Pfizer and the Alliance Foundation Trials have partnered with six international cancer research groups to initiate a Phase III clinical trial (PATINA) of palbociclib (IBRANCE) in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer.
Palbociclib is being developed as an inhibitor of cyclin-dependent kinases (CDK) 4 and 6 that are involved in regulation of the cell cycle associated with cellular progression.
The international, randomised, open-label, multi-centre Phase III trial will compare the combination of palbociclib, anti-HER2 therapy and endocrine therapy with standard therapy as a first-line treatment in a total of 500 patients.
For trial availability across the US, Europe, Australia and New Zealand, the firms have partnered with Mastering Breast Cancer Initiative, PrECOG, German Breast Group, Fondazione Michelangelo, SOLTI Breast Cancer Research Group and Australia and New Zealand Breast Cancer Trials Group (ANZBCTG).
Pfizer Oncology chief medical officer Charles Hugh-Jones said: “We are pleased to partner with these prominent research groups to explore the use of palbociclib in first-line HR+, HER2+ disease.
“PATINA is the first randomised, 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.”
During the trial, subjects will be randomised into one of two treatment arms after receiving six to eight cycles of chemotherapy with anti-HER2 therapy.
While one arm will include the administration of 125mg of oral once daily palbociclib for 21 days and a subsequent seven days of treatment period plus standard anti-HER2 therapy and endocrine therapy until disease progression, the other arm will involve only standard anti-HER2 therapy and endocrine therapy.