Breast CancerPhase 3NCT00189644
6 FEC 100 Vs 4 FEC 100 Followed by 4 Taxol in N+ Breast Cancer
A Phase 3 study testing 6 FEC 100 and 4 FEC 100 followed by 4 Taxol in people with Breast Cancer, run by Association Européenne de Recherche en Oncologie.
Trial summary
The main objective of this randomized trial is to compare 6 FEC100 to 4 FEC100 + 4 Taxol in patients with resected node positive breast cancer. Main endpoint is disease free survival. Secondary endpoints are overall survival, time to local recurrence, time to distant metastases, and tolerance. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 6 FEC 100 and 4 FEC 100 followed by 4 Taxol
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven cancer of the breast,
- Mastectomy or complete tumorectomy,
- Histologically proven homolateral, axillary lymph node involvement (at least 1 N+)
- Period between surgery (second operation in case of primarily incomplete resection) and the start of chemotherapy < 2 months,
- Biological criteria (before the first FEC cycle):
- Neutrophils >1.5 109 /L
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- Platelets >100 109/L
- Hemoglobin >10 g/dl
- Creatininemia <120 mmol/1
- Bilirubinemia <1.5 Upper normal value
- Female patients over 18 years old
- Written and signed informed consent
- Performance Status less than or equal to 2 (WHO scale, see Annex IV)
Who cannot join
- Prior chemotherapy or radiotherapy, including neo-adjuvant treatment for cancer of the breast,
- Bilateral breast cancer or history of contralateral breast cancer
- Cardiac history: cardiac insufficiency (LVEF <50%) or coronary decompensation
- Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential)
- Inflammatory breast cancer
- Distant metastasis or supraclavicular adenopathy
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- Benign pathology or history of malignant pathology accompanied by a life expectancy of less than two years
- Contra-indication to Anthracyclines, Cyclophosphamide, 5FU or Taxol
- Psychiatric pathology
- Patient participating in another trial
About this study
The main objective of this randomized trial is to compare 6 FEC100 to 4 FEC100 + 4 Taxol in patients with resected node positive breast cancer. Main endpoint is disease free survival. Secondary endpoints are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 840 patients have been included in the trial.
- Conditions
- Breast Cancer
- Being tested
- 6 FEC 100, 4 FEC 100 followed by 4 Taxol
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 FEC 100Procedure or surgery
4 FEC 100 followed by 4 TaxolProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
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)
Sponsor and investigators
- Lead sponsor
- Association Européenne de Recherche en Oncologie
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Pascal Piedbois, MD, Principal investigator, Association Europeenne de Recherche en OncologieAnne-Chantal Braud, MD, Principal investigator, Association Europeenne de Recherche en OncologieDaniel Serin, MD, Principal investigator, Association Europeenne de Recherche en Oncologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189644
- Sponsor's protocol ID
- AERO-B2000
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 19 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 6 FEC 100 Vs 4 FEC 100 Followed by 4 Taxol in N+ Breast Cancer
- ClinicalTrials.gov ID
- NCT00189644
- Acronym / sponsor ID
- AERO-B2000
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Association Européenne de Recherche en OncologieUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- First posted
- 19 Sep 2005 (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.
The main objective of this randomized trial is to compare 6 FEC100 to 4 FEC100 + 4 Taxol in patients with resected node positive breast cancer. Main endpoint is disease free survival. Secondary endpoints are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 840 patients have been included in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically proven cancer of the breast,
- Mastectomy or complete tumorectomy,
- Histologically proven homolateral, axillary lymph node involvement (at least 1 N+)
- Period between surgery (second operation in case of primarily incomplete resection) and the start of chemotherapy < 2 months,
- Biological criteria (before the first FEC cycle):
Key exclusion criteria (10 listed)
- Prior chemotherapy or radiotherapy, including neo-adjuvant treatment for cancer of the breast,
- Bilateral breast cancer or history of contralateral breast cancer
- Cardiac history: cardiac insufficiency (LVEF <50%) or coronary decompensation
- Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential)
- Inflammatory breast cancer
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 |
|---|---|---|
| 6 FEC 100 | Procedure or surgery | – |
| 4 FEC 100 followed by 4 Taxol | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2005.
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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.
Pascal Piedbois, MD principal investigator
Association Europeenne de Recherche en Oncologie
Anne-Chantal Braud, MD principal investigator
Association Europeenne de Recherche en Oncologie
Daniel Serin, MD principal investigator
Association Europeenne de Recherche en Oncologie
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 6 FEC 100 and 4 FEC 100 followed by 4 Taxol in people with Breast Cancer, run by Association Européenne de Recherche en Oncologie.
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 13 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 19 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
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 19 Sep 2005.