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Phase II Study of Docetaxel Combined With Ketoconazole in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer Patients With Measurable Primary Breast Tumor
Patients with locally advanced or metastatic breast cancer and with measurable primary breast tumor will be treated with 70mg docetaxel combined with ketoconazole. Serial tumor biopsies and plasma samples will be taken for gene expression and proteomics studies to identify biomarkers that may predict for treatment response.
Details
| Lead sponsor | National University Hospital, Singapore |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 30 |
| Start date | 2005-06 |
| Completion | 2012-06 |
Conditions
- Metastatic Breast Cancer
Interventions
- docetaxel and ketoconazole
Primary outcomes
- 1. Evaluate the clinical response rate of 70mg docetaxel with ketoconazole in metastatic breast cancer. — 4 months
- 2. Evaluate the pathological response rate in the primary tumor following four cycles of docetaxel and ketoconazole. — 5 months
Countries
Singapore