Chemo-free BRCA-targeted Neoadjuvant Strategy

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT05209529
Phase
PHASE2
Status
Withdrawn

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • olaparib — DRUG
    olaparib 300 mg per os BID
  • Durvalumab — DRUG
    durvalumab 1500 mg IV Q4 weeks

Study Details

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.

Key Dates

Start date
Feb 1, 2024
Status verified
Feb 2024
Primary completion
Sep 6, 2028
Completion
Jul 18, 2030

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib
    Olaparib treatment for a total of 16 weeks
  • Experimental: Olaparib and durvalumab
    Olaparib and durvalumab treatment for a total of 16 weeks

Primary Outcome Measure

rate of pathological complete response (pCR) at the time of surgery [ Time Frame: 5 years from first patient in ]

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