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
1 other identifier
interventional
N/A
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2009
Shorter than P25 for phase_2 breast-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2008
CompletedFirst Posted
Study publicly available on registry
May 15, 2008
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedMay 4, 2015
April 1, 2015
2.4 years
May 12, 2008
April 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
3 years
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Arm A
EXPERIMENTALcombination of CP-751,871 + docetaxel administered
Arm B
ACTIVE COMPARATORchemotherapy
Interventions
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.
Docetaxel only is administered every 3 weeks. After progression, administration with CP-751, 871 (20 mg/kg IV) is permitted.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 12, 2008
First Posted
May 15, 2008
Study Start
April 1, 2009
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
May 4, 2015
Record last verified: 2015-04