Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study

Hoosier Cancer Research Network1 site in 1 country27 target enrollmentAugust 2009

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Hoosier Cancer Research Network
Enrollment: 27
Locations: 1
Primary Endpoint: To correlate tumor gene expression (genomic profile) with response to lonafarnib in patients with advanced breast cancer
Status: Terminated
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a tumor and serum collection study for patients with advanced breast cancer receiving treatment with lonafarnib.

Detailed Description

OUTLINE: This is a multi-center study. Sample Collection: * Tumor sample * Serum sample Treatment Regimen: * All registered patients must be planning treatment with lonafarnib

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

November 2010

Last Updated

15 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoosier Cancer Research Network

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•Planned treatment with any other treatment regimen

Outcomes

Primary Outcomes

To correlate tumor gene expression (genomic profile) with response to lonafarnib in patients with advanced breast cancer

Time Frame: 24 months

Secondary Outcomes

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)