Trastuzumab and Irinotecan in Treating Patients With HER2/Neu Positive Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Biological: trastuzumab
- Registration Number
- NCT00303992
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Trastuzumab and Irinotecan trastuzumab - Trastuzumab and Irinotecan irinotecan hydrochloride -
- Primary Outcome Measures
Name Time Method Overall objective response rate (partial and complete responses) up to 20 months post treatment Stable disease rate up to 20 months post treatment
- Secondary Outcome Measures
Name Time Method Duration of response up to 20 months post treatment Toxicity up to 20 months post treatment Development of brain metastases or progression of known metastases on this treatment up to 20 months post treatment Time to disease progression up to 20 months post treatment
Trial Locations
- Locations (1)
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States