Genomic & Proteomic Analysis of Docetaxel & Capecitabine as Primary Chemo for Stage II-III Breast Cancer

Study Overview
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Brief Summary
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The primary objective of this study is to determine the efficacy & toxicity of combined docetaxel & capecitabine as primary chemo for subjects w/ stage II-III breast cancer.

Detailed Description
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The primary objective of this study is to determine the efficacy & toxicity of combined docetaxel & capecitabine as primary chemotherapy for subjects with stage II-III breast cancer.Subjects will be randomized into one of two groups: Docetaxel followed by four cycles of docetaxel & capecitabine vs. capecitabine followed by four cycles of docetaxel and capecitabine.

Official Title
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Genomic and Proteomic Analysis of Docetaxel and Capecitabine as Primary Chemotherapy for Stage II-III Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: docetaxel & capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed adenocarcinoma of the breast w/ Stage II-III disease w/ a primary tumor >/=2cm or clinically palpable axillary lymph nodes. Pre-treatment core or incisional bx w/ adequate tissue for histology & genomic/proteomic analysis. Primary tumor must be bi-dimensionally measurable by physical exam or dx breast imaging. Measurements must be obtained w/in 3 wks prior to study entry. Adequate organ fxn:AGC>1500; Hb>/=9.0;plts>/=100K; Crt</=2.0;Cacl Crt Clr>/=50; total bili</=ULN; LFTs<2.0 ULN ECOG performance status 0-1 Neg. pregnancy test Exclusion Criteria: Pts may not have had definitive primary surgery. Metastatic breast cancer Any prior chemo or hormonal therapy for breast cancer Prior history of malignancy w/in the previous 5 yrs. No active unresolved infection No major surgery w/in 2wks of start of study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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 & capecitabine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to determine the efficacy & toxicity of combined docetaxel & capecitabine as primary chemotherapy for subjects with stage II-III breast cancer. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate genomic and proteonomic changes after initial therapy with docetaxel & capecitabine as monotherapy after combined docetaxel & capecitabine therapy. |  |  | 
| To compare pre-treatment genomic and proteomic profiles in responders and non-responders. |  |  | 
| To compare the results of serum-based and tissue-based proteomic analyses. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer