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Sponsors and Collaborators: |
UNC Lineberger Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00764322 |
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about differences in DNA and predict how well patients will respond to treatment and plan better treatment.
PURPOSE: This clinical trial is studying blood samples from women with breast cancer or ductal carcinoma in situ who are receiving tamoxifen.
Condition | Intervention |
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Breast Cancer Cancer-Related Problem/Condition |
Drug: tamoxifen citrate Procedure: gene expression analysis Procedure: pharmacogenomic studies Procedure: quality-of-life assessment Procedure: questionnaire administration |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Evaluating the Role of Genotype in Tamoxifen Therapy for Breast Cancer |
Estimated Enrollment: | 100 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Blood samples are collected at baseline to determine CYP2D6 genotype and tamoxifen citrate metabolic status (i.e., poor-metabolizing [PM], intermediate-metabolizing [IM], or extensive-metabolizing [EM] alleles). Samples are also analyzed for plasma levels of endoxifen and N-desmethyltamoxifen and for endoxifen/N-desmethyltamoxifen ratio. Patients found to be IM or PM are notified to increased tamoxifen citrate to 40 mg/day for 4 months (in the absence of unacceptable toxicity) with repeat endoxifen and N-desmethyltamoxifen levels (and the ratio) at the end of this time.
All patients complete Quality Of Life (QOL) and Menopausal Symptoms Scale (MSS) questionnaires at baseline and after 4 months of treatment. Toxicities are assessed at the end of 4 months. Patients undergo repeat questionnaire assessment of their understanding of the use of pharmacogenomics in clinical decision-making. Some patients also undergo a 30-minute, baseline interview regarding attitudes and experience towards participation in a pharmacogenomics study.
Patients who choose to be informed of the results of their genotyping are contacted by letter, along with their physicians, and offered genetic counseling to discuss the significance of these results.
After completion of study therapy, patients are followed at 4-6 months, including toxicity assessment and QOL and MSS questionnaires.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Has been receiving tamoxifen citrate at a dose of 20 mg/day for at least 4 months either for the treatment of invasive or non-invasive carcinoma of the breast or for breast cancer recurrence prevention
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent medications known to inhibit CYP2D6, including any of the following:
No concurrent selective serotonin reuptake inhibitors, except the following:
Principal Investigator: | Lisa A. Carey, MD | UNC Lineberger Comprehensive Cancer Center |
Principal Investigator: | William J. Irvin, MD | UNC Lineberger Comprehensive Cancer Center |
Principal Investigator: | Carey Anders, MD | UNC Lineberger Comprehensive Cancer Center |
Principal Investigator: | Karen Weck | UNC Lineberger Comprehensive Cancer Center |
Study ID Numbers: | CDR0000597244, UNC-LCCC-0801, LCCC0801 |
Study First Received: | October 1, 2008 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00764322 |
Health Authority: | Unspecified |
menopausal symptoms recurrent breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer |
stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer ductal breast carcinoma in situ breast cancer in situ |
Skin Diseases Citric Acid Breast Neoplasms Tamoxifen Recurrence Carcinoma Carcinoma, Ductal |
Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Adenocarcinoma Breast Diseases Menopause Neoplasms, Glandular and Epithelial |
Estrogen Antagonists Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Ductal, Lobular, and Medullary |