Evaluation of Tamoxifen's Efficacy for ER/PR Negative,ER-beta Positive Operable Breast Cancer Patients

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

Trial Details

NCT ID
NCT02062489
Phase
PHASE3
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Tamoxifen
  • Placebo
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • The patients signed the written informed consent
  • The patients present with operable unilateral invasive breast cancers without distant metastasis(stage I, II, and III)
  • The breast tumor's positive ER/PR rate is \<1%, and positive ER-beta1 rate is ≥10% by IHC.
  • The patients have no history of neoadjuvant hormone therapy.

For full eligibility, visit ClinicalTrials.gov.

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