Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer

April 27, 2011 updated by: Hoosier Cancer Research Network

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Melvin and Bren Simon Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will be limited to patients with advanced breast cancer receiving treatment with lonafarnib.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tumor and Serum Collection

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
To correlate serum and tumor proteomic profiles with response to lonafarnib
Time Frame: 24 months
24 months
To compare serum and tissue proteomic analyses
Time Frame: 24 months
24 months
To compare genomic and proteomic profiles
Time Frame: 24 months
24 months
To correlate toxicity and /or response with drug-specific pharmacogenomic parameters
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoosier Cancer Research Network

Collaborators

United States Department of Defense
Emory University
Indiana University School of Medicine

Investigators

  • Study Chair: George Sledge, M.D., Hoosier Cancer Research Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

November 1, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (Estimate)

November 2, 2010

Study Record Updates

Last Update Posted (Estimate)

April 28, 2011

Last Update Submitted That Met QC Criteria

April 27, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOG COE-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Tumor Sample

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe