Tamoxifen Resistance in Breast Cancer
RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may help doctors identify and learn more about biomarkers related to tamoxifen resistance.
PURPOSE: This laboratory study is looking at tamoxifen resistance in women with stage I, stage II, stage IIIA, or stage IIIB breast cancer.
Description
OBJECTIVES:
Identify women who are resistant to tamoxifen citrate and other drugs for the treatment of breast cancer by testing their plasma for the presence of proteins (e.g., macrophage migration inhibition factor) encoded by resistance-inducing genes (RIGs).
Provide retrospective data on the predictive value of RIGs to serve as the basis for a prospective clinical trial of these genes as predictors of drug resistance.
OUTLINE: This is a multicenter study. Patients are stratified according to response during tamoxifen citrate (TAM) therapy (resistant group [i.e., those who develop recurrent breast cancer while being treated with TAM] vs conditionally sensitive group [i.e., those who have disease-free survival for over 3 years after initial diagnosis while being treated with TAM]).
Patients undergo blood collection at baseline, within 3 weeks of initiation of TAM therapy, and then every 6 months for 3 years or until relapse, whichever comes first. Samples are analyzed by enzyme-linked immunosorbent assay for expression of protein biomarkers (i.e., kallikrein gene 10, macrophage migration inhibition factor, prolyl carboxypeptidase, queuine tRNA-ribosyltransferase, and kinesin) encoded by resistance-inducing genes. An additional blood sample is obtained from patients at the time of relapse, if available.
Patients also undergo assessment of medical history, personal habits, and characteristics of breast cancer (e.g., tumor histology, stage, and grade) at baseline.
Status: Active, not recruiting (N/A). Started on May 1st, 2007.
Enrollment: 80 subjects
Study Type: Observational
Study Design:
- Observational Model: Cohort
- Time Perspective: Prospective
Conditions:
Interventions:
- Drug: tamoxifen citrate
- Genetic: gene expression analysis
- Genetic: protein expression analysis
- Other: immunoenzyme technique
- Other: laboratory biomarker analysis
Eligibility
Inclusion Criteria:
Histologically confirmed invasive breast cancer
Initial pathologic stage I-IIIB disease
No stage IV disease
Meets the following criteria for breast cancer therapy:
Received prior primary local therapy for breast cancer
Scheduled to begin tamoxifen citrate as adjuvant therapy for breast cancer within 3 weeks
Hormone receptor status:
- Estrogen-receptor positive tumor
Female
Pre- or post-menopausal
Must be able to donate 20 mL of blood
Exclusion Criteria:
Severe anemia, defined as hemoglobin < 11 g/dL
Psychiatric history that would preclude obtaining informed consent
- Gender
Female
- Mininum Age
18 Years
- Maximum Age
N/A
- Healthy Volunteers
No
Resources
Source: Wake Forest University
Authority: United States: Institutional Review Board
Locations
-
Wake Forest University Comprehensive Cancer Center
Winston-Salem
North Carolina
27157-1096
United States
Officials
Steven A. Akman, MD (Study Chair, Wake Forest University)
Sponsors
Wake Forest University (Lead Sponsor)
National Cancer Institute (NCI) (Collaborator)
References
None.
Links
- Date Verified
- April 1st, 2010
- First Received
- April 29th, 2010
- Last Changed
- April 29th, 2010
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
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