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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and efficacy of Irinotecan in refractory breast cancer.

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

CPTAPO-0047-146

NCT ID:

NCT00072852

Start Date:

November 2003

Completion Date:

May 2007

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteKansas City, Kansas  66112
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteBartlesville, Oklahoma  74006
Pfizer Investigational SiteEasley,, South Carolina  29640
Pfizer Investigational SiteShreveport, Louisiana  71103
Pfizer Investigational SiteMilwaukee, Wisconsin  53215
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteOlive Branch, Mississippi  38654
Pfizer Investigational SiteLivingston, New Jersey  07039
Pfizer Investigational SiteAnchorage, Alaska  99508
Pfizer Investigational SiteLewistown, Idaho  83501