Randomized Phase II Trial of Dose Dense Docetaxel in N+ Breast Cancer
NCT ID: NCT00189670
Last Updated: 2005-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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6 TEC q 3 weeks
4 EC q 2 weeks followed by 4 TXT q 2 weeks
4 TXT q 2 weeks followed by 4 EC q 2 weeks
Eligibility Criteria
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Inclusion Criteria
* Surgical resection performed with clear margins (R0 resection)
* At least 1 histologically proven involved axillary node
* ER + or ER-
* Interval between surgery (2nd surgical procedure in case of multiple procedures) and randomization inferior to 60 days
* Aged over 18 years, and more than 10-year life expectancy
* ECOG performance status 0-1
* Signed informed consent form prior to randomization
Exclusion Criteria
* Inflammatory breast cancer
* Personal history of breast cancer
* Immunohistochemical only node involvement
* Intraductal breast cancer
* Distant metastases
* Contraindication to any drug contained in the chemotherapy regimens
* Any serious active disease or co-morbid medical condition including recent history of severe sepsis and digestive inflammatory disease
* Poor renal function (creatinin level \> 120 micromol/L), poor hepatic function (total bilirubin level \> 1 UNL), transaminases \> 2.5 UNL)
* Poor bone marrow reserve as defined by neutrophils \< 1.5 G/L or platelets \< 100 G/L; Hemoglobin \< 10 G/dL
* Poor contractile cardiac function (LVEF \< 50%)
* Coronary disease
* Any history of cancer during the last 5 years, with the exception of basal cell carcinomas or stage 0 (in situ) cervical carcinoma
* Pregnancy or breast feeding
* Absence of contraception in non menopausal women
* Adult patient unable to give informed consent because of intellectual impairment
* Concomitant participation to another trial
18 Years
FEMALE
No
Sponsors
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Aventis Pharmaceuticals
INDUSTRY
Amgen
INDUSTRY
Association Européenne de Recherche en Oncologie
OTHER
Principal Investigators
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Pascal Piedbois, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Association Europeenne de Recherche en Oncologie
Other Identifiers
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AERO-B03
Identifier Type: -
Identifier Source: org_study_id