POSITIVE RESULTS FOR APHINITY CLINICAL TRIAL

A six-year analysis of the APHINITY clinical trial shows that adding pertuzumab to standard treatment with trastuzumab Herceptin and chemotherapy, reduces the risk of recurrence in patients with HER2-positive breast cancer.

The findings were presented at the San Antonio Breast Cancer Symposium in the United States.

After six years of follow-up, researchers found that:

· Patients who received pertuzumab had a 24% reduced relative risk of breast cancer recurrence or death compared with those who received standard chemotherapy and Herceptin.

· Patients whose cancer had spread to the lymph nodes continued to derive greatest clinical benefit with the addition of pertuzumab to standard treatments.

· Among patients with node-positive disease, the invasive disease–free survival in the pertuzumab arm was 87.9%, while the invasive disease–free survival in the standard treatment arm was 83.4%.

Over 4,000 women participated in this international clinical trial, including 128 from Australia and New Zealand. The APHINITY trial was led by the Breast International Group and conducted in Australia and New Zealand by Breast Cancer Trials (BCT).

The BCT Study Chair of APHINITY, Associate Professor Nicholas Wilcken, says that while fewer deaths were seen in patients treated with pertuzumab, the overall survival benefit was not statistically significant at this time.

“While these initial results are positive, longer follow-up is needed to see if there will be any significant survival benefit of adding pertuzumab to current treatments,” Associate Professor Wilcken said.

“Further analysis will also tell us which patients will benefit most from adding this new treatment.”

Previous research conducted in the HERA clinical trial, revolutionised the treatment of HER2-positive breast cancer, with the addition of trastuzumab (Herceptin) to chemotherapy after surgery. This significantly reduced the risk of breast cancer returning by 46%. HER2-positive breast cancer is a more aggressive form of the disease affecting approximately 20-30% of women with breast cancer and approximately 30% of patients will still experience recurrence of their disease.

“Through the APHINITY clinical trial, we are investigating whether adding a different yet complementary HER2 inhibitor – pertuzumab – to standard treatment with Herceptin and chemotherapy, will further reduce the risk of recurrence and advanced disease for these patients.”

Breast Cancer Trials – www.breastcancertrials.org.au – has been conducting clinical trials research for more than 40 years and the results have improved the treatment of the disease which has saved millions of lives through research collaboration. The research program brings together about 800 researchers in 102 institutions throughout Australia and New Zealand. More than 15,700 women have participated in BCT clinical trials.

Media contact: Anna Fitzgerald, BCT Communications Manager 0400 304 224 or anna.fitzgerald@bctrials.org.au

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