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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02089854

Collaborator

(none)

800

Enrollment

Location

Arms

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Female Breast Cancer	Drug: Toremifene; Anastrozole	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2014

Anticipated Primary Completion Date :

Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: endocrine therapy toremifene 60mg PO. per day for premenopausal and perimenopausal patients; anastrozole 1mg PO. per day for postmenopausal patients	Drug: Toremifene; Anastrozole Toremifene 60mg PO. per day for premenopausal and perimenopausal patients; Anastrozole 1mg PO. per day for postmenopausal patients
No Intervention: observation

Arm

Intervention/Treatment

Experimental: endocrine therapy

toremifene 60mg PO. per day for premenopausal and perimenopausal patients; anastrozole 1mg PO. per day for postmenopausal patients

Drug: Toremifene; Anastrozole

Toremifene 60mg PO. per day for premenopausal and perimenopausal patients; Anastrozole 1mg PO. per day for postmenopausal patients

No Intervention: observation

Outcome Measures

Primary Outcome Measures

disease-free survival [5 years]

Secondary Outcome Measures

overall survival [5 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.