Predicting Olaparib Sensitivity in Patients With Unresectable Locally Advanced/Metastatic HER2-negative Breast Cancer.

Sponsor
SOLTI Breast Cancer Research Group
Study ID
NCT05340413
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The primary objetive is to assess the capacity of the RAD51-foci score to predict the efficacy of olaparib in BRCA1/2, PALB2 or RAD51C/D mut advanced breast cancer (cohort 1). The investigators propose the hypothesis that the RAD51-foci low tumours determined by immunofluorescence using RAD51 assay in patients with BRCA1/2, PALB2 \& RAD51C/D mutation (cohort 1) predicts response to olaparib. Furthermore, The investigators posit that the determination of RAD51-foci score in tumour identifies patients who can benefit from olaparib beyond mutations in these 5 genes. This hypothesis will be tested in cohort 2.

Key Dates

Start date
Mar 25, 2022
Status verified
Mar 2026
Primary completion
Feb 3, 2025
Completion
Feb 3, 2025

Study Design

Enrollment
65 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cohort 1
    HER2-negative ABC with documented germline or somatic mutation in BRCA1, BRCA2, PALB2, RAD51C or RAD51D that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function). Patients with BRCA1, BRCA2, PALB2, RAD51C or RAD51D mutations that are considered to be non-detrimental (e.g., "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favor polymorphism" or "benign polymorphism," etc.) will not be eligible for this cohort.
  • Active Comparator: Cohort 2
    HER2-negative ABC with RAD51-foci low score in the most recent locally recurrence or biopsy from the metastatic context and without known or with negative germline or somatic mutations in BRCA1, BRCA2, PALB2, RAD51C or RAD51D predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function). Mutation status will be assessed in, at least, olaparib responding patients in this subgroup.

Primary Outcome Measure

Capacity of the RAD51-foci score to predict the efficacy of olaparib in BRCA1/2, PALB2 or RAD51C/D mut advanced breast cancer (cohort 1) [ Time Frame: 15 months ]

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