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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 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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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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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 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 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.

Listen to the podcast

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?”

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 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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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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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

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.

Help support a future free from the fear of breast cancer recurrence

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ASCO 2020: BREAST CANCER RESEARCH SUMMARY

Read our summary of the key breast cancer clinical trials research presented at 2020 American Society of Clinical Oncology (ASCO) Annual Meeting.

American Society of Clinical Oncology 2020

The American Society of Clinical Oncology (ASCO) congress is the largest cancer conference in the world, bringing together the world’s most reputable cancer researchers, patient advocates and industry professionals, including those from Breast Cancer Trials, to discuss the latest advancements in cancer treatments, clinical trials research and cancer care.

This year, due to COVID-19 restrictions, the conference went online, with delegates logging in at all hours of the day around the world to attend sessions and lectures.

We have provided a summary of the key breast cancer clinical trials research presented:

KEYNOTE355 Clinical Trial Shows Positive Survival Data For Metastatic Triple Negative Breast Cancer

The KEYNOTE355 clinical trial was a phase three trial that evaluated an immunotherapy drug (pembrolizumab) in combination with (one of three) chemotherapy drug regimens, compared to those chemotherapy drugs alone.

This trial was open to patients with inoperable locally recurrent or metastatic triple negative breast cancer. This means the patients’ cancer has come back after treatment or has spread to other parts of the body and is unable to be removed in an operation.

Results presented at ASCO 2020 show that in patients with programmed cell death ligand (PD-L1) positive tumours with a combined positive score (CPS) equal to or more than 10, the immunotherapy plus chemotherapy treatment led to a statistically significant and clinically meaningful improvement in the amount of time patients lived without progression of their cancer.

This combination of treatment reduced the risk of disease progression or death by 35% and improved the progression-free survival to an average of 9.7 months compared to the 5.6 months for patients receiving only chemotherapy. There were some additional, manageable, immune related side effects seen with pembrolizumab.

The researchers and clinicians who worked on this trial believe that if approved, this new treatment combination could provide a new option for first-line treatment to certain patients with hard-to-treat triple-negative breast cancer.

Should The Primary Breast Cancer Be Removed In Patients Who Have Distant Metastases At The Time Of Diagnosis?

This is a question that patients and doctors frequently discuss in the clinic. Women who present with a new diagnosis of breast cancer that is already at an advanced stage (stage IV) face the question about whether surgery and radiation to the tumour of the breast (local therapy) will prolong survival compared to the traditional treatment of systemic treatment (chemotherapy or endocrine therapy) alone. The question comes down to concern about whether the primary cancer contributes to further progression of distant disease.

Data from the E2108 randomised phase three trial, presented at ASCO 2020, show that the survival experience of the two treatments was the same. Patients all started with systemic therapy, and those who had stable or responding disease were then randomised to receive surgery to the breast primary, followed by ongoing systemic therapy, or to ongoing systemic therapy alone.

Those patients who received local therapy did not survive for any longer than those who did not. It shows that surgery and radiation should not be offered to these patients with the expectation of improved survival. There may still be specific situations where surgery and/or radiotherapy to the breast may be worthwhile for patients with metastatic breast cancer, particularly if it is causing localised symptoms that are not controlled by systemic therapy. In addition, quality of life was worse in the patients who had surgery, despite having less locoregional progression.

Improved Survival For Patients With HER2 Positive Breast Cancer With Brain Metastases

Results of the HER2CLIMB clinical trial were presented at ASCO2020 showed remarkable results for patients with HER2 positive breast cancer with brain metastases. This type of cancer is often difficult to control when it has spread to the brain, resulting in short survival times.

The HER2CLIMB clinical trial was a randomised phase 2 trial which evaluated the addition of an oral drug (tucatinib) to treatment with Capecitabine and trastuzumab in patients with advanced HER2+ breast cancer that had spread to other parts of the body. The overall results have already been published, showing tucatinib prolongs survival in patients with metastatic HER2 positive breast cancer. The results presented at ASCO2020 focused on patients whose breast cancer had metastasised to the brain.

These results showed an overall survival benefit in this group of patients, which is around 50% of all HER2 positive metastatic breast cancer. The investigators found that in patients with heavily pre-treated, HER2 positive metastatic breast cancer with brain metastasis, the addition of the drug tucatinib to the combination of trastuzumab and capecitabine doubled the intracranial overall response rate, reduced the risk of intracranial progression or death by two-thirds and reduced the risk of death by half. It was also effective for patients without brain metastases.

Trastuzumab Does Not Reduce The Risk Of Recurrence For Women With HER2-Positive DCIS

Trastuzumab, one of the drugs used in the HER2CLIMB trial discussed above, was also used in the NSABP B-43 clinical trial. Trastuzumab is an established drug that reduces recurrence and prolongs disease control in early stage and metastatic HER2 positive invasive breast cancer, respectively.

The aim of this clinical trial was to see if the addition of trastuzumab to radiotherapy would reduce the pre-cancerous (DCIS) or invasive breast cancer recurrence rate for women who have had surgical removal of HER2 positive ductal carcinoma in situ (DCIS). The investigators hoped it would reduce the rate of recurrence by at least 36%, however results presented at ASCO 2020 showed it did not reach this threshold.

BYLIEVE Results Show Treatment Combination Improves Progression Free Survival For Patients With Metastatic ER-Positive, PIK3CA Mutant Breast Cancer

PIK3CA mutations are found in the tumours of approximately 40% of patients with hormone receptor-positive, HER2-negative advanced breast cancer, and is associated with treatment resistance and poor outcomes. The BYLIEVE clinical trial treated patients with metastatic hormone receptor-positive, PIK3CA mutant breast cancer with the combination of alpelisib, an alpha-specific PI3K inhibitor, and fulvestrant after prior aromatase inhibitor and CDK4/6 inhibitor treatment.

The results, presented at ASCO 2020, showed that the trial met its primary objective, with 50% of patients alive and progression free at six months. Some toxicity was identified (diarrhoea, hyperglycaemia, nausea, rash), but discontinuation due to toxicity was low, suggesting that it is manageable.

This trial result is of great interest to Breast Cancer Trials as the CAPTURE clinical trial, due to open in late 2020, will use the same combination of alpelisib and fulvestrant in patients with hormone receptor-positive HER2-negative advanced breast cancer who have a PIK3CA mutation in their blood, according to testing of circulating DNA.

While BYLIEVE was a single-arm trial, the CAPTURE trial will compare this treatment to capecitabine, which is a currently used treatment option. Such comparative trial designs are the accepted standard for moving new medications or combinations towards routine clinical use.

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ESMO 2020 BREAST CANCER VIRTUAL MEETING SUMMARY

Read our summary of some of the key breast cancer research presented at this year’s ESMO 2020.

European Society of Medical Oncology 2020

Every year the European Society of Medical Oncology (ESMO) hosts a multidisciplinary meeting in Europe, bringing together the world’s best cancer researchers to present on the latest in breast cancer research and treatments and to help design the next generation of clinical trials.

This year due to COVID-19 restrictions the meeting went virtual, with delegates logging on from all over the world to the ESMO 2020 Breast Cancer Virtual Meeting. ESMO 2020 is a congress designed for researchers and clinicians who have a specific interest in innovation (including translational research, new agents, molecular and functional diagnostics, biomarkers and cutting-edge research applications in the clinical setting) and care.

We have provided a summary of some of the key research presented at this year’s ESMO 2020.

Immunotherapy Benefit In Metastatic Breast Cancer

Two novel biomarkers (which are a way to measure what is happening in a cell or organism at any given moment) have been found to be connected with improved outcomes in those with metastatic breast cancer. It is hoped these biomarkers will help identify which patients will benefit most from immunotherapy treatments, according to exploratory studies reported at ESMO 2020.

Previous studies have shown that not every patient with metastatic breast cancer will benefit from immunotherapy treatments. Immunotherapy is a type of cancer treatment which aids the body’s immune system to fight cancer cells. Trials have focussed on patients with triple negative breast cancer and more recently HER2-positive breast cancer. However, these traditional biomarkers have not been specific enough.

To explore new potential biomarkers for immunotherapy in advanced breast cancer, researchers assessed the predictive value of copy number alteration (CNA) for the PDL1 gene (a biomarker), which measures whether the gene number has decreased, remained the same or increased. They measured CNA values in tumour tissue collected from 126 patients with metastatic breast cancer taking part in the SAFIR-IMMUNO study, the first randomised trial comparing immunotherapy using durvalumab, to maintenance chemotherapy in this setting.

The study found that nearly one in four patients had a copy gain or amplification of the PDL1 gene. This exploratory translational analysis suggested a higher efficacy of durvalumab as maintenance treatment for patients with PDL1 copy gain or amplification. Further research is needed, but the study authors suggest that this could help to identify metastatic patients that immunotherapy could benefit.

The second potential immunotherapy biomarker involved a different method of PD-L1 measurement, the combined positive score (CPS). This may also predict for increased benefit with immunotherapy.

Breast Cancer Trials currently has one immunotherapy trial open to metastatic breast cancer patients.

You can read more about the DIAmOND clinical trial here.

The Drug Trastuzumab Deruxtecan Shows Promise For Metastatic HER-2 Positive Breast Cancer

Trastuzumab deruxtecan is a new type of drug called an antibody-drug conjugate, that combines a targeted therapy with a chemotherapy payload directed only at the cells that exhibit a specific signal, in this case, HER2. A trial using this drug has shown benefits in patients with HER-2 positive metastatic breast cancer who have already received previous treatments.

In a study of 184 patients who had already undergone an average of six previous treatments, 60% of patients had a positive response to the drug, resulting in the average duration of progression free survival being around 16 months.

This is impressive, because typically very few tumours would respond to treatment after so many other treatments have already failed.

While further study is required to confirm the efficiency of this drug in a larger patient population, this result is positive for those with metastatic HER-2 positive breast cancer.

Read the full study: Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer Published December 11, 2019

Supportive Care and Physical Activity Underutilised To Help Cancer Related Fatigue

Cancer related fatigue is common for those who have received breast cancer treatment and can prevent patients from returning to life as they lived before their diagnosis. A study presented at ESMO 2020 has found that this fatigue may be due to early breast cancer patients not adhering to the recommended guidelines of physical activity.

The study found patients who reported severe levels of fatigue were less like than those with non-severe symptoms to have followed physical activity guidelines for cancer patients. The study’s authors said the take-away from these results is that patients need to be encouraged to stay active and understand that it is physical activity and not rest which will help them to overcome fatigue.

In the patient population studied, it was also found that the uptake of supportive services was low, with only one out of 10 women consulting a psychologist.

This study shows that the strategies patients adopt to help manage side effects like fatigue are strongly connected to the type and intensity of their fatigue. Ideally, people with a history of cancer should aim towards 30 minutes per day, five days per week of moderately strenuous physical activity (or more).

This may require support from health professionals and accredited exercise physiologists. The authors state that even though physical activity has been proven to reduce cancer related fatigue, it needs to form part of a more holistic treatment plan that includes access to other support services like a psychologist.

You can read more about the importance of getting psychological help during your cancer diagnosis here.

Circulating Tumour DNA Is Emerging As An Important Aspect Of Breast Cancer Monitoring And Prediction

Circulating tumour DNA is found in the blood and refers to the DNA that comes from cancerous cells and tumours. As a cancer grows, cancer cells die and are replaced by new ones. The dead cells get broken down and their contents, including DNA, go into the bloodstream. These very small pieces of DNA are called circulating tumour DNA (ctDNA).

Circulating tumour DNA was identified at ESMO 2020 to be of increasing research interest. This is because circulating tumour DNA can be used in detecting and diagnosis a tumour, guiding tumour-specific treatment, monitoring treatment and monitoring patients in remission.

Breast Cancer Trials will open the CAPTURE clinical trial this year, which uses a blood test for circulating tumour DNA to detect if a patient has the PIKC3A gene mutation. This mutation occurs in 35-40% of oestrogen receptor positive (ER+) breast cancer and may make tumours more sensitive to treatments such as alpelisib that target the PI3K pathway.

The study aims to find out if treatment with alpelisib plus fulvestrant increases survival without cancer progression compared to capecitabine in women and men with oestrogen receptor positive (ER+), HER2-negative advanced breast cancer who have a PIKC3A mutation identified in circulating tumour DNA (ctDNA).

Other Trial Results Presented At The ESMO Congress

  • KATHERINE trial: post-neoadjuvant TDM-1 is effective, even if the tumour converts from HER2-positive at pre-therapy biopsy to HER2-negative at surgery.
  • PALOMA-3: patients have prolonged progression-free survival on their next line of therapy after palbociclib and fulvestrant.
  • Tumour infiltrating lymphocytes on tumour biopsy and immunoscore predict for pathological complete response in patients with operable breast cancer treated with neoadjuvant immunotherapy.
  • Another mouthful – Ladiratuzumab Vedotin! This time an antibody drug conjugate (like TDM-1) for triple negative breast cancer (TNBC). This early phase trial demonstrated a 35% response rate in the overall trial population, and 69% in de novo metastatic TNBC.
  • Window-of-opportunity trials, where patients are given a short duration (eg two weeks) of chemo- or endocrine therapy with serial biopsies, might be of increasing interest, as presented by an eminent cancer researcher at an educational session during the meeting.
  • Tucatinib (HER2Climb) in heavily pre-treated metastatic HER2-positive breast cancer prolongs progression-free and overall survival even in the difficult to treat, poor prognosis group with brain metastases.

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strength in science – elissa’s participation in the optima clinical trial
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