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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 Site Birmingham, Alabama  35205
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Cincinnait, Ohio  45236
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site Carmel, Indiana  46032
Pfizer Investigational Site Kansas City, Kansas  66112
Pfizer Investigational Site North Adams, Massachusetts  01247
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Bartlesville, Oklahoma  74006
Pfizer Investigational Site Easley,, South Carolina  29640
Pfizer Investigational Site Shreveport, Louisiana  71103
Pfizer Investigational Site Milwaukee, Wisconsin  53215
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Olive Branch, Mississippi  38654
Pfizer Investigational Site Livingston, New Jersey  07039
Pfizer Investigational Site Anchorage, Alaska  99508
Pfizer Investigational Site Lewistown, Idaho  83501