FINER CLINICAL TRIAL SHOWS PROMISING RESULTS FOR METASTATIC BREAST CANCER PATIENTS

The results of the FINER clinical trial have shown that the addition of the drug ipatasertib to standard treatment extends how long we can control oestrogen receptor positive (ER+) and HER-2 negative metastatic breast cancer in patients.

The FINER trial was conducted by Breast Cancer Trials in partnership with the Canadian Cancer Trials Group. It enrolled 250 women and men with oestrogen receptor positive (ER+) and HER-2 negative metastatic breast cancer to participate, who were randomly assigned to receive the new drug or a placebo in conjunction with standard treatment with fulvestrant, which is an anti-estrogen medication.

Patients with this type of breast cancer are routinely given tablet drugs called CDK 4/6 inhibitors, along with antihormone treatment as their first anti-cancer therapy. However, in most cases this common type of advanced cancer eventually grows or spreads despite this initial treatment. This loss of effectiveness means we need to switch to other treatments to regain control of these resistant cancers.

The main objective of this study was to examine whether treatment with ipatasertib plus fulvestrant was better than fulvestrant alone, in controlling the growth of these metastatic breast cancers after CDK 4/6 inhibitor treatments had stopped working. The measure used to compare the treatments was the length of Progression Free Survival (PFS), the time from commencing study treatment until the detection of progression (worsening) of the disease.

Researchers found that adding ipatasertib to fulvestrant significantly prolonged the Progression Free Survival of patients, when compared to those who received the placebo and fulvestrant. The addition of ipatasertib controlled the progress of metastatic breast cancer for almost three times as long, with a median PFS of 5.32 months compared to 1.94 months.

In addition, patients who had a detectable gene mutation in the AKT pathway present in their blood, the part of the cell that ipatasertib targets, had even more favourable results, with a median PFS of 5.45 months.

Associate Professor Andrew Redfern, who is the Study Chair of the FINER clinical trial, says the results are significant for these patients with advanced disease.

“This treatment is an exciting next step for patients with metastatic breast cancer, providing the benefits of longer cancer control which will hopefully translate into a longer and healthier life,” explained Associate Professor Redfern.

“It could potentially help up to 1,500 people in Australia every year who are diagnosed with this type of breast cancer, offering a new treatment option for these patients. We now need to confirm these results both with longer follow-up of the patients on this trial as well as with further research.”

Founded in 1978, Breast Cancer Trials conducts a multicentre national and international clinical trials research program, into the treatment and prevention of breast cancer. More than 980 researchers in 118 institutions across Australia and New Zealand are committed to our vision of no more lives cut short.

For more information about Breast Cancer Trials, visit www.breastcancertrials.org.au.

Contact: BCT Media & PR Lead, Sara McGregor – 0424 591 241 or sara.mcgregor@bctrials.org.au

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