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

NCT00309569 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 429

Last updated 2020-10-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Austrian Breast & Colorectal Cancer Study Group

    lead NETWORK

Principal Investigators

  • Raimund Jakesz, MD · Austrian Breast & Colorectal Cancer Study Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1991-10-31
Primary Completion
2000-09-30
Completion
2000-09-30

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00309569 on ClinicalTrials.gov