Weekly Trastuzumab (Herceptin) and Irinotecan in Patients With HER-2 Positive Advanced Breast Cancer: A Phase II Trial
- 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.
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall objective response rate (partial and complete responses)
up to 20 months post treatment
Hope S. Rugo, MD
University of California, San Francisco
United States: Food and Drug Administration
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|