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Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer
Sponsor: Peking University
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.
Official title: Randomized Trial of Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With Estrogen Receptor-Positive HER2 Negative Breast Cancer
Key Details
Gender
FEMALE
Age Range
35 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
234
Start Date
2015-07-29
Completion Date
2026-12-31
Last Updated
2021-11-29
Healthy Volunteers
No
Conditions
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.
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.
Locations (1)
Beijing Cancer Hospital Breast Center
Beijing, China