Neoadjuvant Doxorubicin and Cyclophosphamide Followed by Docetaxel and S-1 in Breast Cancer
OBJECTIVES:
Primary
- Determine the rate of pathologic complete response in women with previously untreated
stage II or III breast cancer treated with neoadjuvant doxorubicin hydrochloride and
cyclophosphamide followed by docetaxel and S1.
Secondary
- Determine the safety and tolerability of this regimen in these patients.
- Determine the rate of overall radiologic response in these patients.
- Determine the rate of breast-conserving procedures in these patients.
- Determine the disease-free survival of these patients.
- Investigate the relevant pharmacogenomics and biomarker(s) which will be useful to
predict any responses to the anticancer treatments.
OUTLINE: Patients receive neoadjuvant doxorubicin hydrochloride IV and cyclophosphamide IV
on day 1. Treatment repeats every 3 weeks for up to 4 courses. Patients then receive
docetaxel IV over 1 hour on day 1 and oral S-1 on days 1-14. Treatment repeats every 3 weeks
for 4 courses. Two to four weeks later, patients undergo surgery to remove the tumor (either
breast-conserving procedures or mastectomy). Patients may then undergo radiotherapy and
receive endocrine therapy.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Rate of pathologic complete response
No
Joo Hyuk Sohn, MD, PhD
Principal Investigator
Severance Hospital
Unspecified
CDR0000650694
NCT00994968
July 2009
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