Adjuvant FEC Versus EP in Breast Cancer (MIG5)

NCT02450058 | Completed Phase 3

• 1 other identifier: OMI96.018
• Study Type: interventional
• Target: 1,055
• Locations: 1 country
• Sites: 8

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).

Conditions

Breast Cancer; Chemotherapy, Adjuvant

Keywords

early breast cancer; adjuvant chemotherapy; FEC; paclitaxel

Outcome Measures

Primary Outcomes (1)

• overall survival

  estimated from the date of randomization to the date of death from any cause

  within 11 years since the enrolment of the 1st patient

Secondary Outcomes (2)

• event free survival

  within 11 years since the enrolment of the 1st patient

• toxicity as measured according to the World Health Organization Criteria

  within the first 30 days after the end of chemotherapy

Study Arms (2)

FEC

ACTIVE COMPARATOR

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

Drug: 5-fluorouracil; Drug: epirubicin; Drug: cyclophosphamide

EP

ACTIVE COMPARATOR

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

Drug: epirubicin; Drug: paclitaxel

Interventions

5-fluorouracil DRUG

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

FEC

epirubicin DRUG

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

FEC

cyclophosphamide DRUG

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

FEC

paclitaxel DRUG

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

EP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (8)

Federico Castiglione

Alba, 12051, Italy

Location

Ornella Garrone

Cuneo, 12100, Italy

Location

Lucia Del Mastro

Genoa, 16132, Italy

Location

Giovanna Cavazzini

Mantova, 46100, Italy

Location

Andrea Michelotti

Pisa, 56100, Italy

Location

Tiziana Scotto

Sassari, 07100, Italy

Location

Antonio Durando

Torino, 10126, Italy

Location

Saverio Danese

Torino, 10126, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fluorouracil; Epirubicin; Cyclophosphamide; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Lucia Del Mastro, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 21, 2015
• Study Start: November 1, 1996
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

IT (8)