The current study is a multicentre, randomized, open (unblended), prospective clinical trial which is sponsored by the researchers. The trial is designed to compare the effectiveness between docetaxel plus epirubicin, and docetaxel plus epirubicin plus cyclophosphamide as neoadjuvant chemotherapy for operable premenopausal breast cancer patients, and also to compare the outcomes associated with chemo-induced amenorrhea between the two neoadjuvant chemotherapies. The investigators will randomly assign 600 premenopausal female patients with operable breast cancer to receive four cycles of docetaxel and epirubicin (TE); or four cycles of docetaxel, epirubicin, and cyclophosphamide (TEC). After every two cycles of neoadjuvant chemotherapy, the investigators will estimate the effectiveness of therapy. Patients will undergo modified radical mastectomy or breast-conserving surgery after four cycles of neoadjuvant chemotherapy, and then receive postoperative chemotherapy (two cycles), radiation therapy, herceptin targeted therapy or hormone therapy according to the NCCN (2011) guideline. The follow-up will be ten years after surgeries. The primary aim is to examine whether the docetaxel and epirubicin (TE) will be as effective as the docetaxel, epirubicin, and cyclophosphamide (TEC) (pCR rate, cCR rate, PR rate, SD rate, progression-free survival (PFS) and overall survival (OS)). The secondary aim is to correlate chemo (TE/TEC)-induced amenorrhea with outcomes in premenopausal women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
75mg/m2, iv injection, day1, every 21 days
80mg/ m2, iv injection, day1, every 21 days
500 mg/m2, iv injection, day1, every 21 days
Two weeks after four cycles of neoadjuvant chemotherapy
Two weeks after surgery,75mg/m2, iv injection, day1, every 21 days, 4 cycles totally.
Two weeks after surgery, 80mg/m2,iv injection, day1, every 21 days, 4 cycles totally
Two weeks after surgery, 500mg/m2, iv injection, day1, every 21 days, 4 cycles totally.
Two weeks after post-operative chemotherapy, perform radiation therapy based on 2011 NCCN guideline.
Perform herceptin therapy (one year) based on 2011 NCCN guideline if the pathological test of the operative tumor sample showed HER2 positive.
After radiation therapy, totally five years. Perform hormone therapy based on 2011 NCCN guideline if the tumor is ER/PR positive.
The first People's Hospital of Foshan
Foshan, Guangdong, China
RECRUITINGGuangdong Women and Children Hospital
Guangzhou, Guangdong, China
RECRUITINGGuangzhou Army General Hospital
Guangzhou, Guangdong, China
RECRUITINGSun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGTumor Hospital of Guangzhou
Guangzhou, Guangdong, China
RECRUITINGThe Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China
RECRUITINGSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGGuangzhou Women and Children Hospital
Guangzhou, Guangdong, China
RECRUITINGThe first People's Hospital of Guangzhou
Guangzhou, Guangdong, China
RECRUITING...and 7 more locations
Progression-free survival of patients.
Time frame: within 10 years after diagnosis
Overall survival of the patients
Time frame: within 10 years after diagnosis
The pathological remission rate of patients after neoadjuvant chemotherapy.
Time frame: within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)
The clinical remission rate of patients after neoadjuvant chemotherapy
Time frame: within 80 days after diagnosis (after 4 cycles of neoadjuvant chemotherapy)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.