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

April 19, 2022 updated by: Erwei Song, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

688

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Dongguan, China
        • Recruiting
        • Dongguan people's hospital
        • Contact:
          • Xuezhong Gao
      • Foshan, China
        • Recruiting
        • Foshan First People's Hospital
      • Guangzhou, China
        • Recruiting
        • The Sixth Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Haiyan Li, MD
          • Phone Number: 8615813340604
      • Hangzhou, China
        • Recruiting
        • Zhejiang Provincial People's Hospital
      • Lianjiang, China
        • Recruiting
        • Lian Jiang People'S Hospital
        • Contact:
          • Heng Huang
      • Nanchang, China
        • Recruiting
        • The Third Hospital of Nanchang
      • Shenzhen, China
        • Recruiting
        • The second people's Hospital of Shenzhen
        • Contact:
          • Xianming Wang
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Wenbo Zheng
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Zhuanghong Wu, M.D.
      • Guangzhou, Guangdong, China, 510010
        • Recruiting
        • Guangdong Women and Children Hospital
        • Contact:
          • Anqin Zhang
          • Phone Number: 86-13925115929
      • Guangzhou, Guangdong, China, 510010
        • Recruiting
        • Guangzhou Army General Hospital
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
      • Guangzhou, Guangdong, China, 510180
        • Recruiting
        • Guangzhou Women and Children Hospital
      • Huizhou, Guangdong, China, 516000
        • Recruiting
        • The Third People's Hospital of Huizhou
        • Contact:
          • Yanpeng Zou, M.D.
    • Xinjiang
      • Xinjiang, Xinjiang, China
        • Recruiting
        • Xinjiang Medical School Cancer Center
        • Contact:
          • Binlin Ma, M.D.
        • Contact:
          • Gang Sun, M.D.
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Hongjian Yang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • The patients signed the written informed consent
  • The patients present with operable unilateral invasive breast cancers without distant metastasis(stage I, II, and III)
  • The breast tumor's positive ER/PR rate is <1%, and positive ER-beta1 rate is ≥10% by IHC.
  • The patients have no history of neoadjuvant hormone therapy.
  • The patients have normal cardiac functions by echocardiography.
  • The patients' ECOG scores are ≤0-2.
  • Female patient who is ≥ 18yrs, and ≤ 70yrs.
  • 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 or targeted therapy(herceptin) 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; Plt≥100×109/L; Neutrophils≥1.5×109/L; ALT and AST ≤ triple of normal upper limit; TBIL ≤ 1.5 times of normal upper limit; Creatinine ≤ 1.25 times of normal upper limit.

Exclusion Criteria:

  • The patients have other cancers at the same time or have the history of other cancers except controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix uterus;
  • The patients have active infections that were not suitable for chemotherapy;
  • The patients have severe non-cancerous diseases.
  • The patients have history of neoadjuvant hormone therapy.
  • The patients have bilateral breast cancers or DCIS or metastatic breast cancers.
  • 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 in some special conditions that they can't understand the written informed consent, such as they are demented or hawkish.
  • The patients have allergic history or contraindication of tamoxifen.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Tamoxifen
20mg(2#)/day, PO, daily, five years
Drug: Tamoxifen
20 mg(2#)/day, PO, daily
Other Names:
  • Nolvadex
PLACEBO_COMPARATOR: Placebo
2#/day, PO, daily, five years
Drug: Placebo
2#/day, PO, daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival of patients
Time Frame: within 10 years after diagnosis
within 10 years after diagnosis

Secondary Outcome Measures

Outcome Measure
Time Frame
Rates of adverse reactions
Time Frame: within 5 years when patients is undergoing tamoxifen or placebo treatment
within 5 years when patients is undergoing tamoxifen or placebo treatment
Distant metastasis-free survival
Time Frame: within 10 years after diagnosis
within 10 years after diagnosis
Overall survival
Time Frame: within 10 years after diagnosis
within 10 years after diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Chair: Erwei Song, M.D.,Ph.D., Sun Yat-Sen Memerial Hospital of Sun Yat-Sen University
  • Study Director: Qiang Liu, MD.PhD., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2014

Primary Completion (ANTICIPATED)

May 1, 2025

Study Completion (ANTICIPATED)

May 1, 2026

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (ESTIMATE)

February 13, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCCT2014001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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