Status:
COMPLETED
Randomized Phase II Trial of Dose Dense Docetaxel in N+ Breast Cancer
Lead Sponsor:
Association Européenne de Recherche en Oncologie
Collaborating Sponsors:
Aventis Pharmaceuticals
Amgen
Conditions:
Node Positive Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
To screen a dose-dense arm to be used in a future large scale phase III trial. Primary endpoint is safety; secondary endpoints are disease free survival and overall survival. A total of 100 patients w...
Eligibility Criteria
Inclusion
- Patient with histologically proven breast cancer
- 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
- Bilateral breast cancer
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00189670
Last Update
September 19 2005
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