PHILADELPHIA, PA, June 27, 2026 — The U.S. Food and Drug Administration (FDA) has approved a new maintenance treatment option for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2–positive (HER2+) locally advanced or metastatic breast cancer based on the results of the phase 3 PATINA study. The FDA granted approval on June 24, 2026.
The approval is for palbociclib (Ibrance®) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy following induction treatment.
The PATINA trial (AFT-38, PrE0111, NCT02947685) was a global academic collaboration in which PrECOG, LLC participated as a research partner. The randomized phase 3 trial enrolled 518 patients at 109 clinical sites in the United States, Europe, Australia, and New Zealand.
PATINA evaluated whether adding palbociclib, a CDK4/6 inhibitor, to anti-HER2 and endocrine therapy after four to eight cycles of induction chemotherapy could delay disease progression. The study demonstrated a more than 15-month improvement in median progression-free survival (PFS), from 29.1 to 44.3 months, with the addition of palbociclib to anti-HER2 and endocrine therapy in this patient population. Final results were published in the New England Journal of Medicine in January 2026.
“The PATINA study exemplifies the power of global academic collaboration to answer clinically important questions that directly impact patient care,” said Peter J. O’Dwyer, MD, chief executive officer and chair of PrECOG. “We are proud to have partnered with international research groups on a study that has led to a new first-line maintenance treatment option in this distinct subset of metastatic breast cancer.”
Alliance Foundation Trials, LLC, led PATINA as the global sponsor, in partnership with Breast Cancer Trials (Australia and New Zealand), Fondazione Michelangelo, GBG Forschungs GmbH, PrECOG, SOLTI, and Unicancer. Pfizer Inc. funded the study.
About PrECOG
PrECOG, LLC is a cancer research organization that designs and conducts innovative oncology studies through industry partnerships and research networks. PrECOG focuses on trials that align with the scientific mission and research goals of the ECOG-ACRIN Cancer Research Group.