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

Pfizer

Status and phase

Withdrawn

Phase 2

Conditions

Breast Cancer

Treatments

Drug: CP-751,871

Drug: Docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00678626

A4021008

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.