NCT04683679 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

Trial Parameters

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Brief 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 Criteria

Inclusion Criteria: * Female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of triple negative breast cancer or ER+/Her2 will be enrolled in this study. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 30 days prior to the date of allocation/randomization * Histologically or cytologically-confirmed TNBC (defined as ER \<5%, PR \<5%, HER- 2-neu 0-1+ by IHC or FISH-negative or per MD discretion). * Histologically of cytologically-confirmed ER+ breast cancer, defined as ER 1-100% and HER-2/neu 0-1+ by IHC or FISH-negative * Metastatic or recurrent TNBC. * Metastatic or recurrent ER+ breast cancer * For mTNBC patients, prior receipt of ICI with progression and/or PDL1-negative. PDL-1 status is not used to determine eligibility among mER+BC patients * Note: PDL1-status may be determined on tissues from either primary or mTNBC. Determinat

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