Doxorubicin Hydrochloride, Cyclophosphamide, Docetaxel, and S-1 Before Surgery in Treating Women With Stage II or Stage III Breast Cancer
Recruitment status was Recruiting
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, docetaxel, and S-1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying giving doxorubicin hydrochloride together with cyclophosphamide, docetaxel, and S-1 before surgery in treating women with stage II or stage III breast cancer.
Drug: doxorubicin hydrochloride
Drug: tegafur-gimeracil-oteracil potassium
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Neoadjuvant Doxorubicin and Cyclophosphamide Followed by Docetaxel and S-1 in Breast Cancer|
- Rate of pathologic complete response [ Designated as safety issue: No ]
- Safety and tolerability [ Designated as safety issue: Yes ]
- Rate of overall radiologic response [ Designated as safety issue: No ]
- Rate of breast-conserving procedure [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
- Relevant pharmacogenomics and biomarker(s) which may be useful to predict any responses to the anticancer treatments [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994968
|Korea, Republic of|
|Yonsei Cancer Center at Yonsei University Medical Center||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Joo Hyuk Sohn, MD, PhD 82-2-2228-8130|
|Principal Investigator:||Joo Hyuk Sohn, MD, PhD||Severance Hospital|