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NCT07011654 · ClinicalTrials.gov registry record · Phase 1
Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)
A Phase 1 study of Metastatic Triple-Negative Breast Cancer, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT07011654: Recruiting Phase 1 study of Metastatic Triple-Negative Breast Cancer, sponsored by M.D. Anderson Cancer Center.
NCT07011654 is a Phase 1 study of Metastatic Triple-Negative Breast Cancer that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 31 participants, below the 86-participant average among 5 other Metastatic Triple-Negative Breast Cancer trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07011654, a Phase 1 study of Metastatic Triple-Negative Breast Cancer, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Conditions Studied
Interventions
- DRUG Sacituzumab govitecan
- DRUG Naxitamab
Study Locations (1)
Texas
- The University of Texas M. D. Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2025-09-19 |
| Est. Completion | 2030-07-01 |
| Phase | Phase 1 |
What NCT07011654 shows while recruiting
NCT07011654 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 86-participant average among 5 other Metastatic Triple-Negative Breast Cancer trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Metastatic Triple-Negative Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Sacituzumab govitecan is the first listed.
NCT07011654 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT07011654 about?
NCT07011654 is a clinical study titled "Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)". 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).
What is the current status of trial NCT07011654?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2025-09-19. Estimated completion is 2030-07-01.
What conditions does trial NCT07011654 study?
This clinical trial studies the following conditions: Metastatic Triple-Negative Breast Cancer.
What interventions are being tested in trial NCT07011654?
The interventions under investigation include: Sacituzumab govitecan (DRUG), Naxitamab (DRUG).
Who is sponsoring clinical trial NCT07011654?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07011654 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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