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Clinical Trial
. 2020 Nov 15;26(22):5820-5829.
doi: 10.1158/1078-0432.CCR-20-0844. Epub 2020 Sep 16.

Palbociclib and Trastuzumab in HER2-Positive Advanced Breast Cancer: Results from the Phase II SOLTI-1303 PATRICIA Trial

Eva Ciruelos  1   2   3 , Patricia Villagrasa  3 , Tomás Pascual  3   4   5   6 , Mafalda Oliveira  3   7   8 , Sonia Pernas  3   9 , Laia Paré  3   4 , Santiago Escrivá-de-Romaní  7 , Luis Manso  10 , Barbara Adamo  4   5 , Eduardo Martínez  11 , Javier Cortés  12 , Silvia Vazquez  9 , Antonia Perelló  13 , Isabel Garau  14 , Mireia Melé  15 , Noelia Martínez  16 , Alvaro Montaño  17 , Begoña Bermejo  18 , Serafin Morales  19 , María J Echarri  20 , Estela Vega  2 , Blanca González-Farré  4   5 , Débora Martínez  4 , Patricia Galván  4 , Jordi Canes  3 , Paolo Nuciforo  7   8 , Xavier Gonzalez  3   21   22 , Aleix Prat  23   4   5
Affiliations
Clinical Trial

Palbociclib and Trastuzumab in HER2-Positive Advanced Breast Cancer: Results from the Phase II SOLTI-1303 PATRICIA Trial

Eva Ciruelos et al. Clin Cancer Res. .

Abstract

Purpose: To assess palbociclib in combination with trastuzumab with or without endocrine therapy in patients with HER2-positive advanced breast cancer.

Patients and methods: PATRICIA is a prospective, open-label, multicenter phase II trial. Patients had received 2-4 prior lines of anti-HER2-based regimens. Treatment consisted of palbociclib 200 mg daily for 2 weeks and 1 week off plus trastuzumab. The study was based on a Simon two-stage design comprising three cohorts: estrogen receptor (ER)-negative (cohort A), ER-positive (cohort B1), and ER-positive with letrozole (cohort B2). ER-positive patients were randomized to cohorts B1 or B2. Primary endpoint was progression-free survival rate at 6 months (PFS6). Secondary objectives included safety and evaluation of the PAM50 intrinsic subtypes.

Results: Seventy-one patients were recruited (n = 15 in cohort A and 28 in each cohort B). The PFS6 rate in cohorts A, B1, and B2 was 33.3% (5/15), 42.8% (12/28), and 46.4% (13/28), respectively. Regarding safety, grade 1-2 and 3-4 toxicities occurred in 97.7% and 84.4% of patients, respectively. The most common grade 3-4 toxicities were neutropenia (66.4%) and thrombocytopenia (11.3%). Regarding PAM50, 59 (83.1%) tumors were profiled. Luminal disease defined by PAM50 was found independently associated with longer PFS compared with non-luminal disease (10.6 vs. 4.2 months median PFS; adjusted hazard ratio = 0.40; P = 0.003).

Conclusions: Palbociclib in combination with trastuzumab is safe and exhibits promising survival outcomes in trastuzumab pretreated ER-positive/HER2-positive advanced breast cancer with a PAM50 Luminal A or B subtype. The enrollment was stopped prematurely, and a new randomized cohort was opened in this population.

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