Adjuvant FEC Versus EP in Breast Cancer (MIG5)

Breast Cancer Clinical Trial

— MIG5  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02450058
• Other study ID #: OMI96.018
• Status: Completed
• Phase: Phase 3
• First received: May 14, 2015
• Last updated: May 18, 2015
• Start date: November 1996
• Est. completion date: May 2012

Study information

• Verified date: May 2015
• Source: National Institute for Cancer Research, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1055
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapy, Adjuvant

Intervention

Drug:
• 5-fluorouracil
600 mg/m2 intravenously on day 1, every 21 days for six cycles
• epirubicin
60 mg/m2 intravenously on day 1, every 21 days for six cyles
• cyclophosphamide
600 mg/m2, intravenously on day 1, every 21 days for six cycles
• epirubicin
90 mg/m2 on day 1, every 21 days for four cycles
• paclitaxel
175 mg/m2, 3-hour infusion on day 1, every 21 days for four cycles

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
National Institute for Cancer Research, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	event free survival	from the date of randomization to the date of local recurrence, distant metastases, second primary cancer, or death from any cause	within 11 years since the enrolment of the 1st patient	No
Secondary	toxicity as measured according to the World Health Organization Criteria		within the first 30 days after the end of chemotherapy	Yes