Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer

This study has been terminated.
(funding terminated)
Sponsor:
Collaborators:
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

November 1, 2010
April 27, 2011
August 2009
November 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01232881 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer
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.

OUTLINE: This is a multi-center study.

Sample Collection:

  • Tumor sample
  • Serum sample

Treatment Regimen:

  • All registered patients must be planning treatment with lonafarnib
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
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.

Probability Sample

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

Breast Cancer
  • 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.
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.

Interventions:
  • Procedure: Tumor Sample
  • Procedure: Serum Sample
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
27
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01232881
HOG COE-03
Yes
George Sledge, M.D., Hoosier Oncology Group
Hoosier Oncology Group
  • Department of Defense
  • Indiana University School of Medicine
  • Emory University
Study Chair: George Sledge, M.D. Hoosier Oncology Group
Hoosier Oncology Group
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP