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NCT06238921 · ClinicalTrials.gov registry record · Phase 1
Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases
A Phase 1 study of Breast Cancer and Triple Negative Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT06238921: Recruiting Phase 1 study of Breast Cancer and Triple Negative Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT06238921 is a Phase 1 study of Breast Cancer and Triple Negative Breast Cancer that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 31 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06238921, a Phase 1 study of Breast Cancer and Triple Negative Breast Cancer, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase I/II Study to determine the safety and efficacy of Sacituzumab Govitecan and Zimberelimab with stereotactic radiation (SRS) in participants with metastatic triple negative breast cancer with brain metastases, compared to treatment with Sacituzumab Govitecan alone.
Primary Outcome
Neurologic Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5). A Neurologic Toxicity will be defined as any Grade 3 or higher toxicity that occurs during the Dose Limiting Toxicity evaluation period. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded from this definition. * Symptomatic radionecrosis, defined by surgical pathology or multidisciplinary evaluation. * G
Conditions Studied
Interventions
- DRUG Sacituzumab govitecan
- DRUG Zimberelimab
- RADIATION Stereotactic Radiation
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2024-12-19 |
| Est. Completion | 2027-02 |
| Phase | Phase 1 |
What NCT06238921 shows while recruiting
NCT06238921 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 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Sacituzumab govitecan is the first listed.
NCT06238921 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06238921 about?
NCT06238921 is a clinical study titled "Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases". This is a Phase I/II Study to determine the safety and efficacy of Sacituzumab Govitecan and Zimberelimab with stereotactic radiation (SRS) in participants with metastatic triple negative breast cancer with brain metastases, compared to treatment with Sacituzumab Govitecan alone.
What is the current status of trial NCT06238921?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2024-12-19. Estimated completion is 2027-02.
What conditions does trial NCT06238921 study?
This clinical trial studies the following conditions: Breast Cancer, Triple Negative Breast Cancer.
What interventions are being tested in trial NCT06238921?
The interventions under investigation include: Sacituzumab govitecan (DRUG), Zimberelimab (DRUG), Stereotactic Radiation (RADIATION).
Who is sponsoring clinical trial NCT06238921?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06238921 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06238921's enrollment target sits among peer trials
31 948th of 1224 higher than 271 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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