Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT02062489
PHASE3

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

Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

688

Start Date

2014-05

Completion Date

2026-05

Last Updated

2022-04-27

Healthy Volunteers

No

Conditions

Interventions

DRUG

Tamoxifen

20 mg(2#)/day, PO, daily

DRUG

Placebo

2#/day, PO, daily

Locations (17)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Guangdong Women and Children Hospital

Guangzhou, Guangdong, China

Guangzhou Army General Hospital

Guangzhou, Guangdong, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Guangzhou Women and Children Hospital

Guangzhou, Guangdong, China

The third people's Hospital of Huizhou

Huizhou, Guangdong, China

Xinjiang Medical School Cancer Center

Xinjiang, Xinjiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Dongguan People's Hospital

Dongguan, China

Foshan First People's Hospital

Foshan, China

The sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Zhejiang Provincial People's Hospital

Hangzhou, China

Lian Jiang People's Hospital

Lianjiang, China

The Third Hospital of Nanchang

Nanchang, China

The Second People's Hospital of Shenzhen

Shenzhen, China