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Completed

NCT Number: NCT02450058

Adjuvant FEC Versus EP in Breast Cancer (MIG5)

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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Chemotherapy, Adjuvant Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Federico Castiglione, Alba, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5-fluorouracil

Drug

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

Epirubicin

Drug

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

Cyclophosphamide

Drug

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

paclitaxel

Drug

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

Primary outcomes

  1. overall survival

    Time frame: within 11 years since the enrolment of the 1st patient

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

Secondary outcomes

  1. event free survival

    Time frame: within 11 years since the enrolment of the 1st patient

    from the date of randomization to the date of local recurrence, distant metastases, second primary cancer, or death from any cause

  2. toxicity as measured according to the World Health Organization Criteria

    Time frame: within the first 30 days after the end of chemotherapy

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: MIG5

Important dates

Study start
1996
Primary completion
2012
Study completion
2012
First posted
May 21, 2015
Registry last updated
May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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