OncoMatch/Clinical Trials/NCT04468061
Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC
Is NCT04468061 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Sacituzumab Govitecan and Pembrolizumab for breast cancer.
Treatment: Sacituzumab Govitecan · Pembrolizumab — This research study involves testing the safety and efficacy of an investigational intervention for patients with triple-negative breast cancer (TNBC) that has spread, or metastasized, to other parts the body and is PD-L1-negative. The names of the study interventions involved in this study are: * Sacituzumab govitecan (Trodelvy™;IMMU-132) * Pembrolizumab (Keytruda®; MK-3475)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: ESR1 expression ≤ 5% (≤ 5% by IHC)
Estrogen-receptor and progesterone-receptor expression both ≤ 5% by immunohistochemistry (IHC)
Required: PR (PGR) expression ≤ 5% (≤ 5% by IHC)
Estrogen-receptor and progesterone-receptor expression both ≤ 5% by immunohistochemistry (IHC)
Required: HER2 (ERBB2) negative (HER2-negative status as determined by the current ASCO/CAP guidelines)
HER2-negative status as determined by the current ASCO/CAP guidelines
Required: PD-L1 (CD274) negative (PD-L1-negative metastatic breast cancer defined as less than 1% expression of PD-L1 on tumor-infiltrating immune cells (IC) by the PD-L1 IHC SP142 assay or a Combined Positive Score (CPS) less than 10 by the PD-L1 IHC 22C3 assay)
Participants must have PD-L1-negative metastatic breast cancer defined as less than 1% expression of PD-L1 on tumor-infiltrating immune cells (IC) by the PD-L1 IHC SP142 assay or a Combined Positive Score (CPS) less than 10 by the PD-L1 IHC 22C3 assay
Excluded: UGT1A1 *28 homozygosity
Known history of UDP-glucuronosyltransferase 1A1 (UGT1A1) *28 allele homozygosity, which is associated with increased risk for neutropenia and diarrhea related to irinotecan
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: no prior chemotherapy for metastatic breast cancer; prior chemotherapy in other settings allowed if discontinued ≥ 28 days before study treatment
Participants must have received no prior chemotherapy for metastatic breast cancer and must have discontinued all chemotherapy at least 28 days prior to study treatment initiation
Cannot have received: biologic therapy
Exception: no prior biologic therapy for metastatic breast cancer; prior biologic therapy in other settings allowed if discontinued ≥ 28 days before study treatment
Patients must have received no prior biologic therapy for metastatic breast cancer and discontinued all biologic therapy at least 28 days prior to study treatment initiation
Cannot have received: anti-PD-1 therapy
Prior therapy with any anti-PD-1, PD-L1, or PD-L2 agent
Cannot have received: topoisomerase I-containing antibody drug conjugate (sacituzumab govitecan, irinotecan)
Prior therapy with sacituzumab govitecan (IMMU-132). Prior therapy with irinotecan or topoisomerase I-containing antibody drug conjugates at any time for early stage or metastatic disease
Lab requirements
Blood counts
Absolute neutrophil count ≥1,000/mcL; Platelets ≥100,000/mcL; Hemoglobin ≥ 9.0 g/dl; INR/PT/aPTT ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is in therapeutic range of anticoagulant
Kidney function
Serum creatinine ≤1.5 × institutional ULN OR creatinine clearance ≥ 30 mL/min/ 1.73m2 for participants with creatinine levels above institutional ULN
Liver function
Total bilirubin ≤1.5 × institutional ULN (or ≤2.0 x ULN in patients with documented Gilbert's Syndrome); AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN or ≤5 × institutional ULN for participants with documented liver metastases
Participants must have normal organ and marrow function as defined below: Absolute neutrophil count ≥1,000/mcL; Platelets ≥100,000/mcL; Hemoglobin ≥ 9.0 g/dl; INR/PT/aPTT ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is in therapeutic range of anticoagulant; Total bilirubin ≤1.5 × institutional upper limit of normal (ULN)(or ≤2.0 x ULN in patients with documented Gilbert's Syndrome); AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN or ≤5 × institutional ULN for participants with documented liver metastases; Serum creatinine ≤1.5 × institutional ULN OR creatinine clearance ≥ 30 mL/min/ 1.73m2 for participants with creatinine levels above institutional ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stamford Hospital · Stamford, Connecticut
- Miami Cancer Institute at Baptist Health (Kendall) · Miami, Florida
- Miami Cancer Institute at Baptist Health · Plantation, Florida
- University of Chicago Medical Center · Chicago, Illinois
- Eastern Maine Medical Center · Brewer, Maine
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04468061 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.
Does this trial require ESR1?
Yes, ESR1 expression ≤ 5% is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression ≤ 5% is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Are patients with UGT1A1 alterations eligible?
No. UGT1A1 *28 homozygosity 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