Status:
COMPLETED
Genomic & Proteomic Analysis of Docetaxel & Capecitabine as Primary Chemo for Stage II-III Breast Cancer
Lead Sponsor:
Indiana University School of Medicine
Collaborating Sponsors:
Aventis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00198237
Start Date
March 1 2003
End Date
December 1 2005
Last Update
June 3 2014
Active Locations (1)
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1
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202