Status:
COMPLETED
Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine
Lead Sponsor:
Pfizer
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ther...
Eligibility Criteria
Inclusion
- 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
- Prior treatment with another topoisomerase I inhibitor
- Current enrollment in another clinical trial
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00072852
Start Date
November 1 2003
End Date
May 1 2007
Last Update
October 16 2008
Active Locations (66)
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1
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
2
Pfizer Investigational Site
Anchorage, Alaska, United States, 99508
3
Pfizer Investigational Site
Lewistown, Idaho, United States, 83501
4
Pfizer Investigational Site
Alton, Illinois, United States, 62002