drugset / Trial / NCT02980965

Neoadjuvant Chemo-endocrine Therapy Versus Chemotherapy Alone in ER-positive, HER2-negative Breast Cancer

NCT02980965

Phase 3 Completed 249 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

This was an open-label, randomized controlled trial that aims to compare the efficacy and safety of the concurrent neoadjuvant chemotherapy with endocrine therapy and neoadjuvant chemotherapy alone in ER-positive, HER2-negative breast cancer.

Timeline

Start
2013-05
Primary completion
2017-02
Completion
2017-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Subject Docetaxel Small molecule 80 mg/m2 Intravenous
Subject Docetaxel Small molecule 100 mg/m2 Intravenous
Subject Epirubicin Small molecule 90 mg/m2 Intravenous
Subject Letrozole Other / unclassified 2.5 mg Oral
Subject Leuprolide Other / unclassified Subcutaneous
Subject fluorouracil Small molecule 500 mg/m2 Intravenous
Subject fluorouracil Small molecule 600 mg/m2 Intravenous