Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine

Completed · Phase 2

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT00072852

Run by

Pfizer

People needed

134

Starts

2003-11-01

Expected to finish

2007-05-01

Last updated by the study team

2008-10-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Prior treatment with another topoisomerase I inhibitor
• Current enrollment in another clinical trial

Where it is running

• Pfizer Investigational Site — Anchorage, Alaska, United States
• Pfizer Investigational Site — Lewistown, Idaho, United States
• Pfizer Investigational Site — Alton, Illinois, United States
• Pfizer Investigational Site — Indianapolis, Indiana, United States
• Pfizer Investigational Site — Overland Park, Kansas, United States
• Pfizer Investigational Site — Chalmette, Louisiana, United States
• Pfizer Investigational Site — Covington, Louisiana, United States
• Pfizer Investigational Site — Mandeville, Louisiana, United States
• Pfizer Investigational Site — Metairie, Louisiana, United States
• Pfizer Investigational Site — Metairie, Louisiana, United States
• Pfizer Investigational Site — New Orleans, Louisiana, United States
• Pfizer Investigational Site — Boston, Massachusetts, United States
• Pfizer Investigational Site — Boston, Massachusetts, United States
• Pfizer Investigational Site — Boston, Massachusetts, United States
• Pfizer Investigational Site — Detroit, Michigan, United States
• Pfizer Investigational Site — Southaven, Mississippi, United States
• Pfizer Investigational Site — Kansas City, Missouri, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — Washington, Missouri, United States
• Pfizer Investigational Site — New Brunswick, New Jersey, United States
• Pfizer Investigational Site — New Brunswick, New Jersey, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Stony Brook, New York, United States
• Pfizer Investigational Site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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