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Adjuvant FEC Versus EP in Breast Cancer (MIG5)

NCT02450058 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1055

Last updated 2015-05-21

No results posted yet for this study

Summary

In this multicenter, randomized phase III trial, node positive early breast cancer patients are randomly assigned to receive either 6 cycles of FEC (5-fluorouracil 600 mg/m2, epirubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, on day 1, every three weeks) or 4 cycles of EP (epirubicin 90 mg/m2 and paclitaxel 175 mg/m2, on day 1, every three weeks). The primary study endpoint is overall survival (OS). Secondary endpoints include toxicity and event free survival (EFS).

Conditions

Interventions

DRUG

5-fluorouracil

600 mg/m2 intravenously on day 1, every 21 days for six cycles

DRUG

epirubicin

60 mg/m2 intravenously on day 1, every 21 days for six cyles

DRUG

cyclophosphamide

600 mg/m2, intravenously on day 1, every 21 days for six cycles

DRUG

epirubicin

90 mg/m2 on day 1, every 21 days for four cycles

DRUG

paclitaxel

175 mg/m2, 3-hour infusion on day 1, every 21 days for four cycles

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

    lead OTHER

Principal Investigators

  • Lucia Del Mastro, MD · IRCCS San Martino - IST, Istituto Nazionale per la Ricerca sul Cancro, Genoa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
1996-11-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

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 NCT02450058 on ClinicalTrials.gov