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

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00198237
• Lead Sponsor: Indiana University School of Medicine

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 randomized into one of two groups: Docetaxel followed by four cycles of docetaxel \& capecitabine vs. capecitabine followed by four cycles of docetaxel and capecitabine.

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-20
• Study Completion: 2005-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-30
• Last Update Posted: 2014-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To compare the results of serum-based and tissue-based proteomic analyses.
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.

Trial Locations

Locations (1)

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States