Metastatic Breast Cancer
Conditions
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
Interventions
PROCEDUREHigh-dose chemotherapy
Cyclophosphamide 500 mg/m2 IV day 1; Doxorubicin 30 mg/m2 IV Day 1; Methotrexate 300 mg/m2 IV Day 8;5-FU 500 mg/m2 IV day 8; leucovorin 20 mg po q 6 h x 6 doses, day 9- cycles repeated q 21 days
Sponsors
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of maximal response; time to initial disease progression; and overall survival | undetermined |
Secondary
| Measure | Time frame |
|---|---|
| to determine the optimal timing of CyBCNU-ABMT after initial development of metastatic breast cancer | undetermined |
Countries
United States
Outcome results
None listed