Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine for Early Stage Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Capecitabine
* Drug: Docetaxel/Capecitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Docetaxel|nan|
|Drug: Capecitabine|nan|
|Drug: Docetaxel/Capecitabine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast, Cancer, Early-Stage, Chemotherapy