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Poster display session

4434 - SOLTI-1303 PATRICIA: A Phase II study of palbociclib and trastuzumab (with or without letrozole in ER+) in previously trastuzumab-pretreated, postmenopausal patients with HER2-positive metastatic breast cancer.

Date

11 Sep 2017

Session

Poster display session

Presenters

Patricia Villagrasa Gonzalez

Citation

Annals of Oncology (2017) 28 (suppl_5): v74-v108. 10.1093/annonc/mdx365

Authors

P. Villagrasa Gonzalez1, A. Prat2, M. Oliveira3, L. de la Pena4, X. Gonzalez5, J. Cortes Castan6, J. Rios7, J. Vázquez8, N. Martínez Jañez9, A. Perelló Martorell10, I. Garau11, E. Martinez de Dueñas12, S. Morales13, M. Melé14, B. Bermejo De Las Heras15, E. Ciruelos16

Author affiliations

  • 1 Scientific Department, SOLTI Breast Cancer Research Group, 08008 - Barcelona/ES
  • 2 Medical Oncology  , Hospital Clínic de Barcelona  , 8036 - Barcelona/ES
  • 3 Medical Oncology  , Vall d`Hebron University Hospital Institut d'Oncologia, 08035 - Barcelona/ES
  • 4 Scientific Department, SOLTI Breast Cancer Research Group, Barcelona/ES
  • 5 Medical Oncology  , Hospital Universitario Quirón Dexeus, 08028 - Barcelona/ES
  • 6 Oncology Service, Hospital Universitario Ramon y Cajal, 28031 - Madrid/ES
  • 7 Medical Statistics, Hospital Clinic Barcelona, Madrid/ES
  • 8 Medical Oncology  , SOLTI Breast Cancer Research Group, 08008 - Barcelona/ES
  • 9 Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid/ES
  • 10 Medical Oncology, Hospital Son Espases, Palma de Mallorca/ES
  • 11 Medical Oncology  , Hospital de Son Llàtzer, Palma de Mallorca/ES
  • 12 Medical Oncology, Hospital Provincial de Castellón, Castellon/ES
  • 13 Medical Oncology  , Hospital Universitario Arnau de Vilanova, Lleida/ES
  • 14 Medical Oncology  , Hospital Universitario Sant Joan de Reus, Reus/ES
  • 15 Medical Oncology  , Hospital Clinico Universitario de Valencia, 46010 - Valencia/ES
  • 16 Medical Oncology  , University Hospital 12 De Octubre, 28041 - Madrid/ES
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Resources

Abstract 4434

Background

Despite the high efficacy of anti-HER2 agents, HER2+ metastatic breast cancer remains incurable and in need of additional therapeutic options. Persistent activation of the cyclin D1/CDK4 axis has been identified as a mediator of resistance to anti-HER2 therapy but clinical data of the benefit of CDK4/6 inhibitors in combination with trastuzumab is lacking. PATRICIA is a Simon 2-Stage study to evaluate the efficacy of combining trastuzumab plus palbociclib, with or without letrozole, assessed by progression-free survival (PFS) in pretreated HER2-positive patients.

Trial design

Postmenopausal HER2-positive patients treated with 2-4 prior systemic anticancer treatment lines that must involve trastuzumab or another anti-HER2 treatment in the metastatic setting are included in three cohorts: A: HR-negative, receiving trastuzumab and palbociclib; B1: HR-positive, receiving trastuzumab and palbociclib; B2: HR-positive, receiving trastuzumab, palbociclib and letrozole. Palbociclib is administered at 200 mg/day for 14 days of 21-day cycles. Trastuzumab and letrozole are administered at usual doses. As these combinations have not been tested in phase I trials, we incorporated a 2 cycles-safety run-in phase with the first 6 patients of each regimen. The primary objective is to assess clinical efficacy measured as PFS at 6 months (PFS6). Assuming an increase of at least 20% in PFS6 by the addition of palbociclib +/- letrozole to trastuzumab, PFS6 should be ≥ 50% for a cohort to be successful and proceed to stage 2. According to this, it will be necessary to include 15 patients in each cohort in stage 1. In stage 2, each cohort may continue recruitment for up to 46 patients. Translational research searching for predictive biomarkers will be implemented. To date, 43 patients, 13 in A and 15 in each B cohort, have been included in 14 sites across Spain. An independent safety data committee was held twice during the study. The committee recommended that study continue enrollment as planned. The first stage efficacy analysis is intended for December 2017.

Clinical trial identification

NCT02448420

Legal entity responsible for the study

SOLTI Breast Cancer Research Group

Funding

Pfizer

Disclosure

All authors have declared no conflicts of interest.

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