Status:

WITHDRAWN

Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast Cancer

Lead Sponsor:

Pfizer

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief Summary

This study will assess the effectiveness of CP- 751,871 when given in combination with docetaxel to women with the first occurrence of advanced breast cancer disease. The effectiveness will be measure...

Eligibility Criteria

Inclusion

  • histologically or cytologically confirmed diagnosis with evidence of either metastatic disease (Stage IV) of locally recurrent disease not amenable to curative resection or radiation therapy (Stage IIIB).
  • Her-2negative breast cancer or unknown Her-2 status.
  • at least 1 measurable lesion as defined by RECIST.
  • ECOG status 0-1
  • adequate bone marrow, hepatic and renal function.
  • left ventricular ejection fraction of greater than or equal to 50%.
  • willingness to discontinue hormonal therapy.

Exclusion

  • any previous chemotherapy for advanced disease.
  • prior exposure to taxanes as (neo) adjuvant treatment less than 12 months prior to randomization.
  • symptomatic brain metastases.
  • prior anti-IGF-1R based investigational therapy.
  • peripheral neuropathy greater than grade 2.

Key Trial Info

Start Date :

April 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2011

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00678626

Start Date

April 1 2009

End Date

September 1 2011

Last Update

May 4 2015

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Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast Cancer | DecenTrialz