OncoMatch/Clinical Trials/NCT07011654
Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)
Is NCT07011654 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Sacituzumab govitecan and Naxitamab for metastatic triple-negative breast cancer.
Treatment: Sacituzumab govitecan · Naxitamab — This phase I/II trial tests the safety, best dose, and effectiveness of naxitamab in combination with sacituzumab govitecan in treating patients with triple-negative breast cancer (TNBC) that has spread from where it first started (primary site) to other places in the body (metastatic).
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 ≤10% expression (≤10%)
Estrogen receptor [ER] ≤10%
Required: PR (PGR) ≤10% expression (≤10%)
Progesterone receptor [PgR] ≤10%
Required: HER2 (ERBB2) HER2-negative as per ASCO/CAP guidelines (negative)
HER2-negative as per ASCO/CAP guidelines
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic chemotherapy — metastatic
Received at least 1 prior line of systemic chemotherapy for metastatic TNBC and/or meet criteria to receive sacituzumab govitecan as standard of care
Cannot have received: anti-GD2 antibody
Have previously received treatment with an anti-GD2 antibody
Cannot have received: TROP2-targeting antibody drug conjugate
Exception: Participants who have received TROP2-targeting antibody drug conjugates in the neoadjuvant setting or adjuvant setting are eligible if at least 6 months have elapsed since the last dose
Prior treatment with TROP2-targeting antibody drug conjugates in the metastatic setting. Participants who have received TROP2-targeting antibody drug conjugates in the neoadjuvant setting or adjuvant setting are eligible if at least 6 months have elapsed since the last dose of TROP2-targeting antibody drug conjugate.
Lab requirements
Blood counts
Adequate organ and marrow function as defined below
Kidney function
Adequate organ and marrow function as defined below
Liver function
Adequate organ and marrow function as defined below
Adequate organ and marrow function as defined below
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Texas M. D. Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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