Validation of genetic diagnosis to predict sensitivity in primary systemic chemotherapy with paclitaxel in women with breast cancer
Phase 3
- Conditions
- Breast cancer
- Registration Number
- JPRN-C000000413
- Lead Sponsor
- Cancer Institute Hospital, Japanese Foundation for Cancer Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 109
Inclusion Criteria
Not provided
Exclusion Criteria
Non invasive or microinvasive breast cancer. Stage IIIC, IV. Inflammatory breast caner. Male breast cancer. Previously treated with chemotherapy, hormone therapy or radiotherapy. Active double cancer. Serious complication (infection, cardiac disease, pulmonary fibrosis interstitial pneumonitis, bleeding). Hepatitis type B and its carrier. Uncontrolled diabetes. Heavy history of drug allergy. History of allergic reaction to drugs using the vehicle Cremophor. Pregnant, nursing or willing to be pregnant. Inadequate to entry judged by investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Accuracy of prediction system of sensitivity: Elucidate a population of patients who are sensitive to paclitaxel by performing quantitative RT-PCR on about 50 genes before administration of paclitaxel. Evaluate pathological response by paclitaxel in patients who are diagnosed as positive sensitivity and compare those in patients who do not receive sensitivity testing. Improvement of pathological response rate is judged as high accuracy of prediction system for sensitivity
- Secondary Outcome Measures
Name Time Method Examine the influence of genetic diagnosis on pathological complete response rate, clinical response rate, breast conserving rate, disappearance rate of axillary node metastasis, distant-metastasis free survival, disease free survival and overall survival. Examine the association between genetic polymorphism and adverse events by chemotherapy