Intensive Combo Chemo With Autologous BM Rescue for Metastatic Breast Cancer
Phase 2
Completed
- Conditions
- Metastatic Breast Cancer
- Interventions
- Procedure: High-dose chemotherapy
- Registration Number
- NCT00584766
- Lead Sponsor
- University of Oklahoma
- Brief Summary
To determine the therapeutic efficacy of high-dose cyclophosphamide and BCNU with autologous bone marrow transplantation after initial tumor cytoreduction for patients with receptor-negative metastatic breast carcinoma and to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast carcinoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 21
Inclusion Criteria
- breast carcinoma at first clinical evidence of metastatic disease
- must have measurable disease by physical exam, x-ray, or scan
- Age < or equal to 55
- performance status 0-2
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Exclusion Criteria
- can't have had more than one prior chemotherapy regimen
- can't have had concurrent hormonal therapy
- no brain metastases
- no previous pelvic radiation
- no history of another malignancy
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 High-dose chemotherapy -
- Primary Outcome Measures
Name Time Method Quality of maximal response; time to initial disease progression; and overall survival undetermined
- Secondary Outcome Measures
Name Time Method to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast cancer undetermined
Trial Locations
- Locations (1)
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States