CompletedPhase 2

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

United States14 participantsStarted 2017-09-10

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50
✓. radiation-induced oophorectomy with last menses \>1 year ago
✓. chemotherapy-induced menopause with \>1 year interval since last menses
✓. surgical sterilization (bilateral oophorectomy or hysterectomy)

Exclusion criteria

✕. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 3 weeks prior to study Day 1.
✕. Subjects must have recovered (i.e., ≤ Grade 1 or at baseline) from any adverse events due to a previously administered agent. Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
✕. If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
✕. Subjects with ER+/PR+ disease may be given endocrine therapy.
✕. Subjects with HER2+ disease will be required to discontinue trastuzumab (Herceptin).

What they're measuring

Overall Response Rate (ORR) Per RECIST1.1

Timeframe: Up to 2 Years

Trial details

NCT IDNCT03025035

SponsorYuan Yuan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-08

Results submitted2025-04-29

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