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Recruiting Phase 3 NCT02535221

Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer

Trial Parameters

Condition Breast Cancer
Sponsor Peking University
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 234
Sex FEMALE
Min Age 35 Years
Max Age 55 Years
Start Date 2015-07-29
Completion 2026-06-30
Interventions
Goserelin+TAM+AIEpirubicin+CTX+5-Fu

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 35 years old \<age≤55 years old, in premenopausal status(with the judgement by researchers when the patients are recruited) Histologically confirmed primary invasive breast cancer * 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: * Metastasis disease by pathological or radiological diagnosis * the history of other tumor * contradiction for the third generation AIs, LHRHa, chemotherapy * Contradiction for adjuvant chemotherapy: serious cardiology or cerebral vessel disease, live

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