A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

April 21, 2021

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Triple Negative Breast CancerTNBC - Triple-Negative Breast CancerBreast CancerMetastatic Breast Cancer
Interventions
DRUG

Pembrolizumab

Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks for 3 doses

DRUG

Olaparib

Olaparib will be administered twice daily continuously without breaks on a 21-day (3 week) cycle length, for a total of 2 cycles. Olaparib tablets will be administered bid (2 x 150 mg tablets twice daily; total 600 mg daily) on continuous days without interruption for 2 cycles. Each 3 week period constitutes one cycle.

RADIATION

Radiation

The dose of radiation will be 8-9 Gy x 3 fractions. Radiation therapy will begin on C1D2-7. For tumors that are too large for this schedule, an accomodation of 30 Gy in 6 Gy per fraction is allowed, a schedule commonly used at MSK.

Trial Locations (7)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York

10604

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities), Uniondale

11725

RECRUITING

Memorial Sloan Kettering Commack (Limited Protocol Activities), Commack

07920

RECRUITING

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER