Breast CancerPhase 3MIG5NCT02450058
Adjuvant FEC Versus EP in Breast Cancer (MIG5)
A Phase 3 study testing 5-fluorouracil, epirubicin and cyclophosphamide in people with Breast Cancer and Chemotherapy, Adjuvant, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 8 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy, Adjuvant
- What is being tested?
- 5-fluorouracil, epirubicin and cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,055 participants
- Where
- 8 sitesItaly
- Study dates
- Nov 1996to May 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Federico Castiglione
Alba, 12051
Ornella Garrone
Cuneo, 12100
Lucia Del Mastro
Genoa, 16132
Giovanna Cavazzini
Mantua, 46100
Andrea Michelotti
Pisa, 56100
Tiziana Scotto
Sassari, 07100
Antonio Durando
Torino, 10126
Saverio Danese
Torino, 10126
About this study
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
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).
Read the 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.
- Conditions
- Breast Cancer, Chemotherapy, Adjuvant
- Being tested
- 5-fluorouracil, epirubicin, cyclophosphamide, paclitaxel
- Keywords
- early breast cancer, adjuvant chemotherapy, FEC, paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-fluorouracilDrug
600 mg/m2 intravenously on day 1, every 21 days for six cycles
epirubicinDrug
60 mg/m2 intravenously on day 1, every 21 days for six cyles
cyclophosphamideDrug
600 mg/m2, intravenously on day 1, every 21 days for six cycles
epirubicinDrug
90 mg/m2 on day 1, every 21 days for four cycles
paclitaxelDrug
175 mg/m2, 3-hour infusion on day 1, every 21 days for four cycles
| Study group | Role | What they receive |
|---|---|---|
| FEC | Active comparator | 5-Fluorouracil 600 mg/m2, epirubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, intravenously on day 1, every 21 days Receives: 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 Receives: Drug: epirubicin; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
estimated from the date of randomization to the date of death from any cause
Measured: within 11 years since the enrolment of the 1st patient
Secondary outcomes (2)
event free survival
from the date of randomization to the date of local recurrence, distant metastases, second primary cancer, or death from any cause
Measured: within 11 years since the enrolment of the 1st patient
toxicity as measured according to the World Health Organization Criteria
Measured: within the first 30 days after the end of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startNov 1996
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,055 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucia Del Mastro,MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Investigators
- Lucia Del Mastro, MD, Principal investigator, IRCCS San Martino - IST, Istituto Nazionale per la Ricerca sul Cancro, Genoa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450058
- Sponsor's protocol ID
- OMI96.018
- Acronym
- MIG5
- Status last verified
- May 2015
- First submitted
- 14 May 2015
- Last updated
- 21 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02450058
- Acronym / sponsor ID
- MIG5 / OMI96.018
- Conditions
- Breast Cancer, Chemotherapy, Adjuvant
- Keywords
- early breast cancer, adjuvant chemotherapy, FEC, paclitaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,055 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyUniversity, hospital or other
- Study start
- Nov 1996
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FEC | Active comparator | Drug: 5-fluorouracil, Drug: epirubicin, Drug: cyclophosphamide5-Fluorouracil 600 mg/m2, epirubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, intravenously on day 1, every 21 days |
| EP | Active comparator | Drug: epirubicin, Drug: paclitaxelEpirubicin 90 mg/m2 and paclitaxel 175 mg/m2, 3-hour infusion on day 1, every 21 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-fluorouracil600 mg/m2 intravenously on day 1, every 21 days for six cycles | Drug | FEC |
| epirubicin60 mg/m2 intravenously on day 1, every 21 days for six cyles | Drug | FEC |
| cyclophosphamide600 mg/m2, intravenously on day 1, every 21 days for six cycles | Drug | FEC |
| epirubicin90 mg/m2 on day 1, every 21 days for four cycles | Drug | EP |
| paclitaxel175 mg/m2, 3-hour infusion on day 1, every 21 days for four cycles | Drug | EP |
Primary outcome
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
2 secondary outcomes
event free survival
Time frame: within 11 years since the enrolment of the 1st patient
toxicity as measured according to the World Health Organization Criteria
Time frame: within the first 30 days after the end of chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucia Del Mastro, MD principal investigator
IRCCS San Martino - IST, Istituto Nazionale per la Ricerca sul Cancro, Genoa
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5-fluorouracil, epirubicin and cyclophosphamide in people with Breast Cancer and Chemotherapy, Adjuvant, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 8 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: within 11 years since the enrolment of the 1st patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2015.