Phase II Study of Pembrolizumab and Ablative Radiotherapy With or Without Olaparib in Metastatic Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancers : Initial Test Cohorts of a Platform Trial to Sequentially Investigate Immunotherapy Combinations for the Augmentation of Immune Responses

Summary

The purpose of this study is to find out whether adding pembrolizumab, with or without olaparib, to standard radiation therapy is a safe and effective treatment for metastatic breast cancer, , and to see whether the study treatment is better than, the same as, or worse than the usual approach (radiation therapy alone).

Eligibility

Age range

18+ years

Sex

Female

Healthy volunteers

No

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.

Locations (7)