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Recruiting Phase 2 Interventional

A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases

ClinicalTrials.gov ID: NCT06764940

Public ClinicalTrials.gov record NCT06764940. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 14, 2026, 11:46 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients With Brain Metastases

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06764940
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Biostar Pharma, Inc.
Industry
Enrollment
120 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 13, 2025
Primary completion
Jan 14, 2027
Completion
Jul 14, 2027
Last update posted
Aug 20, 2026

2025 – 2027

United States locations

U.S. sites
12
U.S. states
8
U.S. cities
12
Facility City State ZIP Site status
City of Hope--Duarte Duarte California 91010 Recruiting
Univ. of California Los Angeles Los Angeles California 90095 Recruiting
Scripps Health San Diego California 92121 Recruiting
University Of Colorado Hospital - Anschutz Cancer Pavilion Aurora Colorado 80045 Recruiting
Augusta University Augusta Georgia 30912 Recruiting
Robert H. Lurie Comprehensive Cancer Center Northwestern University Chicago Illinois 60611 Recruiting
The Johns Hopkins Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine Baltimore Maryland 21287 Recruiting
Comprehensive Cancer Centers of Nevada Las Vegas Nevada 89169 Recruiting
Stony Brook Cancer Center Stony Brook New York 11794-7263 Recruiting
MD Anderson Cancer Center Houston Texas 77030 Recruiting
Community Clinical Trials Kingwood Texas 22751 Recruiting
Tranquil Clinical Research Webster Texas 77598 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06764940, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 20, 2026 · Synced Sep 14, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06764940 live on ClinicalTrials.gov.

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