High Dose Chemo With Autologous BMT for Treatment of Metastatic Breast Cancer
Not Applicable
Completed
- Conditions
- Breast Neoplasms
- Interventions
- Procedure: High-Dose Chemo with Autologous BMT
- Registration Number
- NCT00584428
- Lead Sponsor
- University of Oklahoma
- Brief Summary
To evaluate the response rate and the response duration of high dose chemotherapy with autologous bone marrow transplantation as intensification following induction chemotherapy in metastatic breast cancer and to evaluate prospectively the subdivision of patients with metastatic breast cancer according to prognostic groups.
- Detailed Description
There are 2 phases to this study: 1) Induction- which consists of the administration of chemotherapeutic drugs- at the end of this phase if the cancer has responded, bone marrow will be collected and frozen untol ready for re-infusion; 2) 2nd phase- involves high-doses of chemotherapy followed by infusion of bone marrow cells
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 61
Inclusion Criteria
- Histologically confirmed diagnosis of breast cancer
- Age 18-70
- Breast cancer at first clinical evidence of metastatic disease
- Must have objectively measurable or evaluable disease or be in complete remission
Exclusion Criteria
- Previous diagnosis of another invasive carcinaom within 10 years (except skin cancer)
- CNS involvement
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 High-Dose Chemo with Autologous BMT -
- Primary Outcome Measures
Name Time Method Once 10 patients enrolled in the study ar followed for at least 6 months, a preliminary analysis of the data will occur. Undetermined
- Secondary Outcome Measures
Name Time Method No secondary outcomes Undetermined
Trial Locations
- Locations (1)
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States