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

NCT ID: NCT00072852

Last Updated: 2008-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2007-05-31

Brief Summary

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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

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Irinotecan

Intervention Type DRUG

Eligibility 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Mobile, Alabama, United States

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Anchorage, Alaska, United States

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Lewistown, Idaho, United States

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Alton, Illinois, United States

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Indianapolis, Indiana, United States

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Overland Park, Kansas, United States

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Chalmette, Louisiana, United States

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Covington, Louisiana, United States

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Mandeville, Louisiana, United States

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Metairie, Louisiana, United States

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Metairie, Louisiana, United States

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New Orleans, Louisiana, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Southaven, Mississippi, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Washington, Missouri, United States

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New Brunswick, New Jersey, United States

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New Brunswick, New Jersey, United States

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New York, New York, United States

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Stony Brook, New York, United States

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Kettering, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Greenville, South Carolina, United States

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Covington, Tennessee, United States

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Franklin, Tennessee, United States

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Gallatin, Tennessee, United States

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Hermitage, Tennessee, United States

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Lebanon, Tennessee, United States

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Memphis, Tennessee, United States

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Murfreesboro, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Plano, Texas, United States

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Tyler, Texas, United States

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Federal Way, Washington, United States

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Lakewood, Washington, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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Vancouver, Washington, United States

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Yakima, Washington, United States

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Milwaukee, Wisconsin, United States

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Capital Federal, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Santa Fe, Santa Fe Province, Argentina

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Capital Federal, , Argentina

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South Brisbane, Queensland, Australia

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Frankston, Victoria, Australia

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Bogotá, Bogota DC, Colombia

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Wellington, , New Zealand

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Countries

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United States Argentina Australia Colombia New Zealand

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=CPTAPO-0047-146&StudyName=Irinotecan%20in%20Patients%20with%20Advanced%20Metastatic%20Breast%20Cancer%20Who%20Have%20Experienced%20Failure%20of%20an%20Anthracycline%2C%20a%20Taxane%2C%20and%20C

To obtain contact information for a study center near you, click here.

Other Identifiers

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A5961023

Identifier Type: -

Identifier Source: secondary_id

CPTAPO-0047-146

Identifier Type: -

Identifier Source: org_study_id