The current study is a multicentre, randomized,double-blind, prospective clinical trial stratified patients by the HER2 status of their cancer (negative or positive) which is sponsored by the researchers. The trial is designed to evaluate the effectiveness of tamoxifen as adjuvant therapy for ER(ER-α)/PR negative, ER-β positive operable breast cancer patients. 688 female ER(ER-α)/PR negative, ER-β(wild type ER-β1) positive operable breast cancer patients who had undergone neoadjuvant chemotherapy or directly modified radical mastectomy or breast-conserving surgery were randomly (1:1) enrolled to receive tamoxifen (20 mg per day) or placebo (2# per day) within 6 weeks after postoperative chemotherapy and/or radiation therapy if needed (according to 2013 NCCN breast cancer guideline). If the breast tumor's HER2 is positive, the patient can receive targeted therapy (Herceptin) combined with tamoxifen or placebo. The follow-up time will be eight years. The aim of this trial is to evaluate the effectiveness of tamoxifen as adjuvant therapy for ER(ER-α)/PR negative, ER-β positive operable breast cancer patients by comparing the DFS and OS between tamoxifen group and placebo group and to determine whether the percentage of positive ER-β expression is associated with the response to the hormone therapy in breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
688
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Sun Yat-sen University
Guangzhou, 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
RECRUITINGSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGGuangzhou Women and Children Hospital
Guangzhou, Guangdong, China
RECRUITINGThe third people's Hospital of Huizhou
Huizhou, Guangdong, China
RECRUITINGXinjiang Medical School Cancer Center
Xinjiang, Xinjiang, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITING...and 7 more locations
Disease-free survival of patients
Time frame: within 10 years after diagnosis
Rates of adverse reactions
Time frame: within 5 years when patients is undergoing tamoxifen or placebo treatment
Distant metastasis-free survival
Time frame: within 10 years after diagnosis
Overall survival
Time frame: within 10 years after diagnosis
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