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

A Randomized Phase 2, Open-Label Study Of CP-751,871 In Combination With Docetaxel And Docetaxel Alone As A First Line Treatment Of Patients With Advanced Breast Cancer

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 measured by progression-free survival duration. Patients will be followed for 2 years from the date of randomization.

Inclusion Criteria:

• 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 Criteria:

• 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.