The Alliance Foundation Trials, LLC (AFT), in conjunction with Pfizer and six international cancer research groups, has announced the launch of the PATINA study.
PATINA is a randomized, open-label, Phase 3 clinical study which is intended to specifically look into 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.
About 500 participants will be recruited worldwide for the study, with the first patient already prepped last month.
Dr Charles Hugh-Jones, chief medical officer at Pfizer Oncology, said: “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.”
“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 early phase clinical trials point to the potential efficacy of palbociclib when combined with anti-HER2 therapies and endocrine therapy. About 10-15% of patients with metastatic breast cancer are HR+, HER2+.1 Palbociclib is currently not approved for use in this patient population in any country.
“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 Otto Metzger, MD, 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.”
The PATINA trial is a pivotal, open-label, international, multicenter, randomized Phase 3 study. The trial is open to women or men with HR+, HER2+ metastatic breast cancer following completion of induction with anti-HER2 based chemotherapy. Participants will be randomized (selected by chance) to one of two treatment arms following 6-8 cycles of chemotherapy with anti-HER2 therapy.
One study arm will treat patients with palbociclib (at a dose of 125 mg orally once daily for 21 days followed by seven days off treatment in a 28-day cycle) and standard anti-HER2 therapy and endocrine therapy until disease progression.
The other study arm will treat patients with standard anti-HER2 therapy and endocrine therapy until disease progression. About 500 participants will be recruited worldwide.
Currently, the new study is open to physicians and medical facilities throughout the U.S. if they are associated with the Alliance Foundation and PrECOG oncology research groups.
The study will be available to non-U.S. sites this fall through an extended academic core network that includes the German Breast Group (GBG), Fondazione Michelangelo, SOLTI Breast Cancer Research Group, and the Australia and New Zealand Breast Cancer Trials Group (ANZBCTG).
