NCT02450058

Adjuvant FEC Versus EP in Breast Cancer (MIG5)

Fluorouracil, Epirubicin and Cyclophosphamide Versus Concurrent Epirubicin and Paclitaxel in Node Positive Early Breast Cancer Patients: a Randomized, Phase III Trial of Gruppo Oncologico Nord-Ovest - Mammella Intergruppo Group

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,055 (actual)
• Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

At the time the Gruppo Oncologico Nord-Ovest- Mammella Intergruppo trial 5 (GONO-MIG5) was designed in 1996, paclitaxel was known to have efficacy in patients with advanced breast cancer, but its role was still to be established in the adjuvant setting. Therefore the GONO-MIG5 trial was designed to compare a standard anthracycline-containing chemotherapy regimen, i.e. 5fluorouracil, epirubicin, ciclophosphamide (FEC), given for 6 cycles to a new regimen containing both epirubicin and paclitaxel (EP), given concurrently, for 4 cycles. This latter regimen was chosen on the basis of the results obtained in metastatic breast cancer patients, where the combination of doxorubicin and paclitaxel was associated with more than 90% of objective response . Only four cycles of the new regimen were planned since the expected toxicity, particularly the cardiotoxicity, was high, and a short treatment duration was hoped to be the best strategy to obtain a favourable balance between the toxicity and the expected high efficacy.

Conditions

• Breast Cancer
• Chemotherapy, Adjuvant

Interventions

Type	Name	Description
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

Timeline

• Start date: 1996-11-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2015-05-21
• Last updated: 2015-05-21

Locations

8 sites across 1 country: Italy