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

NCT02062489 | Recruiting Phase 3 DMC

• 1 other identifier: BCCT2014001
• Study Type: interventional
• Target: 688
• Locations: 1 country
• Sites: 17

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.

Conditions

Breast Cancer

Keywords

breast cancer,; tamoxifen,; ER/PR negative, ER-beta positive

Outcome Measures

Primary Outcomes (1)

• Disease-free survival of patients

  within 10 years after diagnosis

Secondary Outcomes (3)

• Rates of adverse reactions

  within 5 years when patients is undergoing tamoxifen or placebo treatment

• Distant metastasis-free survival

  within 10 years after diagnosis

• Overall survival

  within 10 years after diagnosis

Study Arms (2)

Tamoxifen

ACTIVE COMPARATOR

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

Drug: Tamoxifen

Placebo

PLACEBO COMPARATOR

2#/day, PO, daily, five years

Drug: Placebo

Interventions

Tamoxifen DRUG

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

Also known as: Nolvadex

Tamoxifen

Placebo DRUG

2#/day, PO, daily

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (17)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Guangdong Women and Children Hospital

Guangzhou, Guangdong, 510010, China

RECRUITING

Guangzhou Army General Hospital

Guangzhou, Guangdong, 510010, China

RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

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

Guangzhou, Guangdong, 510120, China

RECRUITING

Guangzhou Women and Children Hospital

Guangzhou, Guangdong, 510180, China

RECRUITING

The third people's Hospital of Huizhou

Huizhou, Guangdong, 516000, China

RECRUITING

Xinjiang Medical School Cancer Center

Xinjiang, Xinjiang, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Dongguan People's Hospital

Dongguan, China

RECRUITING

Foshan First People's Hospital

Foshan, China

RECRUITING

The sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, China

RECRUITING

Lian Jiang People's Hospital

Lianjiang, China

RECRUITING

The Third Hospital of Nanchang

Nanchang, China

RECRUITING

The Second People's Hospital of Shenzhen

Shenzhen, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Erwei Song, M.D.,Ph.D.

  Sun Yat-Sen Memerial Hospital of Sun Yat-Sen University

  STUDY CHAIR

• Qiang Liu, MD.PhD.

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

  STUDY DIRECTOR

Central Study Contacts

Erwei Song, M.D., Ph. D.

CONTACT

86-20-81332576; songerwei02@yahoo.com.cn

Qiang Liu, M.D., Ph. D.

CONTACT

86-20-81332576; victorlq@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Sun Yat-Sen Memorial Hospital

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 13, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

CN (17)