Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer
Both
Breast Cancer
Trial Information
Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study
OUTLINE: This is a multi-center study.
Sample Collection:
- Tumor sample
- Serum sample
Treatment Regimen:
- All registered patients must be planning treatment with lonafarnib
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
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Outcome Measure:
To correlate tumor gene expression (genomic profile) with response to lonafarnib in patients with advanced breast cancer
Outcome Time Frame:
24 months
Safety Issue:
No
Principal Investigator
George Sledge, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Hoosier Oncology Group
Authority:
United States: Institutional Review Board
Study ID:
HOG COE-03
NCT ID:
NCT01232881
Start Date:
August 2009
Completion Date:
November 2010
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
