By: PBR Staff Writer
Pfizer, along with Alliance Foundation Trials (AFT) and six other international cancer research groups, has commenced a phase 3 clinical study to assess palbociclib (Ibrance) for the treatment of patients with metastatic breast cancer.
Ibrance is an oral inhibitor of cyclin-dependent kinase 4/6 (CDK 4/6), which triggers cellular progression.
Patina is a randomized, open-label and phase 3 clinical trial, which will assess palbociclib in combination with anti-HER2 therapy and endocrine therapy against 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.
In the US, Ibrance secured approval to treat HR+ and 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.
The trial will recruit women or men with HR+, HER2+ metastatic breast cancer following completion of induction with anti-HER2 based chemotherapy. The will be randomized to one of two treatment arms after completing.
One study arm will evaluate patients with palbociclib and standard anti-HER2 therapy and endocrine therapy until disease progression, while other study arm will assess patients with standard anti-HER2 therapy and endocrine therapy until disease progression.
Around 500 patients will be enrolled in the trial across the globe.
Pfizer is offering financial support for the trial, while AFT is the global sponsor for the study being carried out in the US, Germany, Italy, Spain, Australia, and New Zealand.
Other research groups participating in the trial are PrECOG, German Breast Group (GBG), SOLTI Breast Cancer Research Group, Fondazione Michelangelo and Australia New Zealand Breast Cancer Trial Group.
Alliance Foundation Trials president and CEO Dr Monica Bertagnolli said: “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.”
Pfizer Oncology chief medical officer Dr Charles Hugh-Jones said: “Patina is the first randomized, Phase 3 trial of a CDK 4/6 inhibitor in this setting.”
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.