Trastuzumab and Irinotecan in Treating Patients With HER2/Neu Positive Metastatic Breast Cancer
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.
Drug: irinotecan hydrochloride
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Weekly Trastuzumab (Herceptin) and Irinotecan in Patients With HER-2 Positive Advanced Breast Cancer: A Phase II Trial|
- Overall objective response rate (partial and complete responses) [ Time Frame: up to 20 months post treatment ] [ Designated as safety issue: No ]
- Stable disease rate [ Time Frame: up to 20 months post treatment ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: up to 20 months post treatment ] [ Designated as safety issue: Yes ]
- Duration of response [ Time Frame: up to 20 months post treatment ] [ Designated as safety issue: No ]
- Time to disease progression [ Time Frame: up to 20 months post treatment ] [ Designated as safety issue: No ]
- Development of brain metastases or progression of known metastases on this treatment [ Time Frame: up to 20 months post treatment ] [ Designated as safety issue: No ]
|Study Start Date:||May 2004|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Experimental: Trastuzumab and Irinotecan||Biological: trastuzumab Drug: irinotecan hydrochloride|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303992
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115-1710|
|Principal Investigator:||Hope S. Rugo, MD||University of California, San Francisco|
|Principal Investigator:||Judy M. Cheng, MD, PhD||University of California, San Francisco|