552
Participants
Start Date
May 30, 2023
Primary Completion Date
June 15, 2025
Study Completion Date
December 31, 2025
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."
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."
RECRUITING
Fudan University Shanghai Cancer Center, Shanghai
Lead Sponsor
Beijing Biostar Pharmaceuticals Co., Ltd.
INDUSTRY