1. Olaparib plus trastuzumab in HER2-positive advanced breast cancer patients with germline BRCA1/2 mutations: The OPHELIA phase 2 study
- Author
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José Enrique Alés-Martínez, Judith Balmaña, Pedro Sánchez-Rovira, Francisco Javier Salvador Bofill, Jose Ángel García Sáenz, Isabel Pimentel, Serafín Morales, María Fernández-Abad, Ainhara Lahuerta Martínez, Neus Ferrer, Pilar Zamora, Begoña Bermejo, Tamara Díaz-Redondo, María Helena López-Ceballos, María Galán, Jhudit Pérez-Escuredo, Laura Calabuig, Miguel Sampayo, José Manuel Pérez-Garcia, Javier Cortés, and Antonio Llombart-Cussac
- Subjects
HER2-Positive ,Advanced breast cancer ,BRCA mutation ,Olaparib ,Trastuzumab ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Purpose: To evaluate the efficacy and safety of the combination of olaparib plus trastuzumab in patients with HER2-positive advanced breast cancer (ABC) and germinal BRCA mutations (gBRCAm). Methods: OPHELIA (NCT03931551) was a single-arm, open-label, phase 2 clinical trial. Patients aged ≥18 years diagnosed with HER2-positive ABC with germinal deleterious mutations in BRCA1 or BRCA2 who had received at least one prior systemic regimen for advanced disease were enrolled. Patients received olaparib plus trastuzumab until disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was investigator-assessed clinical benefit rate for at least 24 weeks as per RECIST v.1.1. Key secondary endpoints included overall response rate (ORR) and safety profile. Results: A total of 68 pre-treated HER2-positive ABC patients were screened. Due to slow accrual the trial was stopped after enrolling 5 patients instead of the planned sample size of 20. Four patients achieved clinical benefit (80.0 %, 95 % CI; 28.4–99.5, p
- Published
- 2024
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