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Trial record 19 of 99 for:    FEC

Adjuvant FEC Versus EP in Breast Cancer (MIG5) (MIG5)

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ClinicalTrials.gov Identifier: NCT02450058
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Lucia Del Mastro,MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

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).

Condition or disease Intervention/treatment Phase
Breast Cancer Chemotherapy, Adjuvant Drug: 5-fluorouracil Drug: epirubicin Drug: cyclophosphamide Drug: paclitaxel Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1055 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 1996
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Epirubicin

Arm Intervention/treatment
Active Comparator: FEC
5-Fluorouracil 600 mg/m2, epirubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, intravenously on day 1, every 21 days
Drug: 5-fluorouracil
600 mg/m2 intravenously on day 1, every 21 days for six cycles

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

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

Active Comparator: EP
Epirubicin 90 mg/m2 and paclitaxel 175 mg/m2, 3-hour infusion on day 1, every 21 days
Drug: epirubicin
90 mg/m2 on day 1, every 21 days for four cycles

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450058


Locations
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Italy
Federico Castiglione
Alba, Italy, 12051
Ornella Garrone
Cuneo, Italy, 12100
Lucia Del Mastro
Genoa, Italy, 16132
Giovanna Cavazzini
Mantova, Italy, 46100
Andrea Michelotti
Pisa, Italy, 56100
Tiziana Scotto
Sassari, Italy, 07100
Antonio Durando
Torino, Italy, 10126
Saverio Danese
Torino, Italy, 10126
Sponsors and Collaborators
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Investigators
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Principal Investigator: Lucia Del Mastro, MD IRCCS San Martino - IST, Istituto Nazionale per la Ricerca sul Cancro, Genoa

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Responsible Party: Lucia Del Mastro,MD, MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier: NCT02450058     History of Changes
Other Study ID Numbers: OMI96.018
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015

Keywords provided by Lucia Del Mastro,MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:
early breast cancer
adjuvant chemotherapy
FEC
paclitaxel

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Fluorouracil
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antimetabolites
Antimetabolites, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors