Abstract OT3-05-07: 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
Authors: Metzger-Filho O , Mandrekar S , Loibl S , Ciruelos E , Gianni L , Lim E , Miller K , Huang C , Koehler M , Francis P , Valagussa P , Goel S , Prat A , Goetz M , Loi S , Krop I , Carey L , Lanzillotti J , Winer E , Tripathy D , DeMichele A 
Published: February 2018

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 study starts after completion of 6-8 cycles of chemotherapy-containing anti-HER2 tx for metastatic breast cancer in the 1st line setting. Pts are eligible provided they are without evidence of disease progression by local assessment (i.e. CR, PR or SD). To account for the need for less intense tx regimens for a subset of pts diagnosed with HER2+ER+ disease, clinicians may recommend the combination of trastuzumab with either a taxane or vinorelbine prior to study initiation. Clinicians might also choose a non-pertuzumab option for pts previously treated with pertuzumab in the neo(adjuvant) setting. Secondary objectives include measures of tumor control (OR, CBR, DOR), OS, safety and QOL. The translational science main objective is to compare PFS estimates according to PIK3CA mutation status assessed by cfDNA analysis. Endocrine tx options are AI or fulvestrant. Premenopausal pts must receive ovarian suppression. The study has a 90% power to detect a hazard ratio of 0.667 in favor of the palbociclib arm. Pts approached to participate in AFT-38 will be asked to indicate on the informed consent forms whether remaining biospecimens and clinical data from the control arm of the study can be shared with the Mastering Breast Cancer (MBC) Initiative. The overarching purpose of the MBC is to create a mechanism for understanding the natural history of metastatic breast cancer by cataloguing longitudinally studied tumor-specific markers and treatment effects.
ClinicalTrials.gov Identifier: NCT02947685
Citation Format: Metzger-Filho O, Mandrekar S, Loibl S, Ciruelos E, Gianni L, Lim E, Miller K, Huang C, Koehler M, Francis P, Valagussa P, Goel S, Prat A, Goetz M, Loi S, Krop I, Carey L, Lanzillotti J, Winer E, Tripathy D, DeMichele A. 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 [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr OT3-05-07.