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
We hypothesize that 70mg docetaxel co-administered with ketoconazole would result in similar
clinical efficacy as conventional doses of docetaxel (75mg/m2 body surface area) in terms of
clinical and pathological response rates in metastatic breast cancer. We further hypothesize
that tumor genomic and proteomic changes and serum proteomic changes would correlate with
tumor response. We are also looking to correlate drug pharmacokinetics with treatment
toxicity, genotype of drug metabolizing enzymes and transporters, and peripheral mononuclear
cell gene expression profiles. The primary objectives are to evaluate the clinical response
rate of 70mg docetaxel with ketoconazole in metastatic breast cancer, and to evaluate the
pathological response rate in the primary tumor following four cycles of docetaxel and
ketoconazole.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
1. Evaluate the clinical response rate of 70mg docetaxel with ketoconazole in metastatic breast cancer.
4 months
Yes
Soo-Chin Lee, MD
Principal Investigator
Consultant
Singapore: Health Sciences Authority
BR01/07/05
NCT00212095
June 2005
June 2012
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