RecruitingPhase 2NCT06764940

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

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

Sponsor

Biostar Pharma, Inc.

Enrollment

120 participants

Start Date

Jul 14, 2025

Study Type

INTERVENTIONAL

Conditions

HER2-negative Breast Cancer Patients With Brain Metastases

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug combination — utidelone plus capecitabine — for people with HER2-negative metastatic breast cancer that has spread to the brain. It aims to find out if this treatment can shrink brain tumors. **You may be eligible if...** - You have HER2-negative metastatic breast cancer (your cancer does not overexpress the HER2 protein) - Your cancer has spread to the brain and you have at least one measurable brain lesion on MRI (1 cm or larger) - You are 18 years or older - Your overall health and daily functioning are good (ECOG score 0 or 1) - You have received no more than 3 prior chemotherapy regimens for advanced or metastatic disease - Your blood counts, liver, and kidney function are adequate **You may NOT be eligible if...** - You are pregnant, breastfeeding, or not using adequate contraception - You have already received too many prior lines of chemotherapy - Your general health is too poor to handle treatment - You have a life expectancy of less than 3 months 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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Interventions

DRUGUtidelone

Utidelone 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle.

DRUGUtidelone in combination with capecitabine

UTD1 25 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.

DRUGUtidelone in combination with capecitabine

Utidelone 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.

DRUGUtidelone in combination with capecitabine

Utidelone 25 mg/m2/d or 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.

Locations(17)

City of Hope--Duarte

Duarte, California, United States

Cancer & Blood Research Center, LLC

Los Alamitos, California, United States

Univ. of California Los Angeles

Los Angeles, California, United States

FOMAT Medical Research (Network)

Oxnard, California, United States

Scripps Health

San Diego, California, United States

University Of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, United States

Biosresearch Partner

Hialeah, Florida, United States

D&H Cancer Research Center

Margate, Florida, United States

Augusta University

Augusta, Georgia, United States

Robert H. Lurie Comprehensive Cancer Center Northwestern University

Chicago, Illinois, United States

The Johns Hopkins Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Profound Research LLC

Farmington Hills, Michigan, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Stony Brook Cancer Center

Stony Brook, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

Community Clinical Trials

Kingwood, Texas, United States

Tranquil Clinical Research

Webster, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06764940