Genomic & Proteomic Analysis of Docetaxel & Capecitabine as Primary Chemo for Stage II-III Breast Cancer
Genomic and Proteomic Analysis of Docetaxel and Capecitabine as Primary Chemotherapy for Stage II-III Breast Cancer
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Mar 2003
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 15, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedJune 3, 2014
May 1, 2014
September 15, 2005
May 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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.
To compare the results of serum-based and tissue-based proteomic analyses.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana University School of Medicinelead
- Aventis Pharmaceuticalscollaborator
Study Sites (1)
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathy Miller, M.D.
Indiana University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 15, 2005
First Posted
September 20, 2005
Study Start
March 1, 2003
Study Completion
December 1, 2005
Last Updated
June 3, 2014
Record last verified: 2014-05