The purpose of this study is to compare the pathological complete response (pCR) rate in triple-negative or Her2 positive breast cancer patients treated with neoadjuvant docetaxel, anthracycline and cyclophosphamide (TAC) or docetaxel and cyclophosphamide (TC) regimen.
Breast cancer is the leading cause of cancer in women in China. Neoadjuvant chemotherapy for treatment of locally advanced breast cancer has become a standard therapy. Results from neoadjuvant trials have shown that pathological complete response (pCR) is an independent predictor of outcome. Docetaxel was introduced into clinical practice in the early 1990s and has demonstrated good activity in the adjuvant and metastatic settings. Both TC and TAC are effective regimens in the adjuvant setting. The most optimal regimen in the neoadjuvant treatment is however unknown. This is especially true in triple-negative or HER2 positive breast cancer. This study will evaluate the pCR rate of TAC and TC as neoadjuvant treatment for triple-negative or HER2 positive breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Docetaxel 75mg/m2, doxorubicin 50mg/m2 or epirubicin 60mg/m2, cyclophosphamide 500mg/m2 every 3 weeks for six cycles
Docetaxel 75mg/m2, cyclophosphamide 600mg/m2 every 3 weeks for six cycles
pathological complete remission (pCR) rate
Time frame: after 6 cycles of neoadjuvant therapy
disease free survival (DFS) and overall survival (OS)
Time frame: 5-year
clinical response rate
Time frame: after 6 cycles of neoadjuvant therapy
safety profile
Time frame: during neoadjuvant therapy
breast conservation therapy (BCT) rate
Time frame: after surgery
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The First People's Hospital of Foshan
Foshan, Guangdong, China
Guangdong Provincial Maternal and Child Health Hospital
Guangzhou, Guangdong, China
Guangzhou General Hospital of Guangzhou Military Area
Guangzhou, Guangdong, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangyin People's Hospital
Jiangyin, Jiangsu, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
The Second Affilliated Hospital of Suzhou University
Suzhou, Jiangsu, China
Wujiang First People's Hospital
Wujiang, Jiangsu, China
The third hospital of Nanchang
Nanchang, Jiangxi, China
...and 17 more locations