Breast Cancer Clinical Trial
Official title:
Autotransplantation and Her 2 Neu Antibody Immunotherapy in Advanced Breast Cancer
RATIONALE: Chemotherapy uses different ways to stop tumor cells from dividing so they stop
growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow
the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal
antibodies such as trastuzumab can locate tumor cells and either kill them or deliver
tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and peripheral stem cell
transplantation followed by trastuzumab in treating women who have metastatic breast cancer.
OBJECTIVES: I. Determine the safety and toxicity profile, specifically cardiac toxicity, of
trastuzumab (Herceptin) following high dose chemotherapy and autologous peripheral blood stem
cell transplantation in women with metastatic breast cancer. II. Determine the time to
disease progression and disease free survival in these patients when treated with this
regimen. III. Determine the impact of trastuzumab (Herceptin) on minimal residual disease
after autologous peripheral blood stem cell transplantation as evidenced by serial
immunocytochemical analysis of bone marrow. IV. Determine the relationship between
posttransplant reconstitution of antibody dependent cellular toxicity and the efficacy of
trastuzumab (Herceptin) in these patients.
OUTLINE: This is a multicenter study. Patients undergo stem cell mobilization with growth
factors alone (filgrastim (G-CSF) and/or sargramostim (GM-CSF)) or chemotherapy followed by
growth factors (depending on center). Peripheral blood stem cells (PBSC) are then collected
by leukapheresis. Patients then receive high dose chemotherapy consisting of cyclophosphamide
IV over 1 hour and cisplatin IV over 72 hours on days -6 to -4 and carmustine IV on day -3 or
cyclophosphamide IV, thiotepa IV, and carboplatin IV over 96 hours on days -7 to -4
(depending on center). PBSC are reinfused on day 0. Patients then receive trastuzumab IV over
30-90 minutes weekly for 1 year or until disease progression beginning 5-8 weeks after PBSC
reinfusion.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
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