The purpose of this clinical trial is to evaluate the efficacy and safety of Utidelone plus AC versus Docetaxel plus AC as neoadjuvant chemotherapy in high-risk HER2-negative early-stage or locally advanced breast cancer. In this phase III, multi-center, open-label, randomized controlled study, 552 subjects will be enrolled and randomly assigned in a 1:1 ratio to either the Utidelone plus AC group or the docetaxel plus AC group, stratified by hormone receptor status (ER and/or PgR positive vs ER and PgR negative).
The subjects in treatment group will be treated with Utidelone at 30 mg/m2/d administered intravenously once daily on days 1-5 of each cycle, and doxorubicin at 50mg/m2 and cyclophosphamide at 500 mg/m2, administered intravenously once daily on day 1 of each cycle. One treatment cycle has 21 days, and there are in total 6 cycles. The subjects in control group will be treated with docetaxel at 75 mg/m2, doxorubicin at 50 mg/m2, and cyclophosphamide 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 should take the operation, and patients will be evaluated pre-operatively for clinical remission according to RECIST 1.1. After the surgery, patients will be evaluated for pathological remission, and physicians will recommend, according to clinical practice guidelines and clinical practice at each site, radiotherapy or adjuvant therapy for patients with corresponding clinical indications, and endocrine therapy for ER positive and/or PgR positive patients. Patients unsuitable for surgery 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
552
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.
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.
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGTotal Pathologic Complete Response
tpCR (ypT0/is, ypN0), percentage of patients with absence of invasive neoplastic cells in ipsilateral lymph nodes and the breast
Time frame: 24 months
Breast Pathologic Complete Response
ypT0/is, percentage of patients whose pathological evaluation of hematoxylin and eosin-stained breast samples do not show any residual invasive carcinoma.
Time frame: 24 months
Objective Response Rate
Proportion of subjects who get to CR or PR during neoadjuvant therapy
Time frame: 24 months
3-year Event Free Survival
Event of interest, which included preoperative disease progression, postoperative disease recurrence, and death from any cause.
Time frame: 36 months
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