A Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced Breast Cancer.
Phase 2
Withdrawn
- Conditions
- Breast Neoplasms
- Registration Number
- NCT00471159
- Lead Sponsor
- Pfizer
- Brief Summary
To assess the efficacy and safety of PF-3512676 administered in combination with docetaxel for the treatment of patients with advanced breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
- Female patients with confirmed advanced breast cancer.
- Patients with HER-2 negative disease with documented disease progression after (neo)adjuvant treatment with an anthracycline-based chemotherapy regimen.
- Patients with adequate general well-being, kidney and liver function.
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Exclusion Criteria
- Patients that have any condition that could affect patients safety, interfere with trial results, or makes the patient inappropriate for inclusion into study.
- Patients who have had prior chemotherapy for advanced breast cancer.
- Patients of child-bearing potential who are unwilling to use contraception.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Progression-free survival Tumor assessment every 6 weeks until disease progression
- Secondary Outcome Measures
Name Time Method Overall objective response rate, duration of response, time to tumor progression - tumor assessment every 6 weeks until disease progression Overall Survival - Patients will be followed for survival Overall safety profile -Targeted questions to patients throughout study, Weekly blood sampling during treatment, every 3 weeks during follow-up, Urine sample every 3 weeks during treatment and follow-up Changes in pain symptoms -Brief Pain Inventory questionnaire every 3 weeks during chemotherapy