a number of clinically significant results presented that will help to inform the treatment of breast cancer in the clinic and guide further clinical trials. We have provided a summary of important results presented at SABCS 2020 below:

Updated monarchE Data Shows That The CDK4/6 Inhibitor Abemaciclib Continues To Improve Invasive Disease-Free Survival Among Patients With High Risk, Node Positive, HR+ HER2- Breast Cancer

New data from the monarchE clinical trial shows that adding the cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib (Verzenio) to standard adjuvant endocrine therapy, continued to improve invasive disease-free survival among patients with high-risk, node-positive, early-stage, HR-positive (hormone receptor positive), HER2-negative (Human epidermal growth factor receptor 2) breast cancer.

The use of CDK4/6 inhibitors in breast cancer is increasing, with more clinical trials showing benefits from this emerging group of drugs. CDK4/6 inhibitors are a group of drugs that block proteins which stops certain processes involved in the ‘cell cycle’ that would otherwise cause cancer cells to grow and multiply.

These results are important as around 20 per cent of patients with HR positive breast cancer will be diagnosed with incurable metastatic breast cancer, either as their first diagnosis of breast cancer, or as a recurrence after early-stage breast cancer return. There is therefore a need to find new treatment options for these patients to prevent recurrence.

The new data from monarchE show that patients who received the CDK4/6 inhibitor abemaciclib (Verzenio) with adjuvant endocrine therapy, had a 28.7 per cent reduced risk of developing recurrent invasive disease compared to those who received endocrine therapy alone. The treatment had few additional side effects, and only 8% of patients stopped treatment due to those side effects. The researchers have said that more follow-up is required, however they are optimistic that these results could change how high recurrence-risk, HR positive, HER2 negative early breast cancer is treated.

Read more about these results here: 

Updated monarchE Trial Data Shows Abemaciclib Continues to Benefit Patients With High-risk, HR-positive, HER2-negative, Early-stage Breast Cancer

Some HR Positive Breast Cancer Patients Aged 65+ May Be Able To Avoid Radiation Therapy

10-year follow up of the PRIME II study has shown that patients aged 65 years or older could potentially safely avoid radiation therapy with no implications for their survival.

The clinical trial cohort were all aged 65 years or older and were diagnosed with HR positive breast cancer with low recurrence risk features after breast-conserving surgery. The trial compared patients who did not receive radiation therapy with those who did receive postoperative radiation therapy. All patients received endocrine therapy.

The study showed the rate of local recurrence (breast cancer returning), within the same breast, after 10 years was significantly higher in patients who did not receive radiation therapy compared with patients who did (9.8 per cent vs. 0.9 per cent). But while radiation therapy after surgery affected the risk of local recurrence, it did not have a significant impact on other relevant clinical outcomes.

After 10 years, patients who did not receive radiation therapy (vs those who did have radiation) had similar rates of distant metastasis (cancer which has spread from the breast) recurrence in the opposite breast, and overall survival (80.4 per cent vs. 81.0 per cent) as patients who did receive radiation therapy. Most deaths were due to reasons unrelated to breast cancer diagnosis or treatment.

The researchers involved in the study say that omitting postoperative radiation therapy did not compromise survival or increase the risk of distant metastasis. Based on their results, they believe that omitting radiation therapy after breast conserving surgery should be an option for older patients with localised, HR positive breast cancer who are receiving adjuvant hormone therapy and meet certain clinico-pathological criteria (low/intermediate grade, tumour size less than 3cm, axillary lymph node negative and surgical margins more than 1mm).

You can learn more about these results here:

Omitting Radiation Therapy After Breast-Conserving Surgery May Not Impact 10-year Survival Rates for Older Patients With HR-positive Breast Cancer

Breast Cancer Trials is undertaking its own clinical trial investigating if some women aged 50 years or older with HR positive, HER2 negative early breast cancer can safely avoid radiation therapy and its associated side effects.

The EXPERT clinical trial uses a genomic test, called PAM50 assay, to identify women who have a low risk of breast cancer recurrence and aims to therefore find out if these patients can safely omit radiation therapy.

Learn more about EXPERT here.

Long Term IBIS-II DCIS Follow Up: Anastrozole and Tamoxifen Both Prevent Breast Cancer In Postmenopausal Women

Long-term follow-up of the IBIS-II DCIS clinical trial has found that Anastrozole and Tamoxifen are both effective in preventing breast cancer and DCIS, providing more treatment options for postmenopausal women with pre-cancerous breast changes that could otherwise lead to breast cancer.

The results showed that the two drugs trialled in IBIS-II are similarly effective on preventing future DCIS or breast cancer over the 12 years of follow-up of the trial.

The IBIS-II DCIS trial aimed to find out if Tamoxifen or Anastrozole was better at preventing breast cancer or DCIS after prior surgical removal of DCIS in postmenopausal women. These two hormone blocking medications are effective in preventing breast cancer from returning, but the role in prevention after DCIS has been less clear. Tamoxifen is now available on the Pharmaceutical Benefits Scheme (PBS) as a preventative medication, but Anastrozole is not.

“An important part of the decision between Tamoxifen and Anastrozole is understanding the side effects, especially when taking them for preventative purposes,” said Breast Cancer Trials Medical Advisor and BCT Study Chair of IBIS-II Dr Nicholas Zdenkowski.

“This trial shows that both drugs are safe to take, with notable differences in the side effects. With

Tamoxifen, fewer fractures and strokes were seen. With Anastrozole, there was a lower rate of endometrial and ovarian cancer. This knowledge can assist with guiding patients towards which drug is more suitable for their personal circumstances. It is hoped that Anastrozole will be listed on the PBS for prevention purposes, given the favourable safety and effectiveness profile.”

2,980 women were recruited to the IBIS-II DCIS clinical trial worldwide, including 178 women at 24 institutions in Australia and New Zealand where the study was coordinated by Breast Cancer Trials.

Pregnancy After A Diagnosis Of Breast Cancer Appears Safe For Both Mothers And Babies

Women who have been diagnosed with breast cancer, and subsequently get pregnant, deliver healthy babies, and have no adverse effects on their long-term survival. Additionally, pregnancy after breast cancer was not associated with worse patient outcomes. Breast cancer patients who did get pregnant had a 44 percent reduced risk of death and a 27 percent reduced risk of disease recurrence compared with those who did not have a subsequent pregnancy.

This large meta-analysis of women diagnosed with breast cancer while at a childbearing age has shown that they are less likely than the general public to get pregnant and they face higher risk of complications such as preterm labour.

Compared with the general population, patients who had gone through a breast cancer diagnosis had a 60% reduced chance of having a pregnancy. The study showed that compared with women in the general population, women who had received a breast cancer diagnosis had a 50 per cent higher risk of having a baby with low birth weight; 16 percent higher risk of having a baby that was small for gestational age; 45 percent higher risk of preterm labour; and 14 percent higher risk of having a cesarean section.

This meta-analysis looked at 39 studies that identified women who became pregnant after their breast cancer diagnosis. The researchers looked at how many women had a pregnancy after their treatment, along with foetal and obstetrical outcomes, disease-free survival, and overall survival. In all, they looked at data on 114,573 breast cancer patients.

You can learn more about this research here:

Breast Cancer Survivors Are Less Likely to Get Pregnant, but Often Have Healthy Babies and Good Long-term Health

First Results Of Breast Cancer Trials PENELOPE-B Clinical Trial Presented

The first analysis of the phase three PENELOPE-B trial was presented at SABCS 20. Unfortunately, the results presented at SABCS 20 did not show a difference in disease free survival at almost four years follow-up.

PENELOPE-B is an international clinical trial for women who have received neoadjuvant chemotherapy for HR positive and HER2 negative breast cancer. Only women who had some cancer remaining in the surgically removed breast tissue were eligible, because this indicates a higher than average risk of cancer returning.

PENELOPE-B was investigating if adding one year of treatment with the drug palbociclib (a CDK 4/6 inhibitor) to standard hormone therapy would benefit this group of patients. 1250 patients were recruited worldwide, with 90 being recruited in Australia and New Zealand by Breast Cancer Trials sites.

The results showed the addition of one year of palbociclib to this patient group did initially delay invasive disease, but the difference disappeared with longer follow-up. At an average follow-up of 43 months (almost four years), no invasive-disease-free survival difference was seen between the palbociclib arm and endocrine therapy-alone arm.

This means that this clinical trial does not support adding one year of palbociclib to endocrine therapy in this patient population. The researchers involved in this study say that long term follow up from all adjuvant CDK 4/6 inhibitor, including PENELOPE-B, studies should continue, due to the potential for late recurrences in HR-positive breast cancer.

You can learn more about this research here:

SABCS 2020: Palbociclib Did Not Improve Disease-Free Survival in PENELOPE-B Trial

 

RxPONDER Study Shows Postmenopausal Patients With Node-Positive Breast Cancer And A Low Recurrence Score May Be Able To Avoid Chemotherapy

The RxPONDER trial evaluated the benefit of chemotherapy in women with early-stage, HR positive, node-positive breast cancer. Results presented at SABCS 2020 show that many of these postmenopausal women may be able to safely skip adjuvant chemotherapy.

These findings are similar to that of the Breast Cancer Trials TAILORx clinical trial, which also sought to identify subsets of patients with node-negative disease who fare well with endocrine therapy alone. Both TAILORx and RxPONDER used the Oncotype DX test.

RxPONDER found that women with early-stage HR positive, HER2 negative breast cancer with one to three positive axillary lymph nodes and a 21 – gene recurrence score (Oncotype DX*) of 25 or less did not benefit when chemotherapy was added to endocrine therapy. Therefore, these patients can safely avoid chemotherapy. However, pre-menopausal women in this patient group did benefit from adding chemotherapy to their treatment.

*The 21-gene recurrence score is available in Australia but is not publicly funded.

Other Breast Cancer Trials Results

  • Breast Cancer Trials researcher and Board Director, Professor Sherene Loi was awarded the prestigious AACR (American Association for Cancer Research) Outstanding Investigator Award for Breast Cancer Research. This award recognises a scientist whose novel and significant work has had or may have a far-reaching impact on the etiology, detection, diagnosis, treatment, or prevention of breast cancer. You can read more about Professor Loi’s AACR award lecture on using genomics to better understand the breast cancer microenvironment here.
  •  The PALLAS clinical trial results were presented in a poster session at SABCS 2020. The poster session at a conference allows researchers to present their results to all conference attendees. The PALLAS poster presentation showed that persistence with palbociclib for the full two years of protocol defined therapy did not improve disease free survival compared with those who stopped treatment early for any reason. You can learn more about recent PALLAS results here.
  • Results from the ALTTO trial were presented at SABCS 2020. ALTTO was an international phase III clinical trial of two targeted therapies for HER2-positive breast cancer. HER2 is expressed at high levels in up to 20 percent of all breast cancers. Tumors that overproduce HER2 are generally more aggressive and more likely to recur than those that do not. This adverse prognosis is improved substantially with trastuzumab. The medications being tested in ALTTO, lapatinib (Tykerb®) and trastuzumab (Herceptin®), target HER2 in different ways. Researchers sought to find out whether one drug is better than the other at helping women live longer without a recurrence of their disease, or if the two drugs work better together. The analysis presented at SABCS found that patients who experienced cancer relapse before 12 months from completion of adjuvant trastuzumab had worse survival compared with those whose cancer relapsed after the 12-month mark. Researchers say given its prognostic value, treatment free interval can help to individualize clinical recommendations and to design future trials in the metastatic setting for patients relapsing after prior exposure to anti-HER2 therapy for early disease.
  • Results from the APHINITY clinical trial were presented in a poster spotlight discussion. With 45 months follow up, a trend towards greater benefit from adjuvant pertuzumab was seen in patients with HER2 positive breast cancer with a single activating HER2 pathway compared with those with multiple cancer activating pathways. Researchers say that with further research, this trend could offer HER2+ breast cancer patients and their doctors information at the beginning of their journeys that could help them define the path ahead.

Other SABCS 2020 News

  •  In the final analysis of the SOLAR-1 clinical trial, biomarker analysis showed that patients with circulating tumour DNA had superior progression free survival with alpelisib and fulvestrant vs placebo and fulvestrant (11 vs 3.6m). This provides further rationale for the Breast Cancer Trials CAPTURE trial.
  •  Results from the BYLIEVE study presented showed patients whose cancer had progressed on fulvestrant and CDK4/6i, and who had a tumour PIK3CA mutation, were given letrozole with alpelisib. The study met its primary endpoint, with 46% of patients alive without progressive disease at 6 months.
  • An interesting debate took place at SABCS, on whether all breast cancer patients should receive genetic testing for an inherited predisposition to breast cancer. Two expert clinical scientists discussed the benefits and the potential drawbacks of universal genetic testing. You can read more about the pros and cons presented at this virtual debate here.
  • Mary-Claire King, PhD, who linked the BRCA1 gene mutations with breast and ovarian cancers in the early 1990s, presented a lecture calling for universal genetic testing for BRCA1/2 gene mutations. This may be of interest to anyone interested in our BRCA-P clinical trial. Read more about her lecture here.

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FIRST AUSTRALIAN BRCA-P TRIAL PARTICIPANTS

Cousin’s Raelee and Lisa are the first Australian participants in the ground-breaking BRCA-P clinical trial, which is testing the effectiveness of a drug called Denosumab in preventing breast cancer in women with a BRCA1 gene mutation.

Meet The Cousins Helping To Prevent Breast Cancer For Women With A BRCA1 Gene Mutation

Cousins Raelee and Lisa have the BRCA1 gene mutation.

It’s an inherited gene that significantly increases their chances of being diagnosed with breast cancer.

Their parents cousin had been diagnosed with breast cancer and discovered she carried the  BRCA1 gene mutation. This led to Lisa’s and Raelee parents being tested and discovering they also carried the gene.

This was significant, as children of women and men with a confirmed BRCA1 gene mutation have a 50/50 chance of inheriting it.

Lisa said after other family members had tested positive to the genetic mutation, her dad was contacted and asked if he would like to undergo genetic testing.

“I think initially he wasn’t that interested in being tested,” Lisa said. “But once I explained to him that that’s how you find out whether you have the genetic mutation and then, if he was positive, we could find out whether I have the gene, that it was important to me. Then he was very keen to have the testing.”

After Lisa’s dad found out he had the genetic mutation, Raelee mother underwent testing. When it was confirmed she also had inherited the mutation, Raylee underwent her own genetic test.

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Cousin’s Raelee and Lisa are the first Australian participants in the ground-breaking BRCA-P clinical trial.

What Is The BRCA1 Gene Mutation?

Both Raelee and Lisa were unawares of how the positive test would impact their lives.

“I thought it mainly meant breast cancer. I didn’t realise it also meant ovarian cancer, and I didn’t realise that it could possibly affect men as well,” said Raylee.

Everyone has BRCA1 and BRCA2 genes. The function of the BRCA genes is to repair DNA damage in a cell and keep breast, ovarian, and other cells growing normally. An inherited mutation in a BRCA1 or BRCA2 gene means that one of the copies of the gene is not working but that the other copy can maintain the normal function.

It is when the second copy of the BRCA1 or BRCA2 gene acquires a mutation that both copies are now non-functional, and the wrong protein is made.

With two non-functional copies making the wrong protein, the ability of the cell to repair DNA damage is affected. If DNA damage cannot be repaired, but the cell remains alive, the cell may become cancerous by growing uncontrollably and forming a tumour mass.

BRCA1 and BRCA2 gene mutations account for about 5-10% of breast cancer diagnoses in Australia today.

But the Breast Cancer Trials BRCA-P clinical trial hopes to change that.

Participating In The BRCA-P Clinical Trial

The BRCA-P clinical trial is a prevention trial which is testing the effectiveness of a drug called Denosumab in preventing breast cancer in women with a BRCA1 gene mutation, like Lisa and Raelee. This treatment has been fast-tracked from the lab to a stage three clinical trial due to its impressive pre-clinical results.

It is a welcome prevention alternative for Lisa and Raelee.

The cousins were seeing the same specialist for breast cancer screening and to discuss their options. She raised the BRCA-P trial with them both in a regular screening appointment and both women were immediately interested.

Their children were front of mind when they made their decision to participate.

“I said yes because my initial thought was how could this affect my family in the future? Could this possibly be a way for my kids to have a better outcome if they test positive to this gene mutation.”

Raelee – BRCA-P Clinical Trial Participant
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Lisa agreed, sharing that the 50/50 chance of her children inheriting the gene mutation is why she wanted to participate.

“I think about it all the time.”

“What if they do have the gene and what if that means that they may develop breast cancer and what decisions are they going to make in the future? And how is that going to affect their life? It’s definitely a concern.”

Both women said despite not having a great understanding of clinical trials before-hand, they were confident in participating.

“My knowledge of clinical trials was from Grey’s Anatomy,” said Raelee.

However, her specialist explained the purpose and requirements of the trial to them so they could understand fully what they were agreeing to and give their informed consent.

“She explained how you needed to commit to the full programme, the five years.”

“They said, obviously things do change, and things come up, but you needed to be able to commit and follow it through so that they get true results.”

“They explained everything really well. They gave us lots of information. It’s very straightforward.”

The Benefits Of Participating In The BRCA-P Clinical Trial

The BRCA-P clinical trial is a randomised, double-blind, placebo-controlled study meaning that participants will be randomly allocated to receive either the trial drug or a placebo and neither the participant nor their doctor will know who is on the study drug and who is not. This is to ensure the trial results and reporting will be unaffected by any potential bias.

So Lisa and Raelee do not know if they are receiving the trial drug or placebo. But even If they are not receiving the trial drug, they have already seen benefits of participating.

The trial requires women to see their clinical trial team twice a year to receive an injection and undergo monitoring and screening.

“While we were already undergoing screening anyway with our specialist due to our BRCA status, but this is another added layer of screening. I can also bring up any questions or concerns in the appointments,” said Lisa.

“We’re getting an additional check every year with a specialist. So all of that is great. It’s all very positive and I think that if anything did happen to us, the clinical trial team would be on top of it right away.”

Lisa – BRCA-P Clinical Trial Participant
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“I’ve just had my second appointment, and it was really quick,” said Raelee. “We went and had blood tests. I had a quick chat with the doctor, and I was given a second injection.”

Looking To The Future When You Have A BRCA1 Gene Mutation

Both women are participating in the BRCA-P clinical trial to ensure they have a future for themselves, and also for their family.

Both have children and have had to grapple with the fact that they may have passed down this genetic mutation to them.

Raelee said her daughter is now just beginning to come to terms with what it could mean for her.

“I was pretty open from the start with my kids. They were a little bit older than Lisa’s when I found out I had the mutation.”

“My daughter didn’t want to know anything at the time. She would say, ‘This is not happening. We’re not getting this. Go away. Don’t talk to me about it.’”

“But now she’s in her 20’s and she’s definitely more interested in finding out how to be proactive about it.”

Lisa’s children are younger, and don’t yet fully understand how this could affect them.

“I think about how I’m going to talk to them about it,” she said. “I think you have to be very careful in how you talk about it, because the decisions that they have to make can affect their life in a very big way.”

But both women are hopeful and positive that their participation in the BRCA-P clinical trial will bring real change to their children and many other women and men who carry the BRCA1 gene mutation.

“I hope that this trial is successful, and that if my kids do test positive eventually, they’ll have access to this treatment to hopefully break that chain off genetic mutation.”

Raelee – Clinical Trial Participant
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How You Can Participate In The BRCA-P Clinical Trial

The BRCA-P clinical trial is a prevention clinical trial, therefore potential participants are those who have not had breast cancer but who carry the BRCA1 gene mutation and therefore are at higher risk.

Eligibility must be assessed carefully and includes the following criteria:
o Women who carry a BRCA1 gene mutation and are aged 25-55 years and unaffected by breast or ovarian cancer.

  • May be either pre or post-menopausal.
  • Not pregnant or planning to get pregnant.
  • Have not had preventative breast surgery.
  • Not taking any breast cancer preventative agents such as Tamoxifen or an Aromatase Inhibitor.

If you believe you are eligible and would like to participate in this very important research, your genetic counsellor or familiar cancer centre can provide a referral to a participating institution.

The BRCA-P clinical trial will be open by Breast Cancer Trials in 15 medical institutions throughout Australia.

You can sign up to receive updates on the trial, including when each site opens, here.

The trial will open at:

  • The Olivia Newton John Cancer Wellness and Research Centre (Austin Hospital)
  • Ballarat Oncology and Haematology Services
  • Concord Repatriation General Hospital
  • Lake Macquarie Private Hospital
  • Monash Medical Centre (Clayton)
  • Prince of Wales Hospital
  • Royal Adelaide Hospital
  • Royal Brisbane and Women’s Hospital
  • Royal Hobart Hospital
  • The Royal Melbourne Hospital
  • Royal North Shore Hospital
  • St John of God Hospital Subiaco
  • St Vincent’s Hospital Sydney
  • Westmead Hospital
  • Wollongong Hospital

If you are unable to participate, but would still like to support this research, you can show your support by donating below.

 

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QUICK ACCESS

Meet The Cousins Helping To Prevent Breast Cancer For Women With A BRCA1 Gene Mutation

What Is The BRCA1 Gene Mutation?

Participating In The BRCA-P Clinical Trial

The Benefits Of Participating In The BRCA-P Clinical Trial

Looking To The Future When You Have A BRCA1 Gene Mutation

How You Can Participate In The BRCA-P Clinical Trial

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IMPROVING TREATMENTS FOR TRIPLE NEGATIVE BREAST CANCER

A summary of multiple clinical trials has helped to develop tools to predict the recurrence of breast cancer.

IBCSG VIII and IX Clinical Trial DNA Follow Up

Researchers are improving and refining breast cancer treatments by delving into the DNA of patients who have previously volunteered for breast cancer clinical trials.

“We already have the ability to distinguish between different levels of ‘severity’ of breast cancer, but we need to develop this further,” says Dr Nicholas Zdenkowski, Medical Advisor at Breast Cancer Trials.

While breast cancer treatments can already be targeted and personalised, Dr Zdenkowski says new and highly accurate tools could help determine which triple negative breast cancer patients can be cured with surgery alone. Triple negative breast cancer accounts for 15 per cent of all breast cancers.

“The standard approach is to offer women with the triple negative subtype of early stage breast cancer a fairly intensive treatment with chemotherapy, because there are no sufficiently accurate tests to determine which patients definitely don’t need any further treatment beyond surgery,” he says.

“Many patients worry that triple negative breast cancer has a worse prognosis than other breast cancer types, however, this is not always the case.”

Breast Cancer Trials provided data from previous trials called IBCSG VIII and IX, which had enrolled 228 and 330 patients respectively, towards the development of molecular tools to predict the recurrence of breast cancer after chemotherapy treatment.

The lab-based analysis looked at specific DNA methylation markers, or profiles, in the genes of breast cancers that had been surgically removed from patients. The study was centred around blood and tumour specimens held from clinical trials between 1985 and 2009.

The methylation markers helped categorise the early-stage triple negative patients into three groups: those who were cured with surgery to remove the cancer and so didn’t need further treatment; those who needed chemotherapy to prevent the cancer from returning after treatment; and those for whom chemotherapy was not effective, where the cancer came back elsewhere in their body despite that treatment.

However, Dr Zdenkowski says this test method needs further research before it can be considered for routine use in the clinic.

“As with any new test or treatment, the method requires rigorous evaluation to ensure it does what it promises to,” he says.

The use of well-collected and ‘clean’ clinical trial data in this way also illustrates the value in continuing to study and learn from patients who volunteered for previous trials.

“Ultimately, from this research, we hope to be able to reassure some patients that they can be cured with surgery alone,” Dr Zdenkowski says.

“We can also reassure others they will be cured with chemotherapy.”

“The third group, whose cancer will return even with surgery and chemotherapy, is the group in need of better treatments that we hope to find through ongoing research – so we can give them the best chance of being cured of cancer.”

Publication:

DNA methylation markers predict recurrence-free interval in triple-negative breast cancer.
Fackler MJ, Cho S, Cope L, Gabrielson E, Visvanathan K, Wilsbach K, Meir-Levi D, Lynch C.F., Marks J, Geradts J, Regan MM, Viale G, Wolff AC, Sukumar S, Umbricht CB. npj Breast Cancer 2020; 6Article No. 3;, https://doi.org/10.1038/s41523-020-0145-3.

 

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Dr Nicholas Zdenkowski

Dr Nicholas Zdenkowski is the Medical Advisor at Breast Cancer Trials, a BCT researcher and medical oncologist.

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CHEMOTHERAPY RISKS AND BENEFITS ACCORDING TO BODY MASS INDEX

Researchers have reanalysed data from the BIG 2-98 clinical trial and the relationship between anti-cancer drugs and BMI.

Chemotherapy and BMI: BIG 2-98 Clinical Trial Follow-Up

The role of obesity as a risk factor is a common theme in breast cancer research. That’s not about to change anytime soon.

“In Western society there are more and more women who are overweight and, because being overweight increases your risk of getting breast cancer after menopause, we certainly see this in our clinic,” says Associate Professor Prue Francis, Chair of the Breast Cancer Trials Scientific Advisory Committee.

Some lipophilic, or fat-soluble, drugs are known to act differently in someone who has a high versus a low body mass index (BMI). What hasn’t been studied systematically is the relationship between the efficacy of anticancer drugs and BMI.

To learn more, researchers reanalysed data from the BIG 2-98 trial that included approximately 600 women enrolled by Breast Cancer Trials, some of whom were randomised to receive the lipophilic chemotherapy drug docetaxel as part of treatment.

They found that among the women who received docetaxel, those in the overweight or obese BMI categories had a lower chance of remaining disease-free or surviving compared to women with a lean BMI, despite receiving the same treatment.

“If you’re giving any drug that might have short-term but also longer-term side effects, the question is, are you getting the bang for your buck?” says Associate Professor Francis, who was one of the researchers in the study.

Docetaxel and other drugs of the same family (taxanes) can cause nerve damage, and occasionally permanent hair loss. The risk of experiencing such side effects must be balanced with the benefit an individual patient might receive.

Associate Professor Francis says that chemotherapy for obese patients should not change based on these results, but more research is needed. If the results of this study are confirmed in other studies, this could lead to a rethinking of treatment risks and benefits for these patients.

“If the taxane drugs were thought not to be working or distributed properly in the body of obese patients [we could consider] whether a modification of the dose would be appropriate or whether it’s just not worth adding those drugs,” she explains.

“If an obese patient may not be deriving so much benefit from that particular drug, maybe you could give a different drug, or stop it earlier if nerve damage symptoms are developing.”

Publication:

Differential benefit of adjuvant docetaxel-based chemotherapy in patients with early breast cancer according to baseline body mass index.
Desmedt C, Fornili M, Clatot F, Demicheli R, De Bortoli D, Di Leo A, Viale G, de Azambuja E, Crown J, Francis PA, Sotiriou C, Piccart M, Biganzoli E. Journal of Clinical Oncology. 2020; 38(25):2883-2891, epub 20/05/20 https://doi.org/10.1200/JCO.19.01771.

 

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Professor Prue Francis

Breast Cancer Trials Researcher and Clinical Head of Breast Medical Oncology at the Peter MacCallum Cancer Centre.

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PREDICTING SEXUAL DIFFICULTIES IN PREMENOPAUSAL WOMEN

How clinicians can assist patients in managing a treatment side effect of sexual difficulties.

SOFT/TEXT Clinical Trial Follow-Up

Among premenopausal women with breast cancer, 80% have hormone-responsive breast cancer, where the hormone oestrogen can stimulate the growth of cancer cells.

To stop this from happening after the primary cancer has been removed, women may be treated with one or more drugs that either prevent the uptake of oestrogen by cells (oestrogen blockers like tamoxifen), switch off the production of oestrogen in the ovaries (ovarian function suppression), or block oestrogen production in body fat (aromatase inhibitors).

The SOFT and TEXT clinical trials investigated the effects of different treatment combinations in premenopausal women on survival and recurrence of cancer. Researchers also collected and analysed information about a common and distressing side effect of such treatments: sexual problems including low libido and difficulty becoming aroused.

The impact of treatment on sexual function can be so important for quality of life that it can affect adherence to treatment, says Associate Professor Prue Francis, Chair of the International Steering Committee responsible for the SOFT and TEXT clinical trials.

“Sometimes women just don’t want to take their treatment at all because they’re having problems and they just stop,” says Associate Professor Francis.

The researchers wanted to identify factors that, if present six months into the five-year treatment, predict whether a premenopausal woman will experience sexual difficulties later.

They found that women who reported vaginal dryness, sleep disturbance and bone or joint pain at the six-month mark were more likely to report sexual problems in the first two years.

Recognising these predictors in their patients may guide clinicians to ask about sexual problems, which patients may not otherwise bring up. These conversations might equip clinicians to take a more nuanced and individualised approach to treatment, she says.

Take, for example, a woman experiencing significant side effects from treatment with both aromatase inhibitor and ovarian suppression therapy. Clinicians might consider “the absolute benefit that they’re likely to obtain from having that more intense endocrine therapy,” says Associate Professor Francis.

“Should they really be encouraged to persevere because they have a very high-risk breast cancer and therefore they’re likely to derive more of a differential benefit from that maximal endocrine therapy? Or might their breast cancer not be at such high risk for recurrence, and perhaps it would be reasonable then to dial back to a less intense endocrine approach?”

Publication:

Treatment-induced symptoms, depression and age as predictors of sexual problems in premenopausal women with early breast cancer receiving adjuvant endocrine therapy.

Ribi K, Luo W, Walley BA, Burstein HJ, Chirgwin J, Ansari RH, Salim M, van der Westhuizen A, Abdi E, Francis PA, Chia S, Harvey VJ, Giobbie-Hurder A, Fleming GF, Pagani O, Di Leo A, Colleoni M, Gelber RD, Goldhirsch A, Coates AS, Regan MM, Bernhard J. Breast Cancer Research and Treatment. 2020; 181(2):347-359, epub 09/04/20 doi.org/10.1007/s10549-020-05622-5.

 

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Professor Prue Francis

Breast Cancer Trials Researcher and Clinical Head of Breast Medical Oncology at the Peter MacCallum Cancer Centre.

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NEW HOPE FOR STAGE 4 BREAST CANCER PATIENTS

The SEGMENT study examined the feasibility of characterising genomic alterations using gene sequencing on tumour specimens from patients with breast cancer.

The SEGMENT Study

Metastatic (stage 4) breast cancer is incurable, but a new study suggests that genomic profiling could lead to better treatment options for patients.

The SEGMENT study examined the feasibility of characterising genomic alterations using gene sequencing on tumour specimens from patients with breast cancer.

The study found that genomic sequencing for the management of metastatic breast cancer is both feasible and has implications for clinical practice, particularly for patients who are able to participate in clinical trials of newer treatments.

The project, which was spearheaded by Professor Sherene Loi at the Peter MacCallum Cancer Centre, received funding from Breast Cancer Trials.

“Patients with metastatic breast cancer are looking for anything that can give them hope,” says medical oncologist Dr Peter Savas, Dr Loi’s colleague at the Peter MacCallum Cancer Centre. “SEGMENT was about trying to use what was at the time quite a new technology, and bring it into the clinic to see if we could use that to give patients more options.”

The development of Herceptin – a drug that targets overactivity of the HER-2 gene in one of the more aggressive types of breast cancer – in the 1990s, opened the door to better-targeted therapies.

“Now, the prognosis of that cancer is significantly better,” Dr Savas says. “That’s a really good example of the proof of principle that tailoring treatments to specific features in the cancer can be very fruitful. The next logical question is, can we take that approach and make it more broadly applicable to patients with metastatic breast cancer?”

Meanwhile, sequencing technologies – relatively rare when SEGMENT began in 2013 – have become cheaper and more accurate, making profiling of metastatic breast cancer more available.

One barrier to that, Dr Savas says, is a lack of awareness among oncologists and patients. “But that’s improving over time, and the pairing of genomic findings with treatments will become more widespread.”

Launched in 2019, the drug alpelisib is one example of this. It specifically targets the PIK3CA mutation, which is common in many patients with hormone receptor positive breast cancer, Dr Savas says. “Following that, there’s a long tail of rarer alterations,” he adds.

“SEGMENT is a big study, but it doesn’t have enough patients to understand the importance of rarer alterations. But by putting it together with other datasets, we can get a better idea of the changes and their significance.”

 

Publication:

Clinical implications of prospective genomic profiling of metastatic breast cancer patients.
van Geelen CT, Savas P, Teo ZL, Luen SJ, Weng C-F, Ko Y-A, Kuykhoven KS, Caramia F, Salgado R, Francis PA, Dawson S-J, Fox SB, Fellowes A, Loi S. Breast Cancer Research. 2020; 22:91:https://doi.org/10.1186/s13058-020-01328-0.

 

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Professor Sherene Loi

Professor Sherene Loi is a Breast Cancer Trials researcher and board director, consultant medical oncologist, clinician scientist, head of the Translational Breast Cancer Genomics and Therapeutics laboratory at the Peter McCallum Cancer Centre and Co-Chair of the IBCSG.

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PREVENTING THE SIDE EFFECTS OF PREVENTATIVE TREATMENT

A follow up on the IBIS-II clinical trial has evaluated the side effects of the breast cancer preventative agent Anastrozole and how they can be managed.

Preventing The Side Effects Of Preventative Treatment

The saying ‘prevention is better than a cure’ is especially apparent when it comes to disease. But, while breast cancer prevention remains crucial, the side effects of individual treatment plans also need to be considered.

Anastrozole is a drug that is used to either prevent or control breast cancer. It’s a tablet that works by blocking the body’s production of oestrogen in postmenopausal women. It’s taken to prevent cancer recurrence, or control cancer that has spread to other parts of the body. It also reduces the chance of breast cancer in women with a higher risk of developing the disease by 50 per cent.

“So, why don’t we just give this drug to all women? Because of its potential side effects,” says Dr Nicholas Zdenkowski, Medical Advisor at Breast Cancer Trials.

He says a relatively common effect is one that would likely go unnoticed initially: bone density loss.

“This won’t be obvious until you end up with a bone fracture or see a decline in bone density on a scan,” he says.

Dr Zdenkowski was the Australian clinical lead on an international study to see if the drug risedronate could prevent anastrozole-induced bone loss.

The trial was co-led by Breast Cancer Trials and was a sub-study of the 4,000 post-menopausal high-risk patients already on the IBIS-II clinical trial that showed that anastrozole could prevent breast cancer.

This bone sub-study involved 258 of the 1,410 patients (229 from Australia and New Zealand) who enrolled in the bone study within IBIS-II. It found risedronate did indeed slow down anastrozole-induced bone loss – but couldn’t completely prevent it. While the drug stabilised loss in the lumbar spine, the hip still deteriorated.

“The options for breast cancer prevention include anastrozole, exemestane and tamoxifen, but they all come with their own set of potential side effects,” Dr Zdenkowski says.

“While bone density is something that naturally declines slowly over time, unfortunately anastrozole adds to that decline.”

He says more options are needed for patients on breast cancer prevention drugs.

Dr Zdenkowski suggests patients have their bone density monitored regularly so that osteoporotic changes are identified and treated accordingly, before the stage where they are at significantly higher risk of hip or spine fractures.

He said overall, the lessons learned from the risedronate trials tie into important decisions around preventative treatment plans. This includes, for patients with a high risk of breast cancer combined with a high risk of bone loss, whether to put them onto alternative treatments to counter the development of osteoporosis.

“There is obviously more work to be done on the prevention of breast cancer,” Dr Zdenkowski says. “The more we know, the more this helps with clinical decisions around the risk vs benefit of treatment recommendations.”

Publication:

Comparison of risedronate versus placebo in preventing anastrozole-induced bone loss in women at high risk of developing breast cancer with osteopenia. Sestak I, Blake GM, Patel R, Colemen RE, Cuzick J, Eastell R. Bone. 2019; 124:83-88, https://doi.org/10.1016/j.bone.2019.04.016.

 

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Dr Nicholas Zdenkowski

Dr Nicholas Zdenkowski is the Medical Advisor at Breast Cancer Trials, a BCT researcher and medical oncologist.

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BENEFITS OF EXERCISE FOR BREAST CANCER PATIENTS

We speak with Professor Erica James about the benefit of exercise for breast cancer patients, how lifestyle changes can help to reduce the risk of recurrence and the best ways to get active after a diagnosis.

IS it OK To Exercise With Breast Cancer?

More than 40% of new cancer cases are linked to lifestyle factors, and about one third of all cancers are preventable through a healthy diet, being physically active and maintaining a healthy weight.

The link between good health and exercise is well established and more cancer practitioners are prescribing exercise as part of treatment plans for their patients.

But with treatment comes many different side effects and physical changes that can make the idea of getting out for a run or hitting up a body pump class incredibly undesirable.

However, even small lifestyle changes during and after treatment can reduce the side effects of treatment, improve quality of life, and reduce the risk of breast cancer returning.

Exercise scientist and behavioural epidemiologist at the University of Newcastle and the Hunter Medical Research Institute (HMRI), Professor Erica James, said the side effects of treatment can be, at times, debilitating for patients, but it’s important at this time to engage in healthy behaviours that will aid in recovery.

“I have had patients tell me they have been tired before, they have had small children, done shift work, had interrupted sleep. They thought they knew what it felt like to be tired. But this (cancer related fatigue), it’s a whole new world.”

Professor Erica James – Behavioural Epidemiologist
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Professor James acknowledges that it can feel counter-intuitive to move rather than rest at this time, but, creating good sleep habits and incorporating movement into the day, will help to improve quality of life and increase your energy throughout the day.

She said that being active and having good sleep hygiene is important. This means avoiding naps during the day, avoiding caffeine after lunchtime, and having a regular bedtime routine.

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We speak with exercise scientist and behavioural epidemiologist Professor Erica James, about the benefit of exercise during and after a diagnosis, how lifestyle changes can help to reduce the risk of breast cancer recurrence, and the best ways to get active after a diagnosis.

So how much should you be exercising?

Professor James said that the exercise and movement recommendations for those who have received a breast cancer diagnosis are similar to that of the general population. 150 minutes of moderate to vigorous activity a week, or at least 30 minutes of movement on at least five days of the week, is recommended, as well as two or three strength-based activities.

However, each individual will be different.

“Whenever there’s been a major medical issue like a cancer diagnosis, it’s really important that the exercise prescription can be tailored to the person’s individual circumstances,” said Professor James.

This is where expert advice can be really helpful.

In Australia, the organisation that looks after exercise prescription is called ESSA (Exercise and Sports Science Australia). This professional organisation accredits exercise physiologists and ensure they can safely prescribe a personalised exercise plan for those who have chronic diseases like cancer.

You can use the ESSA website to find an accredited exercise professional that can help you get moving safely.

You can enter your postcode and special interest area (for example, cancer) and find someone suitable close to you.

Professor James also acknowledges that this can be an expensive endeavour in an incredibly tough financial time of a person’s life. She said that, in this case, a patient should approach their GP about getting Medicare subsidised assistance.

“In Australia, we have a fantastic system that’s Medicare funded, called a chronic disease management plan.”

“You can go to your GP and say I want to see an exercise physiologist.”

“They write you a chronic disease management plan and you get up to five Medicare subsidized visits with an exercise physiologist in a 12-month period.”

Professor James said in these subsidised visits, you can get an assessment, get taught how to do the exercises safely and have a tailored, personalized plan written just for you.

How can I start moving?

Professor James said that it’s important that you enjoy the exercise you undertake.

“So if you start a walking program, are there great podcasts that you love to listen to?”

“We also know that people who own dogs are more active. They’re more motivated to still get out and walk even if the weather is bad or they are feeling tired.”

“Reflect on where you have had success before. What can I integrate into my lifestyle that’s likely to be able to be maintained?”

Professor Erica James – Behavioural Epidemiologist
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She also said that starting small is the best first step and that any movement is better than no movement at all.

“It’s certainly not about jumping straight into a seven day a week high intensity exercise program.”

She recommends starting by reframing what exercise is in your mind and weaving exercise into your everyday life. For example, instead of trying to get the closest car park you can, park a little away from your destination and make the most of the walk. Setting goals, making a plan, and getting your friends and family on board are important strategies to ensure you can maintain activity in the long term.

What questions should I ask before exercising?

Before you begin your exercise treatment plan, you should discuss your physical capabilities with your treatment team.

“Some key questions that you might want talk to your doctor about is clarifying whether you have an increased risk of bone fracture.”

“If you’ve got low bone mineral density, if you’re postmenopausal, if you’re older, or if the cancer has spread to your bones, then you might be at an increased risk of breaking a bone if you were to have a fall.”

“In those cases, we would recommend lower impact exercises like walking, swimming or yoga, and modifications if balance is an issue, such as chair-based exercises.”

“If you’re having active treatment, another question to ask your treatment team would be, am I at increased risk of infection?”

“If, for example, you’re undergoing chemotherapy and you’ve got a reduced white cell count, but you want to go swimming in the local pool, it would be helpful to clarify your current risk and make a plan around that.”

Professor James strongly recommends those with a cancer diagnosis visit an accredited exercise physiologist to ensure they are moving appropriately for their situation.

However, if a patient would prefer to see a personal trainer, or engage in group fitness, she encourages them to ask if they have experience training someone with a cancer diagnosis. If they are willing to provide modifications to exercises that are appropriate to your individual situation and if they have any qualifications to train someone in your situation.

Can these changes help reduce my risk of cancer returning?

Professor James said these lifestyle changes can be incredibly helpful in maintaining a good quality of life throughout and post treatment, as well as helping to maintain good mental health and reduce the effects of treatment side effects.

She also said that exercise has a significant impact on helping to reduce the risk of breast cancer returning and the risk of death from breast cancer.

A review of the effect of lifestyle factors on breast cancer mortality found that physical activity is consistently linked to a lower risk of breast cancer recurrence.

A large study showed that women who exercised moderately (the equivalent of walking three to five hours a week at an average pace) following a breast cancer diagnosis had 40% to 50% lower risks of breast cancer recurrence and death from breast cancer or any cause, compared with women who exercised less.

The benefit of exercise was particularly apparent in women with hormone-responsive breast tumors.

So although it may seem like the very last thing you want to do while undergoing treatment, the evidence is clear; healthy eating, good sleep and exercise is important to maintain after receiving a diagnosis.

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Professor Erica James

Professor Erica James is a exercise scientist and behavioural epidemiologist at the University of Newcastle and the Hunter Medical Research Institute (HMRI).

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ESMO 2020: BREAST CANCER RESEARCH SUMMARY

A summary of some of the key presentations and breast cancer announcements at ESMO Immuno-Oncology Virtual Congress 2020.

European Society For Medical Oncology 2020

Every year, the European Society for Medical Oncology (ESMO) hosts its annual conference, bringing together almost 30,000 clinicians, researchers and patients advocates from around 140 countries.

These oncology professionals share their latest research and advances in treatments and help to translate the latest science into better patient care.

However, like most events this year, ESMO 2020 had to pivot to an online format, allowing researchers to participate across multiple different time zones to ensure they could hear the latest research results and work towards finding new and better treatments for their patients.

New and exciting breast cancer research was presented, and we have provided a summary of some of the key presentations below:

MonarchE Trial Results: Breakthrough In High Risk HR+ Breast Cancer Patient Treatment

The MonarchE clinical trial results have been described as promising for patients with early stage HR+ breast cancer.

Around 70% of breast cancer patients are diagnosed with hormone receptor positive (HR+) disease. Those with HR+ disease that has spread to the lymph nodes, have a large tumour size when diagnosed or have increased cellular proliferation, are considered to be of high risk of recurrence.

These patients were recruited to the MonarchE trial as they had a higher risk of their breast cancer returning in the first two years.

The MonarchE trial found a 25 per cent reduction in recurrence of cancer within the first two years when the CDK 4/6 inhibitor abemaciclib was added to the standard hormone therapy, compared with the hormone therapy alone.

The phase three clinical trial was conducted worldwide and was led by UK researchers. It involved 5,637 patients in 38 countries. Researchers will continue their follow-up assessments to see if the benefit of this treatment continues beyond the two years measured.

SOLAR-1 Trial Results: Survival Benefit For Advanced Breast Cancer Patients With limited Treatment options

Some patients with HR positive, HER2 negative advanced breast cancer could see improved survival thanks to a new drug combination. The SOLAR-1 clinical was open to patients with HR-positive, HER2-negative advanced breast cancer.

This analysis focussed on those who had the PI3KCA gene mutation, which was previously shown to benefit most from a PI3K inhibitor, alpelisib. It showed that by giving this group of patients alpelisib with fulvestrant, patients had an overall survival benefit of eight months, compared to a group taking a placebo and fulvestrant.

It is thought that the PI3K pathway (important in cell growth and survival) can become very active in cancer cells because of mutations in the PIK3CA gene, and that this pathway may be important when resistance to CDK4/6 inhibitors and endocrine therapy develops.

About 40% of HR-positive, HER2 negative breast cancers have a PIK3CA mutation. PIK3CA mutations can be found by testing tumour tissue or blood. A blood test is easy to perform, safe, less invasive than a tumour biopsy and can be repeated regularly.

These results are encouraging as they further support the use of alpelisib plus fulvestrant for patients with HR-positive, HER2-negative advanced breast cancer and PI3KCA mutations, a setting in which treatment options are very limited.

It also gives confidence to the Breast Cancer Trials CAPTURE study that is currently open to patients in Australia.

The CAPTURE clinical trial will check approximately 400 patients with ER+, HER2 negative breast cancer via a blood test to see if they have the PIK3CA gene mutation in ctDNA.

Those participants who have a confirmed PIK3CA gene mutation (approximately 140 (35%)) will be randomised 1:1 to receive alpelisib and fulvestrant (Arm A) or the standard treatment capecitabine (Arm B).

IMpassion 031: Encouraging News For Early Triple Negative Breast Cancer Patients

Data presented at ESMO 2020 from the IMpassion 130 clinical trial is encouraging for patients with early stage triple negative breast cancer.

The IMpassion 031 clinical trial found that neoadjuvant (pre-surgery) treatment with the immunotherapy drug, PD-L1 inhibitor atezolizumab, was associated with a significantly greater pathological complete response rate (no cancer cells left after treatment) when combined with standard chemotherapy.

The patients receiving the trial treatment had a pathological complete response rate of 57.6%, compared with 41.1% for those on chemotherapy alone, in previously untreated patients with early triple negative breast cancer.

IMpassion 031 is a phase three clinical trial that enrolled those with stage two or three triple negative breast cancer. Patients received neoadjuvant atezolizumab or placebo plus nab-paclitaxel followed by standard dose-dense chemotherapy with doxorubicin/cyclophosphamide, prior to surgery. Atezolizumab or placebo was continued after surgery to complete one year of therapy.

Research into triple negative breast cancer is important, as this tumour type is typically associated with earlier recurrence and metastatic spread compared to other forms of breast cancer.

IMpassion 131: Results For Metastatic Triple Negative Patients Not As Encouraging As IMpassion 130 Results

Adding atezolizumab to paclitaxel does not improve progression-free survival or overall survival in patients with locally advanced or metastatic triple negative breast cancer, according to results from the Impassion 131 clinical trial presented at ESMO 2020.

The results of Impassion 131 showed that there was no significant difference between the atezolizumab and placebo arms in their response rates. The findings are in contrast to the IMpassion 031 study above, which enrolled patients with early stage breast cancer rather than metastatic, used nab-paclitaxel instead of paclitaxel. The researchers who led this study have said the potential reasons for such a difference between the two trials requires “further exploration.”

HER2CLIMB: Drug Shown To Improve Survival And Quality Of Life For Patients With HER2-Positive Metastatic Breast Cancer

Results from the HER2CLIMB clinical trial presented a ESMO 2020 has shown that the addition of the drug tucatinib (Tukysa) to trastuzumab (Herceptin) and capecitabine (Xeloda) significant improved progression-free survival and overall survival in patients with HER2-positive metastatic breast cancer, with and without brain metastases.

The results showed that, taken together, this treatment regimen improves survival for this group of patients but also maintains quality of life. In this total cohort of patients on the trial, the risk of death was reduced by 34%. The primary end point of progression free survival by blinded independent central review was assessed in the first 480 patients enrolled.

Overall, risk of progression or death was reduced by 46%. In patients with brain metastases, risk of progression or death was reduced by 52%.

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European Society For Medical Oncology 2020

MonarchE Trial Results: Breakthrough In High Risk HR+ Breast Cancer Patient Treatment

SOLAR-1 Trial Results: Survival Benefit For Advanced Breast Cancer Patients With limited Treatment options

IMpassion 031: Encouraging News For Early Triple Negative Breast Cancer Patients

IMpassion 131: Results For Metastatic Triple Negative Patients Not As Encouraging As IMpassion 130 Results

HER2CLIMB: Drug Shown To Improve Survival And Quality Of Life For Patients With HER2-Positive Metastatic Breast Cancer

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PREDICTING SEXUAL DIFFICULTIES IN PREMENOPAUSAL WOMEN

How clinicians can assist patients in managing a treatment side effect of sexual difficulties.

SOFT/TEXT Clinical Trial Follow-Up

Among premenopausal women with breast cancer, 80% have hormone-responsive breast cancer, where the hormone oestrogen can stimulate the growth of cancer cells.

To stop this from happening after the primary cancer has been removed, women may be treated with one or more drugs that either prevent the uptake of oestrogen by cells (oestrogen blockers like tamoxifen), switch off the production of oestrogen in the ovaries (ovarian function suppression), or block oestrogen production in body fat (aromatase inhibitors).

The SOFT and TEXT clinical trials investigated the effects of different treatment combinations in premenopausal women on survival and recurrence of cancer. Researchers also collected and analysed information about a common and distressing side effect of such treatments: sexual problems including low libido and difficulty becoming aroused.

The impact of treatment on sexual function can be so important for quality of life that it can affect adherence to treatment, says Associate Professor Prue Francis, Chair of the International Steering Committee responsible for the SOFT and TEXT clinical trials.

“Sometimes women just don’t want to take their treatment at all because they’re having problems and they just stop,” says Associate Professor Francis.

The researchers wanted to identify factors that, if present six months into the five-year treatment, predict whether a premenopausal woman will experience sexual difficulties later.

They found that women who reported vaginal dryness, sleep disturbance and bone or joint pain at the six-month mark were more likely to report sexual problems in the first two years.

Recognising these predictors in their patients may guide clinicians to ask about sexual problems, which patients may not otherwise bring up. These conversations might equip clinicians to take a more nuanced and individualised approach to treatment, she says.

Take, for example, a woman experiencing significant side effects from treatment with both aromatase inhibitor and ovarian suppression therapy. Clinicians might consider “the absolute benefit that they’re likely to obtain from having that more intense endocrine therapy,” says Associate Professor Francis.

“Should they really be encouraged to persevere because they have a very high-risk breast cancer and therefore they’re likely to derive more of a differential benefit from that maximal endocrine therapy? Or might their breast cancer not be at such high risk for recurrence, and perhaps it would be reasonable then to dial back to a less intense endocrine approach?”

Publication:

Treatment-induced symptoms, depression and age as predictors of sexual problems in premenopausal women with early breast cancer receiving adjuvant endocrine therapy.

Ribi K, Luo W, Walley BA, Burstein HJ, Chirgwin J, Ansari RH, Salim M, van der Westhuizen A, Abdi E, Francis PA, Chia S, Harvey VJ, Giobbie-Hurder A, Fleming GF, Pagani O, Di Leo A, Colleoni M, Gelber RD, Goldhirsch A, Coates AS, Regan MM, Bernhard J. Breast Cancer Research and Treatment. 2020; 181(2):347-359, epub 09/04/20 doi.org/10.1007/s10549-020-05622-5.

 

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What Is A Clinical Trial?

Who Participates In A Clinical Trial?

Is It Safe To Participate In A Clinical Trial?

What Phases Are Involved During A Clinical Trial?

How Long Do Clinical Trials Take?

What Happens When A Clinical Trial Ends?

Can I Participate In Two Clinical Trials At Once?

Can I Discuss The Clinical Trial With My Family And Friends?

Will My Details Be Published To The Public?

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AUSTRALIAN BREAST CANCER RESEARCHER IN RACE TO FIND CORONAVIRUS VACCINE

Dr Ross Jennens is one of 4,000 Australian health professionals participating in the BRACE clinical trial.

The BRACE Clinical Trial

Dr Ross Jennens is a member of Breast Cancer Trials and is a Medical Oncologist at the Epworth Hospital in Melbourne.

He has been involved in the conduct of a number of clinical trials including the TEXT clinical trial, which produced practice changing results in the treatment of young women with breast cancer.

But with rise of COVID-19 in our community, Dr Jennens is now one of 4,000 health professionals in Australia who are participating in the BRACE clinical trial.

This study aims to test the BCG vaccine, which was developed to prevent tuberculosis and is commonly used as a treatment for people with bladder cancer, to see if it can provide an immune system boost to protect people from COVID-19 symptoms.

We asked Dr Jennens how this Australian trial was developed and what’s involved for health workers.

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Dr Ross Jennens discusses his participation in the BRACE Clinical Trial.

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Dr Ross Jennens is Breast Cancer Trials Researcher and a Medical Oncologist at Epworth Hospital in Melbourne.

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BREAST CANCER RECURRENCE RATES: UNDERSTANDING THE RISK THAT YOUR CANCER WILL RETURN

The rate of breast cancer recurrence is not the same for all patients. Understand the risk of recurrence for your type of breast cancer.

Understanding the Likelihood of Breast Cancer Recurrence Rates

Fear of recurrence – that is, the fear your breast cancer will come back – is a common issue facing women who’ve had early stage breast cancer. Fortunately, Australia has one of the best survival rates of breast cancer in the world, with 91% of women surviving at least five years past their diagnosis. New Zealand is not far behind with 88% of women surviving five years past their first diagnosis.

This information may come as a relief for those diagnosed with early stages (stage 1-3) of the disease, as many recurrences appear within five years after the initial treatment, the exception being ER positive breast cancer, as many recurrences will occur after the first five years as within the first five years. The rate of recurrence is not the same for all breast cancer types or patients. Understanding the risk of recurrence for your type of breast cancer may help to ease some anxiety.

What Is Breast Cancer Recurrence?

Breast cancer recurrence means that the cancer was diagnosed when limited to the breast and/or armpit lymph nodes, then treated, and at some time later has come back.

Breast cancer recurrence occurs in three main ways:

  • Local recurrence: the breast cancer that was previously treated returns within the breast or armpit lymph nodes.
  • New primary breast cancer: an unrelated new breast cancer occurs in one or the other breast.
  • Distant recurrence: The previously treated breast cancer returns in other parts of the body, such as the bones, liver or lungs.

Breast cancer recurrence occurs if:

  • Cells from the original breast cancer diagnosis break away and hide nearby in the breast (called local recurrence) or spread elsewhere in the body (called distant recurrence); AND
  • Treatment, including surgery, chemotherapy, radiotherapy and/or hormone therapy have not gotten rid of all these cancer cells from the body.

These cells can begin to grow right away or can remain dormant for many years before beginning to grow and travel further through the body.

Many breast cancer recurrences are detected in the five years after diagnosis, especially after triple negative breast cancer. However, recurrence can occur more than 20 years after the first diagnosis.

Breast cancer survivors are at risk for developing new cancers for a number of reasons – whatever caused the original cancer could still be having an effect, either on second primaries in the same organ, or on related cancers in other organs. This can be due to genetic predisposition, as is sometimes the case with breast cancer.

What are the Breast Cancer Recurrence Rates for Australia and New Zealand?

Unfortunately, Australia and New Zealand don’t keep track of breast cancer recurrence rates, so it is hard to state the chance of breast cancer returning for the whole population of those diagnosed with breast cancer.

Your individual chance of breast cancer returning depends on a number of factors including the type of breast cancer, tumour size, genetic factors and treatment types.

See more on risk factors for breast cancer recurrence.

What Types of Breast Cancer have the Highest Recurrence Rates?

A study published in the Journal of Clinical Oncology found the rate of recurrence for all breast cancers was highest in the first five years from the initial cancer diagnosis at 10.4%. Specifically, the risk was highest between the first and second years after the initial diagnosis.

During the first five years after the initial diagnosis, patients with oestrogen receptor (ER) positive breast cancer had lower rates of recurrence compared with those with ER negative disease. However, beyond five years, patients with ER positive disease had higher rates of recurrence.

Who Is At Risk Of Breast Cancer Recurrence?

Everyone who has received a breast cancer diagnosis is at risk of recurrence, however the risk differs markedly depending on a number of factors listed below.

  • Lower risk recurrence: Some breast cancer, when diagnosed very early when small and without lymph node involvement, have an excellent prognosis and are very unlikely to recur.
  • Greater risk of recurrence: Larger cancers, with lymph node involvement or with a more invasive behavior, unfortunately have a higher risk of returning.

What Factors Contribute To The Risk of Breast Cancer Recurrence?

Whilst it is never completely certain that breast cancer has been cured, there are many treatments available that reduce the risk of recurrence. There are also a number of risk factors that can contribute to the rate of breast cancer recurrence.

  • Your age at first diagnosis: Younger women, particularly those who had their first diagnosis under the age of 35, have a greater risk of breast cancer. This is because those diagnosed at a young age are more likely to have aggressive features in their breast cancer. Additionally women diagnosed with breast cancer before menopause have a greater risk of recurrence.
  • Tumour size: Women who have a larger breast tumour have a greater risk of recurrence.
  • Lifestyle factors: Excess weight is associated with a higher risk of postmenopausal breast cancer and is also associated with a higher risk of breast cancer recurrence and death. Smoking has also been shown to increase the risk of recurrence. Women who exercise regularly (at least half an hour per day of moderate intensity exercise, 5 days per week) appear to have a lower rate of breast cancer recurrence.
  • Lymph node involvement: If cancer is found in lymph nodes at the time of the original breast cancer diagnosis, there is an increased risk of breast cancer recurrence. This is the strongest prognostic factor, and the more nodes involved, the higher the risk of recurrence.

How Does The BRCA1 or BRCA2 Gene Mutation Affect My Risk Of Breast Cancer Recurrence?

Women with a BRCA1 or BRCA2 gene mutation and who have already been diagnosed with breast cancer, have a higher-than-average chance of new primary breast cancers than those without this genetic mutation. The rate of local or distant recurrence depends on the type and stage of the original breast cancer, and is no different from a non-BRCA-mutated breast cancer.

For women with a BRCA1 or BRCA2 gene mutation, the rate of contralateral breast cancer, or cancer in the opposite breast to the original cancer, 10 years after diagnosis of the first cancer is about 10-30 percent, compared to about 5-10 percent for women diagnosed with breast cancer who do not have a BRCA1 or BRCA2 gene mutation.

Women who have a BRCA1 or BRCA2 gene mutation and have received a breast cancer diagnosis should talk to their treatment team about their options to reduce their risk of breast cancer recurrence.

What Are The Signs Of Breast Cancer Recurrence?

If you have a local recurrence or new primary breast cancer, you may find symptoms similar to an initial breast cancer.

These include:

  • A new lump in the breast, armpit area or around the collarbone
  • A change in breast size or shape
  • Changes to the nipple, such as sores or crusting, an ulcer or inverted nipple
  • Clear or bloody nipple discharge
  • Changes to the skin including redness, puckering or dimpling (an ‘orange peel’ appearance)
  • Breast tenderness or pain

If your breast cancer has spread to other parts to the body, known as distant recurrence, there are a number of possible symptoms, including:

  • Fatigue
  • Breathlessness
  • Pain in your bones
  • Unexpected weight loss or change in appetite
  • Severe or ongoing headaches
  • Nausea

However, symptoms will vary depending on where the secondary cancer presents, and some primary and secondary cancers may not present any obvious symptoms. Sometimes breast cancer recurrence is identified on a scan or blood test that was done for a reason other than the cancer itself.

If you have any health concerns or symptoms that are new or persistent, speak with your GP or treating physician.

Should I Have Scans Or Blood Tests To Check For Breast Cancer?

After a diagnosis of early stage breast cancer, any remaining breast tissue should be evaluated with scans (such as mammogram or ultrasound) regularly. The frequency is often annually but is best discussed with your specialist(s).

Current guidelines and evidence recommend against routine CT or bone scans, or blood tests, to look for recurrence of cancer in patients who do not have any symptoms or other concerns that need to be followed up on. These tests have not been shown to improve outcomes and cause unnecessary ‘scanxiety’. If you do have concerning symptoms (such as those mentioned above), then you should bring them to the attention of your healthcare team to be checked out.

Am I Still At Risk Of Breast Cancer Recurrence If I Have Had A Mastectomy?

Yes. You are still at risk of breast cancer recurrence if you have had a bilateral mastectomy (surgical removal of both breasts). Undergoing a bilateral mastectomy drastically reduces your chances of local or contralateral breast cancer recurrence as almost all of the breast tissue has been removed. However, there is still a chance that residual breast tissue or cancer cells could recur on the chest wall.

If you have had a single mastectomy (surgical removal of one breast), you are still at risk of developing cancer in the breast that remains.

It must be noted that having a mastectomy or bi-lateral mastectomy does not reduce your risk of developing cancer in other parts of your body (distant recurrence).

How Can I Prevent Breast Cancer Recurrence?

There is no definitive way to prevent breast cancer from coming back. However, treatments such as surgery, chemotherapy, radiotherapy, targeted therapy (eg trastuzumab for HER2-positive breast cancer) and/or hormone therapy (for hormone receptor positive breast cancer) do reduce the risk of recurrence, depending on the type and stage of the cancer. These can be discussed with your treatment team.

Understanding the risk factors for breast cancer recurrence and participating in regular breast screening through BreastScreen in Australia and BreastScreen Aotearoa in New Zealand can help to pick up any breast changes. Discussion with your healthcare team can help to catch any changes or abnormalities early and act on them.

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