Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer
NCT ID: NCT02535221
Last Updated: 2021-11-29
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
234 participants
INTERVENTIONAL
2015-07-29
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Endocrine therapy;
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.
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
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stage: T2N0M0(cT\>2cm, SLNB negative), hard to proceed the breast conserving surgery(not feasible or may affect the appearance of breast)
* Histologically confirmed HR+ (ER or PR positive, and \>50% cell in IHC) HER2 negative breast cancer by pathological evaluation
* No other previous treatment for primary breast cancer
* Without other tumor or unstable complication or uncontrolled infection
* No contradiction for the third generation AIs, LHRHa, chemotherapy
* Attend the study voluntarily, sign the informed consent.
Exclusion Criteria
* the history of other tumor
* contradiction for the third generation AIs, LHRHa, chemotherapy
* Contradiction for adjuvant chemotherapy: serious cardiology or cerebral vessel disease, liver or kidney disfunction, blood system disease, the other situation or complication that are not suitable or cannot adaptable for chemotherapy
* Contradiction for proceeding surgery: contradiction for anesthesia, large lesion,T4, lymph node positive
* other situation not suitable for the research: psychological disease, mental disorder, social problem, geographic problem
* have been attendance in other anti-tumor treatment or other clinical trials 8) reject to attend the study
35 Years
55 Years
FEMALE
No
Sponsors
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Peking University
OTHER
Responsible Party
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Tao OUYANG
Chairman of Breast Center of Peking University Cancer Hospital
Principal Investigators
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Tao Ouyang, MD
Role: STUDY_CHAIR
Peking University Cancer Hospital & Institute
Locations
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Beijing Cancer Hospital Breast Center
Beijing, , China
Countries
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Central Contacts
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References
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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.
Other Identifiers
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BCP12
Identifier Type: -
Identifier Source: org_study_id