Status:

TERMINATED

A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

Lead Sponsor:

Pfizer

Conditions:

Breast Neoplasms

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

Brief Summary

To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for ...

Detailed Description

Patient enrollment in this trial was discontinued based on statistical assessment for futility. An independent Data Monitoring Committee found that even if the trial had been allowed to continue, trea...

Eligibility Criteria

Inclusion

  • breast adenocarcinoma
  • prior treatment with an anthracycline and a taxane either concurrently or sequentially in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. No more than 1 chemotherapy regimen in the advanced setting

Exclusion

  • Prior treatment with regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/ taxanes treatments.
  • Any prior regimen with capecitabine

Key Trial Info

Start Date :

November 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2011

Estimated Enrollment :

482 Patients enrolled

Trial Details

Trial ID

NCT00373113

Start Date

November 1 2006

End Date

June 1 2011

Last Update

June 25 2012

Active Locations (123)

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Page 1 of 31 (123 locations)

1

Pfizer Investigational Site

Córdoba, Córdoba Province, Argentina, X5000AAI

2

Pfizer Investigational Site

Bahía Blanca, Prov. de Buenos Aires, Argentina, B8001HXM

3

Pfizer Investigational Site

Viedma, Río Negro Province, Argentina, 8500

4

Pfizer Investigational Site

Rosario, Santa Fe Province, Argentina, (2000)