drugset / Trial / NCT00590785

Phase III Comparison of Adjuvant Chemotherapy W/High-Dose Cyclophosphamide Plus Doxorubicin (AC) vs Sequential Doxorubicin Fol by Cyclophosphamide (A-C) in High Risk Breast Cancer Patients With 0-3 Positive Nodes (Intergroup, CALGB 9394)

NCT00590785

RandomizedParallel-groupOpen-labelTreatment

Summary

To compare disease-free survival (DFS), overall survival (s), and toxicity of high-isk primary breast cancer patients with negative axillary lymph nodes or with one to three positive nodes treated with adjuvant high-dose chemotherapy with doxorubicin plus cyclophosphamide (AC), versus high-dose sequential chemotherapy with doxorubicin followed by cyclophosphamide (A--\>C).

Timeline

Start
1996-08-13
Primary completion
1997-06-10
Completion
2015-01-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified
Subject Doxorubicin Other / unclassified
Background Ciprofloxacin Small molecule
Background G-CSF Unknown
Background Tamoxifen Small molecule 20 mg

Indications