PATINA: A randomized open label phase III trial to evaluate the efficacy and safety of palbociclib anti HER2 therapy endocrine therapy vs anti HER2 therapy endocrine therapy after induction treatment for hormone receptor positive, HER2 positive metastatic breast cancer

Otto Metzger-Filho; Sumithra Mandrekar; Sibylle Loibl; Eva Ciruelos; Luca Gianni; Elgene Lim; Kathy Miller; Cynthia Huang; Maria Koehler; Prue Francis; Pinuccia Valagussa; Shom Goel; Aleix Prat; Matthew Goetz; Sherene Loi; Ian Krop; Lisa Carey; Jane Lanzillotti; Eric Winer; Debu Tripathy; Angela DeMichele

Conference Proceedings

PATINA: A randomized open label phase III trial to evaluate the efficacy and safety of palbociclib anti HER2 therapy endocrine therapy vs anti HER2 therapy endocrine therapy after induction treatment for hormone receptor positive, HER2 positive metastatic breast cancer

Otto Metzger-Filho, Sumithra Mandrekar, Sibylle Loibl, Eva Ciruelos, Luca Gianni, Elgene Lim, Kathy Miller, Cynthia Huang, Maria Koehler, Prue Francis, Pinuccia Valagussa, Shom Goel, Aleix Prat, Matthew Goetz, Sherene Loi, Ian Krop, Lisa Carey, Jane Lanzillotti, Eric Winer, Debu Tripathy Show all

CANCER RESEARCH | AMER ASSOC CANCER RESEARCH | Published : 2018

DOI: 10.1158/1538-7445.sabcs17-ot3-05-07

Abstract

Abstract Background Pre-clinical data and initial results from clinical studies point to the added benefit of CDK4/6 inhibition when combined with anti-HER2 tx. The current study is designed to evaluate the added benefit of palbociclib when given in combination with anti-HER2 and endocrine tx maintenance in the 1st†line setting of metastatic HER2+HR+ breast cancer. Trial design PATINA is an international, open-label, pivotal Phase III study. Primary objective is to demonstrate that the combination of palbociclib with anti-HER2 plus endocrine tx is superior to anti-HER2 plus endocrine tx in prolonging PFS. Sample size is 496 pts. The..

View full abstract