Adjuvant Endocrine Therapy for Estrogen Receptor-beta Positive Triple Negative Breast Cancer

Study Overview
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Brief Summary
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The study is a prospective multi-center randomized control clinical trial which is sponsored by the researchers. The purpose of this study is to determine the effectiveness of adjuvant endocrine therapy for operable ER-beta positive, ER-alpha/PR negative, Her-2 negative breast cancer(triple negative breast cancer, TNBC) patients. The ER-beta positive TNBC patients who had undergone modified radical mastectomy or breast-conserving surgery were randomly (1:1) enrolled to receive toremifene (60 mg per day for premenopausal and perimenopausal patients) /anastrozole(1mg per day for postmenopausal patients) or observation within 4 weeks after adjuvant chemotherapy and/or radiation therapy if necessary.The follow-up time will be at least five years. The disease free survival(DFS) and overall survival(OS) between endocrine group and observation group will be compared to evaluate the effectiveness.

Official Title
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Evaluation of Adjuvant Endocrine Therapy for Operable ER-beta Positive, ER-alpha/PR Negative, Her-2 Negative Breast Cancer Patients

Conditions
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Female Breast Cancer

Intervention / Treatment
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* Drug: Toremifene; Anastrozole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients signed the written informed consent. The patients present with histologically proven operable invasive breast cancers without distant metastasis. The breast tumor's positive ER/PR rate is <1%, and positive ER-beta rate is ≥1% by immuno-histochemistry(IHC). The patients have no history of neoadjuvant hormone therapy. The patients' Karnofsky performance score ≥70%. Female patient who is ≥ 18yrs, and ≤ 80yrs. 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 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; Neutrophils≥1.5×109/L; Plt≥100×109/L; alanine aminotransferase(ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN); total bilirubin(TBIL) ≤ 1.5×ULN; Creatinine ≤ 1.25×ULN. Exclusion Criteria: The patients have a previous history of invasive malignant disease (breast cancer at any time, other malignant disorders within the past 10 years excluding squamous or basal-cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied). The patients have any severe concomitant disease which will place the patient at unusual risk or confound the results of the trial. The patients have history of neoadjuvant hormone therapy. The patients are undergoing current administration of anti-cancer therapies, or are attending other clinical trials. The patients are pregnant or lactational, or they refuse to practice contraception during the whole trial. The patients are unwilling to stop any hormonal drug including hormone replacement therapy(HRT). The patients can't understand the written informed consent; such as they have dementia. The patients have allergic history or contraindication of toremifene/anastrozole.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endocrine therapy<br>toremifene 60mg PO. per day for premenopausal and perimenopausal patients; anastrozole 1mg PO. per day for postmenopausal patients | Drug: Toremifene; Anastrozole<br>* Toremifene 60mg PO. per day for premenopausal and perimenopausal patients; Anastrozole 1mg PO. per day for postmenopausal patients<br>|
| No Intervention: observation<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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triple negative breast cancer, estrogen receptor-beta, endocrine therapy