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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tamoxifen
Placebo
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer,, tamoxifen,, ER/PR negative, ER-beta positive

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • The First Affiliated Hospital of Sun Yat-sen UniversityRecruiting
  • Guangdong Women and Children HospitalRecruiting
  • Guangzhou Army General HospitalRecruiting
  • Sun Yat-Sen University Cancer CenterRecruiting
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruiting
  • Guangzhou Women and Children HospitalRecruiting
  • The third people's Hospital of HuizhouRecruiting
  • Xinjiang Medical School Cancer CenterRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • Dongguan People's HospitalRecruiting
  • Foshan First People's HospitalRecruiting
  • The sixth Affiliated Hospital of Sun Yat-sen UniversityRecruiting
  • Zhejiang Provincial People's HospitalRecruiting
  • Lian Jiang People's HospitalRecruiting
  • The Third Hospital of NanchangRecruiting
  • The Second People's Hospital of ShenzhenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tamoxifen

Placebo

Arm Description

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

2#/day, PO, daily, five years

Outcomes

Primary Outcome Measures

Disease-free survival of patients

Secondary Outcome Measures

Rates of adverse reactions
Distant metastasis-free survival
Overall survival

Full Information

First Posted
February 12, 2014
Last Updated
April 19, 2022
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02062489
Brief Title
Evaluation of Tamoxifen's Efficacy for ER/PR Negative,ER-beta Positive Operable Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 2014 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer,, tamoxifen,, ER/PR negative, ER-beta positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
688 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tamoxifen
Arm Type
Active Comparator
Arm Description
20mg(2#)/day, PO, daily, five years
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2#/day, PO, daily, five years
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Other Intervention Name(s)
Nolvadex
Intervention Description
20 mg(2#)/day, PO, daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2#/day, PO, daily
Primary Outcome Measure Information:
Title
Disease-free survival of patients
Time Frame
within 10 years after diagnosis
Secondary Outcome Measure Information:
Title
Rates of adverse reactions
Time Frame
within 5 years when patients is undergoing tamoxifen or placebo treatment
Title
Distant metastasis-free survival
Time Frame
within 10 years after diagnosis
Title
Overall survival
Time Frame
within 10 years after diagnosis

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erwei Song, M.D., Ph. D.
Phone
86-20-81332576
Email
songerwei02@yahoo.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Liu, M.D., Ph. D.
Phone
86-20-81332576
Email
victorlq@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erwei Song, M.D.,Ph.D.
Organizational Affiliation
Sun Yat-Sen Memerial Hospital of Sun Yat-Sen University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Qiang Liu, MD.PhD.
Organizational Affiliation
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenbo Zheng
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuanghong Wu, M.D.
Facility Name
Guangdong Women and Children Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anqin Zhang
Phone
86-13925115929
Facility Name
Guangzhou Army General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenfang Zhang
Phone
86-13889908978
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoming Xie, M.D.,Ph.D.
Phone
86-13826109540
Email
xiexm@sysucc.org.cn
Facility Name
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erwei Song, M.D.,Ph.D.
Email
songerwei02@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Qiang Liu
Email
victorlq@hotmail.com.com
First Name & Middle Initial & Last Name & Degree
Erwei Song, M.D.,Ph.D.
Facility Name
Guangzhou Women and Children Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongmin Ma
Phone
86-13922723808
Facility Name
The third people's Hospital of Huizhou
City
Huizhou
State/Province
Guangdong
ZIP/Postal Code
516000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanpeng Zou, M.D.
Facility Name
Xinjiang Medical School Cancer Center
City
Xinjiang
State/Province
Xinjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binlin Ma, M.D.
First Name & Middle Initial & Last Name & Degree
Gang Sun, M.D.
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongjian Yang, M.D.
Facility Name
Dongguan People's Hospital
City
Dongguan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuezhong Gao
Facility Name
Foshan First People's Hospital
City
Foshan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guolin Ye
Facility Name
The sixth Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyan Li, MD
Phone
8615813340604
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuli Meng
Facility Name
Lian Jiang People's Hospital
City
Lianjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heng Huang
Facility Name
The Third Hospital of Nanchang
City
Nanchang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihua Li
Facility Name
The Second People's Hospital of Shenzhen
City
Shenzhen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianming Wang

12. IPD Sharing Statement

Learn more about this trial

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

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