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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior treatment with another topoisomerase I inhibitor

- Current enrollment in another clinical trial

NCT00072852
Pfizer
Completed
Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine

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Similar Trials

Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine
Phase II Trial of Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasms
Drug: Irinotecan
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
134
May 2007
May 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Colombia,   New Zealand,   United States
 
 
NCT00072852
CPTAPO-0047-146
A5961023
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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