drugset / Trial / NCT02535221

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

NCT02535221

Phase 3 Recruiting 234 enrolled Peking University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-07-29
Primary completion
2026-06-30
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Anastrozole Other / unclassified 1 mg Oral
Comparator CTX Unknown 600 mg/m2
Comparator Epirubicin Small molecule 80 mg/m2
Comparator Epirubicin Small molecule 100 mg/m2
Subject Goserelin Other / unclassified 3.6 mg Subcutaneous
Subject Tamoxifen Small molecule 10 mg Oral
Comparator fluorouracil Small molecule 200 mg/m2
Comparator fluorouracil Small molecule 600 mg/m2

Indications