Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer

Terminated

• Conditions: Breast Cancer
• Interventions: Procedure: Tumor Sample; Procedure: Serum Sample

• Registration Number: NCT01232881
• Lead Sponsor: Hoosier Cancer Research Network

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

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-01
• Study First Posted: 2010-11-02
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-27
• Last Update Posted: 2011-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tumor and Serum Collection	Serum Sample	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.
Tumor and Serum Collection	Tumor Sample	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.

Primary Outcome Measures

Name	Time	Method
To correlate tumor gene expression (genomic profile) with response to lonafarnib in patients with advanced breast cancer	24 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Indiana University Melvin and Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States