Evaluation of Tamoxifen's Efficacy for ER/PR Negative,ER-beta Positive Operable Breast Cancer Patients
NCT ID: NCT02062489
Last Updated: 2022-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
688 participants
INTERVENTIONAL
2014-05-31
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tamoxifen
20mg(2#)/day, PO, daily, five years
Tamoxifen
20 mg(2#)/day, PO, daily
Placebo
2#/day, PO, daily, five years
Placebo
2#/day, PO, daily
Interventions
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Tamoxifen
20 mg(2#)/day, PO, daily
Placebo
2#/day, PO, daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
FEMALE
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Erwei Song, M.D., Ph.D.
Vice President of Sun Yat-Sen Memorial Hospital
Principal Investigators
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Erwei Song, M.D.,Ph.D.
Role: STUDY_CHAIR
Sun Yat-Sen Memerial Hospital of Sun Yat-Sen University
Qiang Liu, MD.PhD.
Role: STUDY_DIRECTOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Wenbo Zheng
Role: primary
Zhuanghong Wu, M.D.
Role: primary
Anqin Zhang
Role: primary
Chenfang Zhang
Role: primary
Hongmin Ma
Role: primary
Yanpeng Zou, M.D.
Role: primary
Binlin Ma, M.D.
Role: primary
Gang Sun, M.D.
Role: backup
Hongjian Yang, M.D.
Role: primary
Xuezhong Gao
Role: primary
Guolin Ye
Role: primary
Haiyan Li, MD
Role: primary
Xuli Meng
Role: primary
Heng Huang
Role: primary
Zhihua Li
Role: primary
Xianming Wang
Role: primary
Other Identifiers
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BCCT2014001
Identifier Type: -
Identifier Source: org_study_id
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