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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: CP-751,871
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>combination of CP-751,871 + docetaxel administered | Drug: CP-751,871<br>* Docetaxel administered every 3 weeks. CP-751,871 administered every 3 weeks. CP-751,871 administration (20 mg/kg IV) will continue after the docetaxel is stopped.<br>|
| Active Comparator: Arm B<br>chemotherapy | Drug: Docetaxel<br>* Docetaxel only is administered every 3 weeks. After progression, administration with CP-751, 871 (20 mg/kg IV) is permitted.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers (IGF-1R positive Circulating Tumor Cells; Anti-Drug Antibodies) |  | 3 years | 
| Overall Response |  | 3 years | 
| Overall Survival |  | 3 years | 
| Safety and tolerability |  | 3 years | 
| Patient Reported Outcomes using the MDASI (MD Anderson Symptom Inventory) questionnaire |  | 3 years | 
| Pharmacokinetics of CP-751,871 |  | 3 years | 
| Optional tissue markers of the IGF-1R pathway from tumor tissue obtained |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Key words: Docetaxel; breast cancer; breast diseases; breast neoplasms; antineoplastic agents; neoplasms;HER-2 negative; Stage IIIB or IV breast cancer.