Doxorubicin Hydrochloride, Cyclophosphamide, Docetaxel, and S-1 Before Surgery in Treating Women With Stage II or Stage III Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00994968
- Lead Sponsor
- Yonsei University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 49
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of pathologic complete response
- Secondary Outcome Measures
Name Time Method Rate of breast-conserving procedure Safety and tolerability Rate of overall radiologic response Disease-free survival Relevant pharmacogenomics and biomarker(s) which may be useful to predict any responses to the anticancer treatments
Trial Locations
- Locations (1)
Yonsei Cancer Center at Yonsei University Medical Center
🇰🇷Seoul, Korea, Republic of