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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

July 30, 2022

Primary Completion Date

January 31, 2025

Study Completion Date

February 28, 2026

Conditions
Malignant Neoplasm of BreastBreast Cancer
Interventions
DRUG

Pembrolizumab Injection [Keytruda]

The planned dose of pembrolizumab for this study is 200 mg every 3 weeks (Q3W). Based on the totality of data generated in the Keytruda development program, 200 mg Q3W is the appropriate dose of pembrolizumab for adults across all indications and regardless of tumor type.

DRUG

Olaparib Oral Tablet [Lynparza]

All patients will receive olaparib treatment as an addition to pembrolizumab. The dose of olaparib used in this study is 300 mg twice daily (total daily dose of 600 mg) which is the currently approved dose.

Trial Locations (6)

13125

Helios-Klinikum Berlin-Buch, Berlin

40225

University Hospital Düsseldorf, Düsseldorf

46236

Marienhospital Bottrop, Bottrop

72076

Department of Gynecology, Tübingen University Hospital, Tübingen

89075

University Hospital Ulm, Ulm

91054

Department of Gynecology and Obstetrics, Erlangen University Hospital, Erlangen

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Institut fuer Frauengesundheit

OTHER