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Chemo-free BRCA-targeted Neoadjuvant Strategy

NCT05209529 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-02-23

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

olaparib

olaparib 300 mg per os BID

DRUG

Durvalumab

durvalumab 1500 mg IV Q4 weeks

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Etienne Brain · Institut Curie Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2028-09-06
Completion
2030-07-18

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05209529 on ClinicalTrials.gov