Study Stopped
funding terminated
Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer
1 other identifier
observational
27
1 country
1
Brief Summary
This is a tumor and serum collection study for patients with advanced breast cancer receiving treatment with lonafarnib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2009
1 active site
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
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Posted
Study publicly available on registry
November 2, 2010
CompletedApril 28, 2011
April 1, 2011
1.3 years
November 1, 2010
April 27, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
To correlate tumor gene expression (genomic profile) with response to lonafarnib in patients with advanced breast cancer
24 months
Secondary Outcomes (4)
To correlate serum and tumor proteomic profiles with response to lonafarnib
24 months
To compare serum and tissue proteomic analyses
24 months
To compare genomic and proteomic profiles
24 months
To correlate toxicity and /or response with drug-specific pharmacogenomic parameters
24 months
Study Arms (1)
Tumor and Serum Collection
Tumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block. Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib.
Interventions
Tumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block.
Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib.
Eligibility Criteria
The study population will be limited to patients with advanced breast cancer receiving treatment with lonafarnib.
You may qualify if:
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age \> 18 years.
- Planned treatment with lonafarnib for metastatic breast cancer.
- Must consent to have a biopsy performed to obtain fresh tissue or be able to identify a formalin fixed paraffin embedded (FFPE) tissue block in which tumor samples can be obtained to complete the testing for this study.
You may not qualify if:
- Planned treatment with any other treatment regimen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoosier Cancer Research Networklead
- United States Department of Defensecollaborator
- Indiana University School of Medicinecollaborator
- Emory Universitycollaborator
Study Sites (1)
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Related Links
Biospecimen
Tumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block. Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
George Sledge, M.D.
Hoosier Cancer Research Network
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 1, 2010
First Posted
November 2, 2010
Study Start
August 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
April 28, 2011
Record last verified: 2011-04