Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01232881

Enrollment

Registered

2010-11-02

Start date

2009-08-31

Completion date

2010-11-30

Last updated

2011-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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

Interventions

PROCEDURETumor Sample

Tumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block.

PROCEDURESerum Sample

Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib.

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026