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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.

Phase 1/2RecruitingM.D. Anderson Cancer CenterNCT07011654Data as of May 2026

Treatment: Sacituzumab govitecan · NaxitamabThis 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).

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Extracted 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

Min 1 prior line

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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