Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer
18 Years
N/A
Female
Breast Neoplasms
Trial Information
Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Ruth O'Regan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Winship Cancer Institute of Emory University
Authority:
United States: Institutional Review Board
Study ID:
EU822-03
NCT ID:
NCT00415285
Start Date:
December 2006
Completion Date:
Related Keywords:
- Breast Neoplasms
- Breast
- Cancer
- Early-Stage
- Chemotherapy
- Breast Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
| Grady Memorial Hospital | Atlanta, Georgia 30335 |
| Emory Crawford Long Hospital | Atlanta, Georgia 30308 |
