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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 June 2015 |
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Main ID: |
NCT02450058 |
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Date of registration:
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14/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Adjuvant FEC Versus EP in Breast Cancer (MIG5)
MIG5 |
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Scientific title:
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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 |
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Date of first enrolment:
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November 1996 |
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Target sample size:
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1055 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02450058 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Italy
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Contacts
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Name:
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Lucia Del Mastro, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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IRCCS San Martino - IST, Istituto Nazionale per la Ricerca sul Cancro, Genoa |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Chemotherapy, Adjuvant
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Intervention(s)
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Drug: cyclophosphamide
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Drug: paclitaxel
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Drug: 5-fluorouracil
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Drug: epirubicin
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Primary Outcome(s)
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overall survival
[Time Frame: within 11 years since the enrolment of the 1st patient]
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Secondary Outcome(s)
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event free survival
[Time Frame: within 11 years since the enrolment of the 1st patient]
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toxicity as measured according to the World Health Organization Criteria
[Time Frame: within the first 30 days after the end of chemotherapy]
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Secondary ID(s)
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OMI96.018
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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