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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00072852 |
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Date of registration:
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11/11/2003 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine
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Scientific title:
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Phase II Trial of Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine |
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Date of first enrolment:
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November 2003 |
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Target sample size:
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134 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00072852 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Argentina
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Australia
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Colombia
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New Zealand
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Neoplasms
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Intervention(s)
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Drug: Irinotecan
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Primary Outcome(s)
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To evaluate the safety and efficacy of Irinotecan in refractory breast cancer.
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Secondary ID(s)
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A5961023
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CPTAPO-0047-146
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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