Breast Neoplasms
Conditions
Keywords
Breast Cancer, Cancer Treatment, Breast Cancer Treatment
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
Interventions
PROCEDUREHigh-Dose Chemo with Autologous BMT
Carboplatin/VP-16/Cytoxan for women 18-59 and Carboplatin/Thiotepa/Cytoxan for women 60-70
Sponsors
Stephenson Cancer Center
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Once 10 patients enrolled in the study ar followed for at least 6 months, a preliminary analysis of the data will occur. | Undetermined |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes | Undetermined |
Countries
United States
Outcome results
None listed