OncoMatch/Clinical Trials/NCT04230109
Sacituzumab Govitecan In TNBC
Is NCT04230109 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Sacituzumab Govitecan and Pembrolizumab for invasive breast cancer.
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 qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
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
Cannot have received: systemic therapy for any malignancy
Exception: Concurrent endocrine therapy allowed in the adjuvant setting. Concurrent GnRH agonists allowed in any setting. Concurrent CDK4/6 inhibitor not allowed in any setting.
Participants currently receiving systemic therapy for any malignancy or having received systemic therapy for a malignancy in the preceding 3 years.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1,500 per mm3; Platelets ≥ 100,000 per mm3; Hemoglobin ≥9.0 g/dL; PT-INR ≤1.5 x institutional ULN unless participant is receiving anticoagulant therapy as long as PT or aPPT is within therapeutic range of intended use of anticoagulants (for patients receiving pembrolizumab only)
Kidney function
Serum creatinine <1.5 mg/dL or creatinine clearance ≥50 mL/min (via the Cockcroft-Gault formula) for participants with creatinine levels above institutional upper limit of normal (ULN)
Liver function
bilirubin ≤ 1.5 ULN, AST and ALT ≤ 2.5 X ULN and serum albumin > 3 g/dL
Patient has adequate bone marrow and organ function as defined by the following laboratory values at screening
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 →Frequently asked questions
Is NCT04230109 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
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