adjuvant endocrine therapy for estrogen receptor-beta positive triple negative breast cancer

Conditions: Female Breast Cancer

Summary: 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.


Eligibility criteria:
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.

Keywords: triple negative breast cancer estrogen receptor-beta endocrine therapy