Randomized Phase II Trial of Dose Dense Docetaxel in N+ Breast Cancer
NCT00189670 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2005-09-19
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 were included.
Conditions
- Node Positive Breast Cancer
Interventions
- PROCEDURE
-
6 TEC q 3 weeks
- PROCEDURE
-
4 EC q 2 weeks followed by 4 TXT q 2 weeks
- PROCEDURE
-
4 TXT q 2 weeks followed by 4 EC q 2 weeks
Sponsors & Collaborators
-
Aventis Pharmaceuticals
collaborator INDUSTRY - collaborator INDUSTRY
-
Association Européenne de Recherche en Oncologie
lead OTHER
Principal Investigators
-
Pascal Piedbois, MD, PhD · Association Europeenne de Recherche en Oncologie
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
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