Phase II Trial of Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine
Data Collection
Breast Diseases+2
+ Breast Neoplasms
+ Neoplasms
Treatment Study
Summary
Study start date: November 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.134 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 66 locations
Pfizer Investigational Site
Anchorage, United StatesPfizer Investigational Site
Lewistown, United StatesPfizer Investigational Site
Alton, United States