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Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer

This study has been terminated.
(funding terminated)
Sponsor:
Collaborators:
Department of Defense
Indiana University School of Medicine
Emory University
Information provided by:
Hoosier Oncology Group
ClinicalTrials.gov Identifier:
NCT01232881
First received: November 1, 2010
Last updated: April 27, 2011
Last verified: April 2011
History of Changes
  Purpose

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


Condition Intervention
Breast Cancer
 Procedure: Tumor Sample
Procedure: Serum Sample

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoosier Oncology Group:

Primary Outcome Measures:
  • To correlate tumor gene expression (genomic profile) with response to lonafarnib in patients with advanced breast cancer [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To correlate serum and tumor proteomic profiles with response to lonafarnib [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To compare serum and tissue proteomic analyses [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To compare genomic and proteomic profiles [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To correlate toxicity and /or response with drug-specific pharmacogenomic parameters [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

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.


Enrollment: 27
Study Start Date: August 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232881

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

Additional Information:
Hoosier Oncology Group Homepage  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: George Sledge, M.D., Hoosier Oncology Group
ClinicalTrials.gov Identifier: NCT01232881     History of Changes
Other Study ID Numbers: HOG COE-03
Study First Received: November 1, 2010
Last Updated: April 27, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013