Pharmacogenetics of Aromatase Inhibitors
Sponsor study identifier
Secondary identifiers
OTHER · Mayo Clinic Cancer Center
OTHER · Mayo Clinic IRB
observational
1,000
1 country
4
Study Start
July 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2010
Actual (reported)Study Completion
March 2010
Actual (reported)RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving anastrozole may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about how anastrozole works in the body. PURPOSE: This research study is looking at the pharmacogenetics of anastrozole in postmenopausal women with estrogen receptor-positive (ER+) and/or progesterone receptor-positive (PR+) stage I, stage II, or stage III breast cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2005
Date type not reportedThis date has not been verified as actual or estimated.
January 27, 2006
Actual (reported)January 30, 2006
Actual (reported)March 2010
Actual (reported)March 2010
Actual (reported)Association of single nucleotide polymorphisms with specific quantitative traits (i.e., hormone levels, breast density, and bone mineral density)
4 years
Association of haplotype with traits
4 years
Association of genomic pathways with traits
4 years
Blood draws for baseline and six to twelve weeks.
Blood draws for baseline and six to twelve weeks
Evaluating SNP association with traits.
analysis of plasma concentrations of drugs
Diagnosis of breast cancer. Stage I, II, or III disease. Planning to undergo treatment with anastrozole at the clinically approved dose of 1 mg/day OR Mayo Clinic Cancer Center Rochester patient who will be enrolled on or has been enrolled on CAN-NCIC-MA27 and has not started taking the study medication (anastrozole or exemestane)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259-5499, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009, United States
Ingle JN, Buzdar AU, Schaid DJ, Goetz MP, Batzler A, Robson ME, Northfelt DW, Olson JE, Perez EA, Desta Z, Weintraub RA, Williard CV, Flockhart DA, Weinshilboum RM. Variation in anastrozole metabolism and pharmacodynamics in women with early breast cancer. Cancer Res. 2010 Apr 15;70(8):3278-86. doi: 10.1158/0008-5472.CAN-09-3024. Epub 2010 Mar 30.
Liu M, Goss PE, Ingle JN, Kubo M, Furukawa Y, Batzler A, Jenkins GD, Carlson EE, Nakamura Y, Schaid DJ, Chapman JA, Shepherd LE, Ellis MJ, Khosla S, Wang L, Weinshilboum RM. Aromatase inhibitor-associated bone fractures: a case-cohort GWAS and functional genomics. Mol Endocrinol. 2014 Oct;28(10):1740-51. doi: 10.1210/me.2014-1147. Epub 2014 Aug 22.
Anastrozole treatment group samples will be used as described for this study, and then will be destroyed. Exemestane treatment group samples of blood will be stored at Mayo Clinic Rochester.
James N. Ingle, MD
Mayo Clinic
Edith A. Perez, MD
Mayo Clinic
Donald W. Northfelt, MD, FACP
Mayo Clinic
First Submitted
January 27, 2006
First Posted
January 30, 2006
Study Start
July 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2010
Actual (reported)determine bone mineral density (BMD)
determine attitude changes
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Liu M, Ingle JN, Fridley BL, Buzdar AU, Robson ME, Kubo M, Wang L, Batzler A, Jenkins GD, Pietrzak TL, Carlson EE, Goetz MP, Northfelt DW, Perez EA, Williard CV, Schaid DJ, Nakamura Y, Weinshilboum RM. TSPYL5 SNPs: association with plasma estradiol concentrations and aromatase expression. Mol Endocrinol. 2013 Apr;27(4):657-70. doi: 10.1210/me.2012-1397. Epub 2013 Mar 21.
Study Completion
March 2010
Actual (reported)Last Updated
May 16, 2011
Record last verified: 2011-05
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Source: ClinicalTrials.gov.
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