Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Yuan Yuan
Study ID
NCT03025035
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab IV solution administered on Day 1 of each 3-week cycle
  • Olaparib — DRUG
    Olaparib administered orally twice a day

Study Details

This trial will evaluate the use of immunotherapy and PARP inhibition in a population with incurable advanced breast cancer associated with a germline BRCA mutation or HDR-defect. The main objective is to examine overall response rate of pembrolizumab (immunotherapy) in combination with Olaparib (PARP inhibitor) in advanced BRCA-mutated or Homology-directed repair (HDR)-defect breast cancer.

Key Dates

Start date
Sep 10, 2017
Status verified
Jan 2026
Primary completion
Oct 8, 2024
Completion
Nov 21, 2025

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + Olaparib
    This is an open-label, single-arm pilot study of pembrolizumab (study drug) in combination with Olaparib in 20 subjects with advanced BRCA mutation or HDR-defect associated breast cancer having progressed through at least a standard first line therapy.

Primary Outcome Measure

Overall Response Rate (ORR) Per RECIST1.1 [ Time Frame: Up to 2 Years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-

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Find similar trials in Los Angeles, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Cedars-Sinai Medical Center· Los Angeles, CA

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