Evaluation of Tamoxifen's Efficacy for ER/PR Negative,ER-beta Positive Operable Breast Cancer Patients
Status:
Recruiting
Trial end date:
2024-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University