RecruitingPhase 1Phase 2NCT07011654

Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)

Phase I/II Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)

Sponsor

M.D. Anderson Cancer Center

Enrollment

31 participants

Start Date

Sep 19, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Triple-negative Breast Cancer

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two targeted drugs — naxitamab (which targets a surface protein on cancer cells) and sacituzumab govitecan (an antibody-drug combination) — for patients with metastatic triple-negative breast cancer (TNBC), a form of breast cancer that is harder to treat because it does not respond to hormone therapies. **You may be eligible if...** - You are 18 or older - You have metastatic TNBC confirmed by biopsy (ER-negative, PR-negative, HER2-negative) - You are in good to reasonable physical condition (ECOG 0–2) - You have life expectancy of at least 3 months **You may NOT be eligible if...** - You have had more than a certain number of prior treatments for metastatic TNBC - You have brain metastases that are active or unstable - You have significant heart, liver, or bone marrow problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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