NCT02535221

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

Randomized Trial of Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With Estrogen Receptor-Positive HER2 Negative Breast Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 234 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: Female
• Age: 35 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-07-29
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2015-08-28
• Last updated: 2021-11-29

Locations

1 site across 1 country: China