Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine
Phase 2
Completed
- Conditions
- Breast Neoplasms
- Registration Number
- NCT00072852
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this phase II, randomized, open-label clinical trial is to study 2 schedules of single-agent Irinotecan in women with metastatic breast cancer who have experienced failure of prior therapy with an anthracycline, a taxane, and capecitabine. Patients will receive Irinotecan capsules either once each day for 5 days, or once a day for 14 days in 3 week cycles.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 134
Inclusion Criteria
- Women with diagnosis of primary adenocarcinoma of the breast
- Presence of locally advanced or metastatic disease non-amenable to surgery or radiation therapy with curative intent
- At least one measurable lesion >20mm (or >10 mm with spiral CT scan)
- Must have received (and failed) prior treatment with an anthracycline, a taxane, and capecitabine in the adjuvant and/or advanced disease treatment setting
- Women at least 18 years old, with performance status 0-2
Exclusion Criteria
- Prior treatment with another topoisomerase I inhibitor
- Current enrollment in another clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To evaluate the safety and efficacy of Irinotecan in refractory breast cancer.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇳🇿Wellington, New Zealand