Study Stopped
Funding terminated
A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer
Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01
2 other identifiers
observational
80
2 countries
11
Brief Summary
The proposed trial provides a unique opportunity in that it combines genomic, proteomic, and pharmacogenomic assessments in patients receiving the most commonly used chemotherapies for advanced breast cancer. To date no other trial has analyzed gene and protein expression at the same time points in the same patient, combined with clinical outcome. Similar to previous attempts to predict response based on expression of a single gene or protein, the researchers expect that neither genomic or proteomic profiling alone will be sufficient to optimize therapy. Rather, the researchers expect an iterative process that combines information gleaned from both platforms, modified to avoid toxicity based on pharmacogenomics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2005
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 6, 2005
CompletedFirst Posted
Study publicly available on registry
October 10, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedDecember 9, 2015
December 1, 2015
5.3 years
October 6, 2005
December 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
To correlate tumor gene expression (genomic profile) with response to commonly used chemotherapies in patients with advanced breast cancer
36 months
Secondary Outcomes (4)
To correlate serum and tumor proteomic profiles with response to commonly used chemotherapies.
36 months
To compare serum and tissue proteomic analyses.
36 months
To compare genomic and proteomic profiles.
36 months
To correlate toxicity and/or response with drug-specific pharmacogenomic parameters.
36 months
Study Arms (4)
A
Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 2 of every 21-day cycle
B
Capecitabine 1000mg/m2 bid days 1-14 of every 21-day cycle
C
Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
D
Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle
Interventions
Eligibility Criteria
Study limited to patients with breast cancer.
You may qualify if:
- Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease.
- Disease amenable to pre-treatment core or incisional biopsy with adequate tissue for histology and genomic/proteomic analysis.
- Measurable disease as assessed within 21 days prior to being registered for protocol therapy by RECIST.
- Planned chemotherapy with one of the following regimens:
- Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
- Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle
- Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
- Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle
You may not qualify if:
- No serious uncontrolled medical or surgical condition that the investigator feels might compromise study participation.
- Negative pregnancy test obtained within 7 days prior to being registered for protocol therapy for women of child bearing potential.
- Unwillingness to use adequate contraception (or practicing complete abstinence). Subjects should be advised that adequate contraception (or complete abstinence) must be continued while on treatment and for a period of 3 months after the final dose of chemotherapy.
- No breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoosier Cancer Research Networklead
- United States Department of Defensecollaborator
- Indiana University School of Medicinecollaborator
- Walther Cancer Institutecollaborator
Study Sites (11)
Cancer Care Center of Southern Indiana
Bloomington, Indiana, 47403, United States
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815, United States
Center for Cancer Care at Goshen Health System
Goshen, Indiana, 46527, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
Mary Lou Mayer, M.D.
Indianapolis, Indiana, 46227, United States
Community Regional Cancer Center
Indianapolis, Indiana, 46256, United States
Arnett Cancer Care
Lafayette, Indiana, 47904, United States
Horizon Oncology Center
Lafayette, Indiana, 47905, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601, United States
Baylor College of Medicine - Methodist Breast Center
Houston, Texas, 77030, United States
Instituto de Enfermedades Neoplasticas (INEN)
Lima, Peru
Related Links
Biospecimen
core biopsy, serum, urine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kathy Miller, M.D.
Hoosier Oncology Group, LLC
- PRINCIPAL INVESTIGATOR
George Sledge, M.D.
Hoosier Oncology Group, LLC
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, IU School of Medicine
Study Record Dates
First Submitted
October 6, 2005
First Posted
October 10, 2005
Study Start
September 1, 2005
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
December 9, 2015
Record last verified: 2015-12