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

  • STATUS
    Recruiting
  • End date
    May 18, 2026
  • participants needed
    688
  • sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Updated on 18 May 2022
endocrine therapy
metastasis
hormone therapy
HER2
adjuvant therapy
tamoxifen
erbb2
herceptin
mastectomy
axillary lymph node dissection
immunostimulant
sentinel node
breast-conserving surgery
mammogram
sentinel lymph node biopsy

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.

Details
Condition Breast Cancer
Treatment Placebo, tamoxifen
Clinical Study IdentifierNCT02062489
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Last Modified on18 May 2022

Eligibility

Yes No Not Sure

Inclusion 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
The patients have normal cardiac functions by echocardiography
The patients' ECOG scores are ≤0-2
Female patient who is ≥ 18yrs, and ≤ 70yrs
The patients are non-pregnant, and disposed to practice contraception during the whole trial
The patients underwent neoadjuvant chemotherapy plus surgery or directly modified radical mastectomy or breast-conserving surgery (plus sentinel lymph node biopsy or axillary lymph node dissection) after diagnosis of breast cancer
The patients underwent chemotherapy, radiation therapy or targeted therapy(herceptin) after surgery according to the 2013 NCCN guideline
The results of patients' blood tests are as follows
Hb≥90g/L; WBC≥4.0×109/L; Plt≥100×109/L; Neutrophils≥1.5×109/L; ALT and AST ≤ triple of
normal upper limit; TBIL ≤ 1.5 times of normal upper limit; Creatinine ≤ 1.25 times of
normal upper limit

Exclusion Criteria

The patients have other cancers at the same time or have the history of other cancers
except controlled skin basal cell carcinoma or skin squamous cell carcinoma or
The patients have active infections that were not suitable for chemotherapy
The patients have severe non-cancerous diseases
carcinoma in situ of cervix uterus
The patients have history of neoadjuvant hormone therapy
The patients have bilateral breast cancers or DCIS or metastatic breast cancers
The patients are undergoing current administration of anti-cancer therapies, or are
The patients have allergic history or contraindication of tamoxifen
attending other clinical trials
The patients are pregnant or lactational, or they refuse to practice contraception
during the whole trial
The patients are in some special conditions that they can't understand the written
informed consent, such as they are demented or hawkish
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