Pre-clinical data showed the role of CDK 4/6 inhibition in HER2+ disease. Results from phase 2 clinical trials point to synergistic antitumor activity and potential efficacy of palbociclib when given in combination with anti-HER2 therapy (tx), particularly in HR+/HER2+ breast cancer. The aim of PATINA is to evaluate the efficacy and safety of the addition of palbociclib to anti-HER2 tx and ET maintenance after induction tx in the 1st line setting for HR+/HER2+ MBC.
The PATINA trial (AFT-38/NCT02947685) is a pivotal, open-label, international, phase III study. The trial is open to patients (pts) with histologically confirmed HR+/HER2+ MBC provided they are without evidence of disease progression by local assessment after induction tx. Following 4-8 cycles of chemotherapy (taxane or vinorelbine) with anti-HER2 tx for MBC, pts will be randomized 1:1 to standard anti-HER2 tx (trastuzumab +/- pertuzumab) in combination with ET with or without palbociclib until disease progression. ET options are either an aromatase inhibitor or fulvestrant. Premenopausal women must receive LHRH agonist. Total planned accrual is 496 pts. Primary objective is to demonstrate that the combination of palbociclib with anti-HER2 tx plus ET is superior to anti-HER2 tx plus ET alone in prolonging progression-free survival (PFS). Key secondary objectives are measures of tumor control, overall survival, safety and quality of life. The main translational science objective is to compare PFS estimates according to PIK3CA mutation status. All pts approached to participate in PATINA will be asked to share remaining biospecimens with the Mastering Breast Cancer Initiative. This initiative was created in order to understand the natural history of MBC and how it envolves over time with the aim to develop new treatments for this patient population. Recruitment has started in 07/2017 and is expected to take place across approximately 130 sites in Australia, Germany, Italy, New Zealand, Spain, and the US.
Clinical trial identification
Legal entity responsible for the study
Alliance Foundation Trials (AFT) in collaboration with GBG Forschungs GmbH.
The study is sponsored by Alliance Foundation Trials (AFT) and financially supported by Pfizer.
S. Loibl: Grants: AbbVie, Amgen, AstraZeneca, Celgene, Novartis, Pfizer, Roche, Teva, Vifor during the conduct of the study as well as outside the submitted work. D. Tripathy: Personal fees: Pfizer, during the conduct of the study. C. Huang: Other: Pfizer , during the conduct of the study. M.P. Goetz: Other: Biovica, Novartis, Sermonix, Genomic Health; Grants and other: Lilly; Grants: Pfizer, outside the submitted work. S. Loi: Consultant (not compensated): Seattle Genetics, Pfizer, Novartis, BMS, Merck and Roche-Genentech. All other authors have declared no conflicts of interest.