Studying Blood Samples From Women With Breast Cancer or Ductal Carcinoma In Situ Who Are Receiving Tamoxifen
NCT ID: NCT00764322
Last Updated: 2017-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
501 participants
INTERVENTIONAL
2008-06-18
2011-07-01
Brief Summary
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PURPOSE: This clinical trial is studying blood samples from women with breast cancer or ductal carcinoma in situ who are receiving tamoxifen.
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Detailed Description
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Primary
* To evaluate the change in endoxifen levels after an increase in tamoxifen citrate dose from 20 mg to 40 mg in women with breast cancer or ductal breast carcinoma in situ with intermediate-metabolizing CYP2D6 genotypes.
Secondary
* To evaluate the tolerability of increasing the dose of tamoxifen citrate from 20 to 40 mg per day in these patients.
* To assess the feasibility of obtaining pharmacogenomic information from patients in the clinical setting and using it to guide changes in therapy.
* To examine CYP2D6 allele frequencies and endoxifen levels among African-American women taking tamoxifen citrate.
* To evaluate the change in plasma endoxifen levels after an increase in the tamoxifen citrate dose from 20 mg to 40 mg daily in patients with poor-metabolizing genotypes.
* To study patient understanding of pharmacogenomics and obstacles to participation in clinical trials based upon germline DNA.
OUTLINE: This is a multicenter study.
Blood samples are collected at baseline to determine CYP2D6 genotype and tamoxifen citrate metabolic status: 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 3-6 months, including toxicity assessment and QOL and MSS questionnaires.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tamoxifen 20
One arm, containing the ultra-rapid and extensive metabolizer genotypes, continues treatment with tamoxifen at 20mg.
tamoxifen citrate
Women found to be IM or PM will undergo increased tamoxifen to 40 mg/day (20 mg bid). Drug is given orally on a daily basis.
gene expression analysis
Genetic analysis of blood sample.
pharmacogenomic studies
Genetic analysis of blood sample.
questionnaire administration
Questionnaire called the survey of participants. Questionnaires is self administered on paper documents and given pre-study, and at 4 months
quality-of-life assessment
Self administration of a multiquestion questionnaire called the Functional Assessment of Cancer Therapy -Breast (FACT-B). Given pre-study, at 4 months and at 8-10 months.
Tamoxifen 40
This arm, containing the intermediate and poor metabolizer genotypes, receives escalated treatment with tamoxifen at 40mg.
tamoxifen citrate
Women found to be IM or PM will undergo increased tamoxifen to 40 mg/day (20 mg bid). Drug is given orally on a daily basis.
gene expression analysis
Genetic analysis of blood sample.
pharmacogenomic studies
Genetic analysis of blood sample.
questionnaire administration
Questionnaire called the survey of participants. Questionnaires is self administered on paper documents and given pre-study, and at 4 months
quality-of-life assessment
Self administration of a multiquestion questionnaire called the Functional Assessment of Cancer Therapy -Breast (FACT-B). Given pre-study, at 4 months and at 8-10 months.
Interventions
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tamoxifen citrate
Women found to be IM or PM will undergo increased tamoxifen to 40 mg/day (20 mg bid). Drug is given orally on a daily basis.
gene expression analysis
Genetic analysis of blood sample.
pharmacogenomic studies
Genetic analysis of blood sample.
questionnaire administration
Questionnaire called the survey of participants. Questionnaires is self administered on paper documents and given pre-study, and at 4 months
quality-of-life assessment
Self administration of a multiquestion questionnaire called the Functional Assessment of Cancer Therapy -Breast (FACT-B). Given pre-study, at 4 months and at 8-10 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Expected duration of tamoxifen citrate treatment at least 6 months Hormone receptor status not specified Concurrent participation in non-treatment studies allowed provided it will not interfere with participation in this study Menopausal status not specified Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy ≥ 6 months Absolute Neutrophil Count (ANC) ≥ 1.0 x 10\^9/L Platelet count ≥ 100 x 10\^9/L Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 times Upper Limit of Normal (ULN) Total bilirubin ≤ 2.5 times ULN Creatinine clearance ≥ 50 mL/min Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* No limitations to number of prior therapies
* No limitations for prior radiotherapy
* More than 14 days since prior and no other concurrent investigational agent
Exclusion:
Not pregnant or nursing No active, serious infection or medical or psychiatric illness likely to preclude study participation No psychiatric conditions that would preclude study compliance or informed consent No history of venous thromboembolism, transient ischemic attack, or cerebral vascular accident No history of allergic reaction to tamoxifen citrate or any of its reagents No concurrent coumadin
No concurrent medications known to inhibit CYP2D6, including any of the following:
* Amiodarone
* Haloperidol
* Indinavir
* Ritonavir
* Quinidine
No concurrent selective serotonin reuptake inhibitors, except the following:
* Venlafaxine
* Citalopram
21 Years
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Lisa A. Carey, MD
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
William J. Irvin, MD
Role: PRINCIPAL_INVESTIGATOR
Bon Secours Virginia Health System / Bon Secours Cancer Institute
Locations
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Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, United States
Rex Cancer Center at Rex Hospital
Raleigh, North Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Countries
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Related Links
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Clinical trial summary from the National Cancer Institute's PDQ® database
Other Identifiers
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08-0483
Identifier Type: OTHER
Identifier Source: secondary_id
LCCC 0801
Identifier Type: -
Identifier Source: org_study_id
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