NCT00309569

Randomized Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment in Receptor-negative Patients

A Randomized Phase III Study Comparing Pre- and Postoperative vs. Conventional Adjuvant Treatment Hormone Receptor-negative Breast Cancer Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 429 (actual)
• Sponsor: Austrian Breast & Colorectal Cancer Study Group · Network
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Primarily, this clinical investigation compared overall survival and recurrence-free survival in patients with hormone receptor-negative breast cancer treated with pre- and postoperative chemotherapy vs. conventional postoperative treatment.

Conditions

• Early Stage Breast Cancer

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Cyclophosphamide 600mg/m2
DRUG	Methotrexate	Methotrexate 40mg/m2
DRUG	Fluorouracil	Fluorouracil 600mg/m2
DRUG	Epirubicin	Epirubucin 60mg/m2 (only node-positive patients)
OTHER	Surgery	Surgery

Timeline

• Start date: 1991-10-01
• Primary completion: 2000-09-01
• Completion: 2000-09-01
• First posted: 2006-04-03
• Last updated: 2020-10-14