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

• Status: Withdrawn
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Antibodies, Monoclonal; Docetaxel

Criteria

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.