Adjuvant FEC Versus EP in Breast Cancer (MIG5)

NCT ID: NCT02450058

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1055 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-11-30
• Study Completion Date: 2012-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FEC

5-Fluorouracil 600 mg/m2, epirubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, intravenously on day 1, every 21 days

Group Type: ACTIVE_COMPARATOR

5-fluorouracil

Intervention Type: DRUG

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

epirubicin

Intervention Type: DRUG

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

cyclophosphamide

Intervention Type: DRUG

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

EP

Epirubicin 90 mg/m2 and paclitaxel 175 mg/m2, 3-hour infusion on day 1, every 21 days

Group Type: ACTIVE_COMPARATOR

epirubicin

Intervention Type: DRUG

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

paclitaxel

Intervention Type: DRUG

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

Interventions

5-fluorouracil

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

Intervention Type: DRUG

epirubicin

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

Intervention Type: DRUG

cyclophosphamide

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

Intervention Type: DRUG

epirubicin

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

Intervention Type: DRUG

paclitaxel

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Women with histologically confirmed breast cancer who had undergone radical mastectomy or breast-conserving surgery in addition to full ipsilateral axillary lymph node dissection
• Lymph node-positive disease with less than 10 involved axillary lymph nodes
• Surgery performed not more than 5 weeks before randomization
• ECOG performance status 0
• Absolute neutrophil count ≥ 2,000/mm³
• WBC ≥ 3,000/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 1.5 times ULN
• Postoperative regional radiotherapy limited to the remaining breast admitted for patients who received breast-conserving surgery
• Written informed consent

Exclusion Criteria

• Prior or concurrent ipsilateral or contralateral invasive breast carcinoma within the last 10 years
• Metastatic disease, including metastasis in the ipsilateral supraclavicular lymph nodes
• Prior chemotherapy or prior cytotoxic regimens or prior hormonal therapy
• Pregnant or nursing
• Other serious medical illness requiring medication, uncontrolled infections
• Other malignancy except adequately treated, cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
• Recent myocardial infarction, congestive heart failure, or serious arrhythmia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Lucia Del Mastro,MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucia Del Mastro, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Martino - IST, Istituto Nazionale per la Ricerca sul Cancro, Genoa

Locations

Federico Castiglione

Alba, , Italy

Ornella Garrone

Cuneo, , Italy

Lucia Del Mastro

Genoa, , Italy

Giovanna Cavazzini

Mantova, , Italy

Andrea Michelotti

Pisa, , Italy

Tiziana Scotto

Sassari, , Italy

Antonio Durando

Torino, , Italy

Saverio Danese

Torino, , Italy

Countries

Italy

Other Identifiers

OMI96.018

Identifier Type: -

Identifier Source: org_study_id