Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01232881
• Other study ID #: HOG COE-03
• Status: Terminated
• Phase: N/A
• First received: November 1, 2010
• Last updated: April 27, 2011
• Start date: August 2009
• Est. completion date: November 2010

Study information

• Verified date: April 2011
• Source: Hoosier Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Tumor Sample
Tumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block.
• Serum Sample
Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib.

Locations

Country	Name	City	State
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana

Sponsors (4)

Lead Sponsor	Collaborator
Hoosier Cancer Research Network	Emory University, Indiana University School of Medicine, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To correlate tumor gene expression (genomic profile) with response to lonafarnib in patients with advanced breast cancer		24 months	No
Secondary	To correlate serum and tumor proteomic profiles with response to lonafarnib		24 months	No
Secondary	To compare serum and tissue proteomic analyses		24 months	No
Secondary	To compare genomic and proteomic profiles		24 months	No
Secondary	To correlate toxicity and /or response with drug-specific pharmacogenomic parameters		24 months	Yes

External Links

•   Hoosier Oncology Group Homepage