Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine for Early Stage Breast Cancer
Conditions
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Breast, Cancer, Early-Stage, Chemotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Docetaxel Type: Drug
Name: Capecitabine Type: Drug
Name: Docetaxel/Capecitabine Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.
Detailed Description
The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

Induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo. Previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome. Additionally, we will correlate specific molecular markers in the breast tumors before and after chemotherapy, with response to treatment.

Expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively.

Approximately 100 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital and Grady Health System in Atlanta, Georgia.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Histologically or cytologically confirmed breast carcinoma.

- Early stage breast cancer (stage 1, 2, 3).

- No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.

- 18 years of age or older.

- Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Exclusion Criteria:

- Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.

- Major surgery within 28 days of study entry.

- Evidence of CNS metastases.

- Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Locations
Emory Crawford Long Hospital
Atlanta, Georgia, United States
Status: Recruiting
Contact: Rita Johnson - 404-778-7777
Grady Memorial Hospital
Atlanta, Georgia, United States
Status: Recruiting
Contact: Rita Johnson - 404-778-7777
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Status: Recruiting
Contact: Rita Johnson - 404-778-7777
Start Date
December 2006
Sponsors
Georgia Center for Oncology Research & Education
Source
Georgia Center for Oncology Research & Education
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page