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Evaluation of Tamoxifen's Efficacy for ER/PR Negative,ER-beta Positive Operable Breast Cancer Patients
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Summary
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.
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
688
Start Date
2014-05
Completion Date
2026-05
Last Updated
2022-04-27
Healthy Volunteers
No
Conditions
Interventions
Tamoxifen
20 mg(2#)/day, PO, daily
Placebo
2#/day, PO, daily
Locations (17)
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Guangdong Women and Children Hospital
Guangzhou, Guangdong, China
Guangzhou Army General Hospital
Guangzhou, Guangdong, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Guangzhou Women and Children Hospital
Guangzhou, Guangdong, China
The third people's Hospital of Huizhou
Huizhou, Guangdong, China
Xinjiang Medical School Cancer Center
Xinjiang, Xinjiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Dongguan People's Hospital
Dongguan, China
Foshan First People's Hospital
Foshan, China
The sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
Zhejiang Provincial People's Hospital
Hangzhou, China
Lian Jiang People's Hospital
Lianjiang, China
The Third Hospital of Nanchang
Nanchang, China
The Second People's Hospital of Shenzhen
Shenzhen, China