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

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

July 14, 2025

Primary Completion Date

January 15, 2027

Study Completion Date

July 15, 2027

Conditions
HER2-negative Breast Cancer Patients With Brain Metastases
Interventions
DRUG

Utidelone

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

DRUG

Utidelone 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.

DRUG

Utidelone 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.

DRUG

Utidelone 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.

Trial Locations (16)

22751

RECRUITING

Community Clinical Trials, Kingwood

27858

NOT_YET_RECRUITING

East Carolina University, Greenville

30912

NOT_YET_RECRUITING

Augusta University, Augusta

33013

RECRUITING

Biosresearch Partner, Hialeah

33063

RECRUITING

D&H Cancer Research Center, Margate

48334

RECRUITING

Profound Research LLC, Farmington Hills

60611

NOT_YET_RECRUITING

Robert H. Lurie Comprehensive Cancer Center Northwestern University, Chicago

77030

NOT_YET_RECRUITING

MD Anderson Cancer Center, Houston

77598

RECRUITING

Tranquil Clinical Research, Webster

80045

RECRUITING

University Of Colorado Hospital - Anschutz Cancer Pavilion, Aurora

89169

RECRUITING

Comprehensive Cancer Centers of Nevada, Las Vegas

90720

RECRUITING

Cancer & Blood Research Center, LLC, Los Alamitos

91010

NOT_YET_RECRUITING

City of Hope--Duarte, Duarte

92121

RECRUITING

Scripps Health, San Diego

93030

RECRUITING

FOMAT Medical Research (Network), Oxnard

11794-7263

NOT_YET_RECRUITING

Stony Brook Cancer Center, Stony Brook

Sponsors
All Listed Sponsors
lead

Biostar Pharma, Inc.

INDUSTRY

NCT06764940 - A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases | Biotech Hunter | Biotech Hunter