OncoMatch/Clinical Trials/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
Is NCT04683679 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Olaparib for triple negative breast cancer.
Treatment: Pembrolizumab · Olaparib — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression 1-100% (1-100%)
ER+ breast cancer, defined as ER 1-100% and HER-2/neu 0-1+ by IHC or FISH-negative
Required: HER2 (ERBB2) 0-1+ (0-1+ by IHC or FISH-negative)
HER-2/neu 0-1+ by IHC or FISH-negative
Required: ESR1 expression <5% (<5%)
TNBC (defined as ER <5%, PR <5%, HER- 2-neu 0-1+ by IHC or FISH-negative or per MD discretion)
Required: PR (PGR) expression <5% (<5%)
TNBC (defined as ER <5%, PR <5%, HER- 2-neu 0-1+ by IHC or FISH-negative or per MD discretion)
Required: HER2 (ERBB2) 0-1+ (0-1+ by IHC or FISH-negative)
TNBC (defined as ER <5%, PR <5%, HER- 2-neu 0-1+ by IHC or FISH-negative or per MD discretion)
Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)
PD-L1 status is required or archival tissue must be readily available for testing during screening if status was not previously determined.
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: ≤ 3 prior lines for inoperable/recurrent or metastatic TNBC; any number allowed for mER+BC
No more than 3 prior lines of systemic therapy ... for inoperable/recurrent or metastatic disease in the TNBC cohort. Any number of prior lines of treatment for mER+BC are allowed.
Lab requirements
Blood counts
Absolute neutrophil count (ANC): ≥ 1500/µL; Platelets: ≥ 100,000/µL; Hemoglobin: ≥ 9.0 g/dL with no blood transfusion in the past 28 days
Kidney function
Creatinine: 1.5 x ULN OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≥ 51 mL/min
Liver function
Total bilirubin: ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels >1.5 x ULN; AST (SGOT) and ALT (SGPT): ≤ 2.5 x ULN (≤ 5 x ULN for participants with liver metastases)
Adequate organ function as defined in the following table (Table 2)...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Commack (Limited Protocol Activities) · Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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