On August 22, 2017 The Alliance Foundation Trials, LLC (AFT), in conjunction with Pfizer and six international cancer research groups, reported the launch of PATINA – a randomized, open-label, Phase 3 clinical study of the cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor palbociclib (also known as IBRANCE) (Press release, Pfizer, AUG 22, 2017, View Source [SID1234520297]). The PATINA trial will evaluate palbociclib in combination with anti-HER2 therapy and endocrine therapy versus standard therapy as a first-line treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer. The trial randomized its first patient on July 26, 2017.
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"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 Monica M. Bertagnolli, MD, President and Chief Executive Officer of Alliance Foundation Trials, LLC, 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 U.S., Europe, Australia and New Zealand. PATINA is the first study of the Mastering Breast Cancer Initiative which is an umbrella organization 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."
In the U.S., IBRANCE is indicated for the treatment of HR+, HER2-negative (HER2-) advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women, or fulvestrant in women with disease progression following endocrine therapy. Since its initial FDA approval in 2015, more than 60,000 patients have been treated with IBRANCE in the U.S. alone.
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."
"We are pleased to partner with these prominent research groups to explore the use of palbociclib in first-line HR+, HER2+ disease," said Charles Hugh-Jones, MD FRCP, Chief Medical Officer, Pfizer Oncology. "PATINA is the first randomized, Phase 3 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 program for palbociclib."
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.
Alliance Foundation Trials, LLC, under the auspices of the Alliance for Clinical Trials in Oncology, has brought together a collaborative group of breast cancer specialists from around the world to team up with a pharmaceutical sponsor to form a public-private cancer research partnership aimed at bringing more innovative therapies to patients in more efficient ways.
For questions about this trial, please contact the PATINA study at [email protected].
Availability
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).
Information on the PATINA study can be found on the National Institutes of Health (NIH) registry of clinical trials, www.clinicaltrials.gov (Clinicaltrials.gov Identifier: NCT02947685), and on the PATINA website at www.patina-trial.com.
Funding and Sponsorship
Pfizer, the manufacturer of palbociclib (IBRANCE), is providing funding support for this trial. AFT is the global sponsor of this trial which will be conducted in the U.S., Germany, Italy, Spain, Australia, and New Zealand.