Trials / Recruiting
RecruitingNCT04683679
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
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Triple Negative Breast Cancer
- TNBC - Triple-Negative Breast Cancer
- Breast Cancer
- Metastatic Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-04-21
- Primary completion
- 2027-01-01
- Completion
- 2027-01-01
- First posted
- 2020-12-24
- Last updated
- 2026-02-17
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04683679. Inclusion in this directory is not an endorsement.