Doxorubicin Hydrochloride, Cyclophosphamide, Docetaxel, and S-1 Before Surgery in Treating Women With Stage II or Stage III Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00994968|
Recruitment Status : Unknown
Verified October 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : October 14, 2009
Last Update Posted : October 29, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: tegafur-gimeracil-oteracil potassium Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||49 participants|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Doxorubicin and Cyclophosphamide Followed by Docetaxel and S-1 in Breast Cancer|
|Study Start Date :||July 2009|
- Rate of pathologic complete response
- Safety and tolerability
- Rate of overall radiologic response
- Rate of breast-conserving procedure
- Disease-free survival
- Relevant pharmacogenomics and biomarker(s) which may be useful to predict any responses to the anticancer treatments
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|