Status:
COMPLETED
Dose-Dense Docetaxel Before or After Doxorubicin/Cyclophosphamide in Axillary Node-Positive Breast Cancer
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This study will determine if docetaxel will be administered before or after doxorubicin/cyclophosphamides in an adjuvant chemotherapy regimen to be evaluated in a subsequent phase III trial.
Detailed Description
Rationale: Studies suggest that chemotherapy agents docetaxel, doxorubicin, and cyclophosphamide have some efficacy against different types of breast cancer. However, the optimal sequence in which to ...
Eligibility Criteria
Inclusion
- Must have histologically or cytologically confirmed breast cancer
- No metastatic disease
- Prior lumpectomy or mastectomy
- No prior chemotherapy or hormone treatments for breast cancer
- Must have normal organ and marrow function.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Exclusion
- Peripheral neuropathy of grade II or higher.
- History or evidence upon physical exam of CNS (central nervous system Diseases)disease.
- History of unstable angina or myocardial infarction within the last six months.
- Pregnant or nursing women.
- Known allergies to polysorbate 80.
- HIV-positive patients.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00201708
Start Date
October 1 2004
End Date
February 1 2014
Last Update
September 2 2016
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210