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Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer

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ClinicalTrials.gov Identifier: NCT01232881
Recruitment Status : Terminated (funding terminated)
First Posted : November 2, 2010
Last Update Posted : April 28, 2011
Sponsor:
Collaborators:
United States Department of Defense
Indiana University School of Medicine
Emory University
Information provided by:
Hoosier Cancer Research Network

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

Condition or disease Intervention/treatment
Breast Cancer Procedure: Tumor Sample Procedure: Serum Sample

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
Actual Enrollment : 27 participants
Time Perspective: Prospective
Official Title: Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study
Study Start Date : August 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. To correlate tumor gene expression (genomic profile) with response to lonafarnib in patients with advanced breast cancer [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. To correlate serum and tumor proteomic profiles with response to lonafarnib [ Time Frame: 24 months ]
  2. To compare serum and tissue proteomic analyses [ Time Frame: 24 months ]
  3. To compare genomic and proteomic profiles [ Time Frame: 24 months ]
  4. To correlate toxicity and /or response with drug-specific pharmacogenomic parameters [ Time Frame: 24 months ]

Biospecimen Retention:   Samples Without DNA

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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will be limited to patients with advanced breast cancer receiving treatment with lonafarnib.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232881


Locations
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Hoosier Cancer Research Network
United States Department of Defense
Indiana University School of Medicine
Emory University
Investigators
Study Chair: George Sledge, M.D. Hoosier Cancer Research Network

Additional Information:
Responsible Party: George Sledge, M.D., Hoosier Oncology Group
ClinicalTrials.gov Identifier: NCT01232881     History of Changes
Other Study ID Numbers: HOG COE-03
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: April 28, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lonafarnib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action