Breast Cancer Clinical Trial
Genomic & Proteomic Analysis of Docetaxel & Capecitabine as Primary Chemo for Stage II-III Breast Cancer
Summary
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.
Full Description
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.
Eligibility Criteria
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/=50; total bili 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
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There is 1 Location for this study
Indianapolis Indiana, 46202, United States
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