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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00198237

Run by

Indiana University

People needed

40

Starts

2003-03-01

Expected to finish

2005-12-01

Last updated by the study team

2014-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Indiana University Cancer Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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