Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer

Hoosier Cancer Research Network

Status: Terminated

Conditions: Breast Cancer

Treatments: Procedure: Serum Sample; Procedure: Tumor Sample

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01232881

HOG COE-03

Details and patient eligibility

About

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

Full 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

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

27 participants in 1 patient group

Tumor and Serum Collection

Description:

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.

Treatment:

Procedure: Serum Sample

Procedure: Tumor Sample