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