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RECRUITING
NCT02535221
PHASE3

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

Sponsor: Peking University

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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