Active — Not RecruitingPhase 2

Comprehensive Analysis of Predictors of the Treatment With Pembrolizumab and Olaparib in Patients With Unresectable or Metastatic HER2 Negative Breast Cancer and a Deleterious Germline Mutation or a Homologous Recombination Deficiency (COMPRENDO

Germany11 participantsStarted 2022-07-30

Plain-language summary

This study will examine the combination of pembrolizumab and olaparib in three populations. * Cohort 1: aBC patients with a germline mutation in BRCA1 or BRCA2, * cohort 2: aBC patients with a germline mutation in one of the moderate penetrance homologous repair genes (ATM, BARD1, CHEK2, FANCC, PALB2, RAD51C, RAD51D, SLX4, XRCC2), and * cohort 3: aBC patients with a HRD as assessed by whole genome sequencing.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. The participant must provide written informed consent.
✓. Male/Female participants must be ≥18 years of age at the day of signing informed consent and must be willing to comply with the study specific procedures.
✓. Histologically confirmed metastatic or advanced, unresectable HER2 negative (0, 1+ by IHC or ISH amplified \< 2.0) breast cancer which is not eligible for curative treatment.
✓. Cohort 1: Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious (known or predicted to be detrimental/lead to loss of function) irrespective of HRD status.
✓. Cohort 2: Germline mutation in ATM, BARD1, CHEK2, FANCC, PALB2, RAD51C, RAD51D, SLX4, XRCC2 that is predicted to be deleterious (known or predicted to be detrimental/lead to loss of function) irrespective of HRD status.
✓. Cohort 3: High HRD status and no germline mutation in one of the above mentioned genes of cohort 1 or cohort 2.
✓. Cohort 3: Availability of FFPE tumor material for further validation of HRD status (bridging tests).
✓. Cohorts 2 and 3: Patients must have been treated with first line chemotherapy, if this chemotherapy is standard of care in this therapy situation.

Exclusion criteria

What they're measuring

Efficacy of the combination of pembrolizumab and olaparib via overall response rate

Timeframe: baseline up to 27 weeks

Trial details

NCT IDNCT05033756

SponsorInstitut fuer Frauengesundheit

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01

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