Breast Cancer Clinical Trial
Official title:
Weekly Trastuzumab (Herceptin) and Irinotecan in Patients With HER-2 Positive Advanced Breast Cancer: A Phase II Trial
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as
irinotecan, work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing. Giving trastuzumab together with irinotecan may kill
more tumor cells.
PURPOSE: This phase II trial is studying how well giving trastuzumab together with irinotecan
works in treating patients with HER2/neu positive metastatic breast cancer.
OBJECTIVES:
Primary
- Determine the overall objective response-rate (partial and complete) and stable disease
rate in patients with HER2/neu positive metastatic breast cancer treated with the
combination of irinotecan hydrochloride and trastuzumab (Herceptin®) after prior first-
or second-line therapy with trastuzumab combined with other chemotherapeutic agents.
Secondary
- Determine the toxicities of this combination regimen.
- Determine the duration of response and time to disease progression in patients treated
with this combination.
- Document development of brain metastases or progression of known metastases in patients
treated with this regimen.
OUTLINE: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, 15,
and 22 and irinotecan hydrochloride IV over 30-60 minutes on days 1, 8, and 15. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
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