NCT05209529

Chemo-free BRCA-targeted Neoadjuvant Strategy

Neoadjuvant Olaparib and Durvalumab for Patients With BRCA-associated Triple Negative Breast Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter randomized phase ll clinical trial to evaluate the pathological complete response (pCR) in the tumour burden (primary and lymph nodes) with olaparib alone or in the olaparib and durvalumab arm in TNBC patients candidate for neoadjuvant strategy showing a t/gBRCAmut or BRCAness/HRD profile.

Detailed description

Eligible patients will be registered for central testing of BRCA mutatinal status and HRD/BRCAness profile with central review of ER, PgR, TILs and PD-L1. Eligible patients will be randomly assigned to either olparib or olaparib and durvalumab (=neoadjuvant treatment) in a 1:1 ratio. The treatment duration in both arms will last 16 weeks and both treatments are considered as experimental treatments in this study. After completion of neoadjuvant systemic treatment, patients will undergo surgery and followed-up for 2 years after investigational drug discontinuation. After surgery, adjuvant treatment will be left at the investigator's decision.

Conditions

• TNBC - Triple-Negative Breast Cancer
• BRCA1 Mutation
• BRCA2 Mutation

Interventions

Type	Name	Description
DRUG	olaparib	olaparib 300 mg per os BID
DRUG	Durvalumab	durvalumab 1500 mg IV Q4 weeks

Timeline

• Start date: 2024-02-01
• Primary completion: 2028-09-06
• Completion: 2030-07-18
• First posted: 2022-01-26
• Last updated: 2024-02-23