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)
Phase 3
Completed
- Conditions
- Breast CancerCyclophosphamideHigh RiskDoxorubicinPositive Nodes
- Interventions
- Registration Number
- NCT00590785
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 G-CSF - 1 Doxorubicin - 1 Cyclophosphamide - 1 G-CSF - 1 tamoxifen - 2 Cyclophosphamide - 2 Doxorubicin - 2 ciprofloxacin -
- Primary Outcome Measures
Name Time Method 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. Conclusion of the study
- Secondary Outcome Measures
Name Time Method To obtain tumor tissue for biologic studies. The details of these biologic studies will be described in a companion protocol or protocols to be developed through the Intergroup mechanism. Conclusion of study
Trial Locations
- Locations (1)
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center🇺🇸New York, New York, United States