A Neo-Adjuvant Study of Sequential Epirubicin and Docetaxel in Combination With Capecitabine in Patients With Locally Advanced Breast Cancer

OBJECTIVES:

Primary

• Describe the pathologic response rate in chemotherapy-naive women with locally advanced breast cancer (stage IIIA or IIIB) after 6 courses of sequential neoadjuvant therapy with epirubicin hydrochloride and a combination of docetaxel with capecitabine .
• Describe the adverse events of sequential epirubicin hydrochloride and a combination of docetaxel with capecitabine in this patient population.

Secondary

• Identify by transcriptional profiling the differential expression of candidate gene products that confer chemosensitivity to epirubicin hydrochloride, docetaxel, and capecitabine.
• Correlate the differential expression of known genetic polymorphisms of intracellular regulators involved in the metabolism of epirubicin hydrochloride, docetaxel, and capecitabine with adverse events and tumor response.
• Assess individual patient variation in clinical (toxicity and/or activity), in pharmacologic (pharmacokinetic/pharmacodynamic parameters), and/or biologic (correlative laboratory study results) responses to epirubicin hydrochloride, docetaxel, and capecitabine due to genetic differences in proteins involved in drug response (transport, metabolism and/or mechanism of action).