Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer

NCT ID: NCT01232881

Last Updated: 2011-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-11-30

Brief Summary

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

Detailed Description

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OUTLINE: This is a multi-center study.

Sample Collection:

* Tumor sample
* Serum sample

Treatment Regimen:

* All registered patients must be planning treatment with lonafarnib

Conditions

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Breast Cancer

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Tumor Sample

Intervention Type PROCEDURE

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

Serum Sample

Intervention Type PROCEDURE

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

Interventions

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Tumor Sample

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

Intervention Type PROCEDURE

Serum Sample

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Indiana University School of Medicine

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role collaborator

Hoosier Cancer Research Network

OTHER

Sponsor Role lead

Responsible Party

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Hoosier Oncology Group

Principal Investigators

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George Sledge, M.D.

Role: STUDY_CHAIR

Hoosier Cancer Research Network

Locations

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Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Related Links

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http://www.hoosieroncologygroup.org

Hoosier Oncology Group Homepage

Other Identifiers

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HOG COE-03

Identifier Type: -

Identifier Source: org_study_id

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