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
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