Breast Cancer Clinical Trial
Official title:
HIGH-DOSE CHEMOTHERAPY WITH CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CARBOPLATIN FOLLOWED BY RESCUE WITH AUTOLOGOUS BONE MARROW AND AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH POOR PROGNOSIS BREAST CANCER
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining peripheral stem cell transplantation with
combinations of drugs may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of high-dose combination chemotherapy
followed by peripheral stem cell transplantation or autologous bone marrow transplantation
in women with stage II breast cancer with eight or more positive axillary lymph nodes and in
women with stage III or metastatic breast cancer.
OBJECTIVES: I. Investigate the curative potential of high-dose cyclophosphamide, etoposide,
and carboplatin followed by autologous stem cell rescue in women with breast cancer
considered incurable by conventional therapy. II. Observe the overall response rate,
survival rate, and toxicity associated with this regimen.
OUTLINE: Prior to therapy, patients undergo collection of peripheral blood stem cells (PBSC)
on another protocol; patients with marrow involvement undergo PBSC harvest only, while all
others may also undergo bone marrow harvest. All patients receive cyclophosphamide,
etoposide, and carboplatin over 4 consecutive days, followed 3 days later by PBSC or bone
marrow and granulocyte colony-stimulating factor. Patients are followed for duration of
remission and survival.
PROJECTED ACCRUAL: 100-200 patients will be entered.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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