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Keep this study
Lead
Indiana University
With
Aventis Pharmaceuticals
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Genomic & Proteomic Analysis of Docetaxel & Capecitabine as Primary Chemo for Stage II-III Breast Cancer
