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NCT06764940 · ClinicalTrials.gov registry record · Phase 2
A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases
A Phase 2 study of HER2-negative Breast Cancer Patients With Brain Metastases, sponsored by Biostar Pharma.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 17
- Study locations
NCT06764940: Recruiting Phase 2 study of HER2-negative Breast Cancer Patients With Brain Metastases, sponsored by Biostar Pharma.
NCT06764940 is a Phase 2 study of HER2-negative Breast Cancer Patients With Brain Metastases that is actively recruiting participants, run by Biostar Pharma. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). The trial reports 17 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06764940, a Phase 2 study of HER2-negative Breast Cancer Patients With Brain Metastases, is actively recruiting participants, sponsored by Biostar Pharma.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 17
- Study locations
Study Summary
This study is a multicenter, two-stage clinical trial to evaluate the efficacy and safety of utidelone in combination with capecitabine in patients with HER2-negative breast cancer with brain metastases. Patients will be enrolled to receive treatment of utidelone alone or in combination with capecitabine. The objectives both in stage I and stage II are to evaluate the intracranial and systemic efficacy and safety of utdelone plus capecitabine for the treatment of HER2-negative breast cancer patients with brain metastases.
Conditions Studied
Interventions
- DRUG Utidelone
- DRUG Utidelone in combination with capecitabine
Study Locations (17)
California
- City of Hope--Duarte - Duarte
- Cancer & Blood Research Center, LLC - Los Alamitos
- Univ. of California Los Angeles - Los Angeles
- FOMAT Medical Research (Network) - Oxnard
- Scripps Health - San Diego
Texas
- MD Anderson Cancer Center - Houston
- Community Clinical Trials - Kingwood
- Tranquil Clinical Research - Webster
Florida
- Biosresearch Partner - Hialeah
- D&H Cancer Research Center - Margate
Colorado
- University Of Colorado Hospital - Anschutz Cancer Pavilion - Aurora
Georgia
- Augusta University - Augusta
Illinois
- Robert H. Lurie Comprehensive Cancer Center Northwestern University - Chicago
Maryland
- The Johns Hopkins Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine - Baltimore
Michigan
- Profound Research LLC - Farmington Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-07-14 |
| Est. Completion | 2027-07-15 |
| Phase | Phase 2 |
What NCT06764940 shows while recruiting
NCT06764940 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 1 condition, with HER2-negative Breast Cancer Patients With Brain Metastases appearing as the primary indexed condition, and to 2 interventions - of which Utidelone is the first listed.
NCT06764940 lists 17 locations in 10 states (California, Texas, Florida).
Frequently Asked Questions
What is clinical trial NCT06764940 about?
NCT06764940 is a clinical study titled "A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases". This study is a multicenter, two-stage clinical trial to evaluate the efficacy and safety of utidelone in combination with capecitabine in patients with HER2-negative breast cancer with brain metastases. Patients will be enrolled to receive treatment of utidelone alone or in combination with capecit...
What is the current status of trial NCT06764940?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2025-07-14. Estimated completion is 2027-07-15.
What conditions does trial NCT06764940 study?
This clinical trial studies the following conditions: HER2-negative Breast Cancer Patients With Brain Metastases.
What interventions are being tested in trial NCT06764940?
The interventions under investigation include: Utidelone (DRUG), Utidelone in combination with capecitabine (DRUG).
Who is sponsoring clinical trial NCT06764940?
This trial is sponsored by Biostar Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06764940 being conducted?
This trial has 17 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06764940's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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