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Pfizer Provides Update on Phase 3 PALLAS Trial of IBRANCE® (palbociclib) Plus Endocrine Therapy in HR+, HER2- Early Breast Cancer

(Pfizer) May 29, 2020 - As announced today by the Austrian Breast & Colorectal Cancer Study Group and the Alliance Foundation Trials, LLC, Pfizer Inc. reports that following a preplanned efficacy and futility analysis, the independent Data Monitoring Committee (DMC) of the collaborative Phase 3 early breast cancer PALbociclib CoLlaborative Adjuvant Study (PALLAS) determined that the trial is unlikely to show a statistically significant improvement in the primary endpoint of invasive disease-free survival (iDFS). Patients currently receiving palbociclib in the study will be advised about next steps by their physicians and long-term follow up of all patients will proceed as planned. No unexpected new safety signals were observed in patients receiving palbociclib.

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Dean Gesme (Posted: May 30, 2020)

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Disappointing that adding palbociclib to Standard adjuvant aromatase inhibitor therapy for Stage II & III hormone receptor positive breast cancer failed to improve overall outcomes in this study. Adjuvant studies with ribociclib and abemociclib are awaited but this outcome from PALLAS dampens the prospects for major clinical benefits.

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