Utidelone in Combination With AC Versus Docetaxel in Combination With AC for Neoadjuvant Chemotherapy in Patients With HER2-negative Breast Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

552

Participants

Timeline

Start Date

May 30, 2023

Primary Completion Date

June 15, 2025

Study Completion Date

December 31, 2025

Conditions
Breast Cancer
Interventions
DRUG

Utidelone Injection in combination with AC

"The treatment group will be treated with Utidelone Injection at 30 mg/m2/d administered intravenously once daily on days 1-5 of each cycle, and Doxorubicin Injection at 50mg/m2 and Cyclophosphamide Injection at 500 mg/m2, administered intravenously respectively once daily on day 1 of each cycle. One treatment cycle has 21 days, and there are 6 cycles in total.~After the neoadjuvant therapy, all patients suitable for surgery will have the operation, and they will be evaluated pre-operatively for clinical remission according to RECIST 1.1. For patients unsuitable for surgery, they will receive other treatments according to the clinical practice at each site.~Safety evaluation will be performed 28 days after the last dose, and patients will be followed up for at least 3 years for disease recurrence."

DRUG

Docetaxel Injection in combination with AC

"The control group will be treated with Docetaxel Injection at 75 mg/m2, Doxorubicin Injection at 50 mg/m2, and Cyclophosphamide Injection at 500mg/m2, administered intravenously once on day 1 of each cycle. One cycle has 21 days, and there are 6 cycles in total.~After the neoadjuvant therapy, all patients suitable for surgery will have the operation, and they will be evaluated pre-operatively for clinical remission according to RECIST 1.1. For patients unsuitable for surgery, they will receive other treatments according to the clinical practice at each site.~Safety evaluation will be performed 28 days after the last dose, and patients will be followed up for at least 3 years for disease recurrence."

Trial Locations (1)

Unknown

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

Beijing Biostar Pharmaceuticals Co., Ltd.

INDUSTRY