A Research Study of CP-724,714 in Patients With HER2 Overexpressing Metastatic Breast Cancer
The main purpose of this research study is to see if the study drug, named CP-724,714, can help in the treatment of certain breast cancers that have spread to other locations in the body. Other goals of this study are to measure how long it may take for the cancer to get worse (progress), to see if there are any side effects from the study drug, to check the amount of study drug in the blood at different times, and to check to see if there is any relationship between certain blood tests and how patients may respond to the study drug.
About 25 subjects at 4 sites (hospitals and clinics) in Bulgaria and Russia will be involved in the trial. Participation in this study can last up to 48 weeks, depending on the participant's toleration of the study drug and the response of her tumor(s) to the study drug. All participants will receive CP-724,714, at a daily dose of 250 mg (4 pills) every 12 hours.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Multi-Center, Phase 2 Study Of Cp 724,714 In Patients With Her2 Overexpressing Metastatic Breast Cancer That Has Progressed After Chemotherapy For Metastatic Disease And Is Previously Untreated With A Her2 Inhibitor|
- Tumor Response
- Safety/Tolerability and Pharmacokinetics
|Study Start Date:||April 2005|
|Study Completion Date:||September 2005|
Pfizer decided to terminate clinical protocol A4031003 on October 7, 2005 due to the excessive number of patients with grade 3 liver function test elevations and lack of efficacy.