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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
Not Enrolling
Both
Breast Cancer

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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 CenterIndianapolis, Indiana  46202-5289