OncoMatch

OncoMatch/Clinical Trials/NCT04230109

Sacituzumab Govitecan In TNBC

Is NCT04230109 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Sacituzumab Govitecan and Pembrolizumab for invasive breast cancer.

Phase 2RecruitingMassachusetts General HospitalNCT04230109Data as of May 2026

Treatment: Sacituzumab Govitecan · Pembrolizumab — This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC) The names of the study drugs involved in this study is: * Sacituzumab govitecan (SG) * Pembrolizumab (combination therapy with SG)

Check if I qualify

Extracted eligibility criteria

Cancer type

Breast Carcinoma

Triple-Negative Breast Cancer

Biomarker criteria

Required: ESR1 wild-type (negative)

biopsy proven ER negative (ER-)...ER, PR, and HER2 positivity would be determined per ASCO/CAP guidelines by institutional (local) assessment

Required: PR (PGR) wild-type (negative)

biopsy proven...PR negative (PR-)...ER, PR, and HER2 positivity would be determined per ASCO/CAP guidelines by institutional (local) assessment

Required: HER2 (ERBB2) wild-type (negative)

biopsy proven...HER2 negative (HER2-)...ER, PR, and HER2 positivity would be determined per ASCO/CAP guidelines by institutional (local) assessment

Disease stage

Excluded: Stage DISTANT METASTATIC DISEASE

Primary tumor (at least one lesion) 1 cm or greater measured by radiological imaging. Regional lymph node AJCC (v7) TNM stages N0-N2. If node positive, any primary tumor size is permissible. Absence of distant metastatic disease (AJCC TNM stage M0).

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy for any other malignancy

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥ 1,500 per mm3; Platelets ≥ 100,000 per mm3; Hemoglobin ≥9.0 g/dL; INR ≤1.5

Kidney function

Serum creatinine <1.5 mg/dL or creatinine clearance ≥50 mL/min

Liver function

ALT and AST <2.5 x ULN; Total bilirubin ≤1.5 x ULN or in patients with well-documented Gilbert's Syndrome direct bilirubin ≤1.5 x ULN.

Patient has adequate bone marrow and organ function as defined by the following laboratory values at screening: Absolute neutrophil count (ANC) ≥ 1,500 per mm3; Platelets ≥ 100,000 per mm3; Hemoglobin ≥9.0 g/dL; INR ≤1.5; Serum creatinine <1.5 mg/dL or creatinine clearance ≥50 mL/min; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x ULN. Total bilirubin ≤1.5 x ULN or in patients with well-documented Gilbert's Syndrome direct bilirubin ≤1.5 x ULN.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Beth Israel Deaconess Medical Center · Boston, Massachusetts
  • Dana Farber Cancer Institute · Boston, Massachusetts
  • Massachusetts General Hospital · Boston, Massachusetts
  • Massachusetts General Hospital - North Shore Cancer Center · Danvers, Massachusetts
  • Massachusetts General Hospital at Newton-Wellesley Hospital · Newton, Massachusetts

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify