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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifen | Active Comparator | 20mg(2#)/day, PO, daily, five years |
|
| Placebo | Placebo Comparator | 2#/day, PO, daily, five years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen | Drug | 20 mg(2#)/day, PO, daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival of patients | within 10 years after diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of adverse reactions | within 5 years when patients is undergoing tamoxifen or placebo treatment | |
| Distant metastasis-free survival | within 10 years after diagnosis | |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| Placebo | Drug | 2#/day, PO, daily |
|
| Overall survival |
| within 10 years after diagnosis |
| The First Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
|
| Guangdong Women and Children Hospital | Recruiting | Guangzhou | Guangdong | 510010 | China |
|
| Guangzhou Army General Hospital | Recruiting | Guangzhou | Guangdong | 510010 | China |
|
| Sun Yat-Sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
|
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510120 | China |
|
| Guangzhou Women and Children Hospital | Recruiting | Guangzhou | Guangdong | 510180 | China |
|
| The third people's Hospital of Huizhou | Recruiting | Huizhou | Guangdong | 516000 | China |
|
| Xinjiang Medical School Cancer Center | Recruiting | Xinjiang | Xinjiang | China |
|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
|
| Dongguan People's Hospital | Recruiting | Dongguan | China |
|
| Foshan First People's Hospital | Recruiting | Foshan | China |
|
| The sixth Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | China |
|
| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | China |
|
| Lian Jiang People's Hospital | Recruiting | Lianjiang | China |
|
| The Third Hospital of Nanchang | Recruiting | Nanchang | China |
|
| The Second People's Hospital of Shenzhen | Recruiting | Shenzhen | China |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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