Validation of genetic diagnosis to predict sensitivity in primary systemic chemotherapy with paclitaxel in women with breast cancer

UMIN ID: C000000413

Registered date:01/05/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 2006/03/01
• Target sample size: 109
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Arm A: Patients do not utilize genetic diagnosis for sensitivity to paclitaxel and receive primary chemotherapy with paclitaxel (Patients are randomized to arm A or B with ratio 1 to 4.)
Arm B: Patients utilize genetic diagnosis for sensitivity to paclitaxel. Patients who are diagnosed as sensitive to paclitaxel receive primary chemotherapy with paclitaxel. Pateints who are diagnosed as insensitive to paclitaxel receive primary chemotherapy with FEC100.(Patients are randomized to arm A or B with ratio 1 to 4.)

Outcome(s)

• Primary Outcome: 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: 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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 70years-old
• Gender: Female
• Exclude 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.

Related Information

• Primary Sponsor: Cancer Institute Hospital, Japanese Foundation for Cancer Research
• Source(s) of Monetary Support: Ministry of Economy, Trade and Industry