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This study proposes to prove that the efficacy of adjuvant endocrine therapy for the premenopausal HR positive breast cancer patients is non-inferiority to adjuvant chemotherapy assessed by ultrasound response rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endocrine therapy; | Experimental | Interventions:Goserelin+TAM+AI:Goserelin 3.6mg subcutaneous injection per 4 weeks, for 16-20weeks. TAM 10mg oral twice a day for the first four weeks(to wait the Goserelin start to work in body) than change to AI 1mg oral once a day with Goserelin for the next 12-16 weeks. |
|
| Chemotherapy | Active Comparator | Interventions:Epirubicin+CTX+5-Fu:Epirubicin(80-100 mg/m2 Q21 days) + CTX(600 mg/m2 Q 21days) + 5-Fu (600 mg/m2 Q21 days or 200 mg/m2 •day from Day1 to day 21) for four to six cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goserelin+TAM+AI | Drug | Goserelin 3.6mg subcutaneous injection per 4 weeks, for 16-20weeks. TAM 10mg oral twice a day for the first four weeks(to wait the Goserelin start to work in body) than change to AI 1mg oral once a day with Goserelin for the next 12-16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| ultrasound response rate | within 2 weeks before surgery |
| Measure | Description | Time Frame |
|---|---|---|
| pathological response rate(Miller & Payne standard) | with 2 weeks after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Ouyang, MD | Contact | ouyanghongtao@263.net |
| Name | Affiliation | Role |
|---|---|---|
| Tao Ouyang, MD | Peking University Cancer Hospital & Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital Breast Center | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40331570 | Derived | Gu C, He Y, Zhang N, Liu Y, Li J, Wang T, Fan T, Fan Z, Ouyang T. A Non-Inferior Randomized Trial of Neoadjuvant Endocrine Therapy Compared to Neoadjuvant Chemotherapy in Premenopausal Patients With Hormone-Responsive and HER2-Negative Lymph Node-Negative Breast Cancer. Cancer Control. 2025 Jan-Dec;32:10732748251339958. doi: 10.1177/10732748251339958. Epub 2025 May 7. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Epirubicin+CTX+5-Fu | Drug | Epirubicin(80-100 mg/m2 Q21 days) + CTX(600 mg/m2 Q 21days) + 5-Fu (600 mg/m2 Q21 days or 200 mg/m2 •day from Day1 to day 21) for four to six cycles. |
|
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| D017437 |
| Skin and Connective Tissue Diseases |