The Alliance Foundation Trials (AFT) — in conjunction with Pfizer and six international cancer research groups — has launched a randomised open-label Phase III clinical study, PATINA, to evaluate a combination therapy for breast cancer.
breast cancer
This trial will specifically look at a cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor, palbociclib (also known as IBRANCE), in combination with anti-HER2 therapy and endocrine therapy as a first-line treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer. It will be compared with the current standard therapy.
“The PATINA trial offers an exciting opportunity for a new global collaborative initiative among clinical trial groups aimed at improving the treatment of women with metastatic breast cancer,” said Dr Monica M. Bertagnolli, president and CEO of Alliance Foundation Trials, and group chair and principal investigator of the Alliance for Clinical Trials in Oncology. “Our partnership with the Mastering Breast Cancer Initiative, PrECOG, the German Breast Group, Fondazione Michelangelo, SOLTI Breast Cancer Research Group and the Australia and New Zealand Breast Cancer Trials Group (ANZBCTG) makes this trial available to patients across the US, Europe, Australia and New Zealand. PATINA is the first study of the Mastering Breast Cancer Initiative which is an umbrella organisation that includes multiple clinical trials whose participants will contribute medical information and biological specimens for future research. This initiative was created in order to understand the natural history of breast cancer and how it evolves over time with the overall goal to develop new treatments for this patient population.”
Pre-clinical data and preliminary results from the early phase clinical trials have indicated the potential efficacy of the therapeutic combination.
“The current PATINA study is built on strong pre-clinical and clinical rationale demonstrating the potential of palbociclib when given in combination with endocrine therapy and anti-HER2 therapies,” said Dr Otto Metzger, principal investigator of the trial for AFT and Medical Oncologist at the Dana-Farber Cancer Institute in Boston. “We hope that this trial will show that the addition of palbociclib to the first-line treatment of HR+, HER2+ disease will help delay the onset of therapeutic resistance to endocrine therapy, complement the benefits of anti-HER2 therapy and ultimately improve patient outcomes. The study also includes a comprehensive molecular characterization of the disease when patients enter the study and at the time of disease progression.”
“We are pleased to partner with these prominent research groups to explore the use of palbociclib in first-line HR+, HER2+ disease,” said Dr Charles Hugh-Jones, FRCP, chief medical officer, Pfizer Oncology. “PATINA is the first randomized, Phase III trial of a CDK 4/6 inhibitor in this setting. Collaborations of this kind are critical to advance our understanding of how we can treat breast cancer, and they represent an important part of Pfizer’s clinical development programme for palbociclib.”