Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast Cancer
- Registration Number
- NCT00678626
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A CP-751,871 combination of CP-751,871 + docetaxel administered Arm B Docetaxel chemotherapy
- Primary Outcome Measures
Name Time Method Progression Free Survival 3 years
- Secondary Outcome Measures
Name Time Method Patient Reported Outcomes using the MDASI (MD Anderson Symptom Inventory) questionnaire 3 years Overall Response 3 years Biomarkers (IGF-1R positive Circulating Tumor Cells; Anti-Drug Antibodies) 3 years Overall Survival 3 years Optional tissue markers of the IGF-1R pathway from tumor tissue obtained 3 years Safety and tolerability 3 years Pharmacokinetics of CP-751,871 3 years
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie CP-751,871's synergy with docetaxel in HER2-negative advanced breast cancer?
How does the PI3K/AKT/mTOR pathway inhibition by CP-751,871 compare to other targeted therapies in combination with taxanes for metastatic breast cancer?
Which biomarkers correlate with improved progression-free survival in patients receiving CP-751,871 plus docetaxel versus docetaxel monotherapy in first-line advanced breast cancer treatment?
What are the most common adverse events associated with CP-751,871 and docetaxel combination therapy in hormone receptor-positive breast cancer patients?
How does the efficacy of CP-751,871/docetaxel compare to other dual-targeted therapy combinations like everolimus plus paclitaxel in advanced breast cancer?