Active — Not RecruitingPhase 2

A Study of Olaparib and Pembrolizumab in People With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer

United States23 participantsStarted 2022-01-31

Plain-language summary

This study will test any good and bad effects of combining the study drugs pembrolizumab and olaparib, given before the standard surgical procedure, to treat TNBC or HR+ HER2- breast cancers. The study drugs could shrink cancer, but they could also cause side effects. The study researchers want to find out whether the study drugs will shrink the cancer by a certain percentage compared with its current size, which may improve the outcome of surgery.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. TNBC (ER/PgR negativity will be defined using IHC per ASCO/CAP criteria/HER2-negativity will be defined using ISH or IHC assays per ASCO/CAP criteria) OR
✓. Hormone receptor-positive, HER2-negative breast cancer defined as per ASCO/CAP criteria
✓. Not a woman of childbearing potential (WOCBP) as defined by institutional guidelines OR
✓. A WOCBP who agrees to follow the contraceptive guidance starting at the time of informed consent, during the treatment period and for at least 120 days after the last dose of study treatment (pembrolizumab, olaparib) according to local standard of care.

What they're measuring

pathologically negative MRI-guided biopsy

Timeframe: 12 weeks

Trial details

NCT IDNCT05203445

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01

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