drugset / Trial / NCT00194753

Adjuvant Therapy for High-Risk Breast Cancer With Wkly Adriamycin & Oral Cytoxan With G-CSF for 12 Wks; Wkly Taxol x 12

NCT00194753 ↗

NaSingle-groupOpen-labelTreatment

Summary

The primary objectives of the study are to evaluate the feasibility and toxicity of treatment with 12 weeks of Adriamycin with daily oral Cytoxan with G-CSF support followed by 12 weeks of Taxol. Feasibility will be assessed by comparing the delivered dose intensity of each drug to the delivered dose intensity in previous trials. Toxicity will be assessed by comparing the incidence and severity of toxicity with these drugs to previous trials using these drugs in the same combination. We hypothesize metronomic, dose dense treatment as given in this study will be less toxic and more effective than historical regimens using the same drugs in a less metronomic, dose dense manner.

Timeline

Start
2001-12
Primary completion
2011-03
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 60 mg/m2 Oral
Subject Doxorubicin Other / unclassified 24 mg/m2 Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous

Indications