NCT00228956

A Multi-Center Randomized Clinical Trial Correlating the Effects of 24 Months of Exemestane or Letrozole on Surrogate Markers of Response With Aromatase Polymorphism

Status unknown Last updated 24 September 2008

What this trial tests

trial testing pharmacodynamic analysis in Breast Cancer in 500 participants. Status unknown.

Timeline

1 January 2005

1 February 2009

Quick facts

Lead sponsor	National Institute of General Medical Sciences (NIGMS)
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	500
Start date	1 January 2005
Estimated completion	1 February 2009
Sites	3 locations across United States

Drugs / interventions tested

• pharmacodynamic analysis — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

National Institute of General Medical Sciences (NIGMS)

Who can join

Adults 40 to 70, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

You are invited to participate in a research study looking at metabolism (breakdown) and effects of aromatase inhibitors. The purpose of this research is to try to identify which women who take an aromatase inhibitor are more likely to have certain benefits or side effects from the drug. We will do so by determining whether there are differences that normally occur in genes that you have inherited from your parents that might influence the way individuals respond to medications. If you agree to participate in this study, you will be asked to sign this informed consent form.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Predictors of aromatase inhibitor discontinuation as a result of treatment-emergent symptoms in early-stage breast cancer.
   Henry NL, Azzouz F, Desta Z, Li L, et al · · 2012 · cited 292× · PMID 22331951 · DOI 10.1200/jco.2011.38.0261
2. Plasma letrozole concentrations in postmenopausal women with breast cancer are associated with CYP2A6 genetic variants, body mass index, and age.
   Desta Z, Kreutz Y, Nguyen AT, Li L, et al · · 2011 · cited 80× · PMID 21975350 · DOI 10.1038/clpt.2011.174
3. Patient-reported symptoms and discontinuation of adjuvant aromatase inhibitor therapy.
   Kidwell KM, Harte SE, Hayes DF, Storniolo AM, et al · · 2014 · cited 77× · PMID 24802413 · DOI 10.1002/cncr.28756
4. Patient-Reported Outcomes and Early Discontinuation in Aromatase Inhibitor-Treated Postmenopausal Women With Early Stage Breast Cancer.
   Kadakia KC, Snyder CF, Kidwell KM, Seewald NJ, et al · · 2016 · cited 62× · PMID 27009936 · DOI 10.1634/theoncologist.2015-0349
5. Comparison of breast cancer recurrence risk and cardiovascular disease incidence risk among postmenopausal women with breast cancer.
   Bardia A, Arieas ET, Zhang Z, Defilippis A, et al · · 2012 · cited 60× · PMID 22042368 · DOI 10.1007/s10549-011-1843-1
6. Genetic associations with toxicity-related discontinuation of aromatase inhibitor therapy for breast cancer.
   Henry NL, Skaar TC, Dantzer J, Li L, et al · · 2013 · cited 53× · PMID 23546553 · DOI 10.1007/s10549-013-2504-3
7. Inflammatory cytokines and aromatase inhibitor-associated musculoskeletal syndrome: a case-control study.
   Henry NL, Pchejetski D, A'Hern R, Nguyen AT, et al · · 2010 · cited 36× · PMID 20606683 · DOI 10.1038/sj.bjc.6605768
8. A prospective study of aromatase inhibitor-associated musculoskeletal symptoms and abnormalities on serial high-resolution wrist ultrasonography.
   Henry NL, Jacobson JA, Banerjee M, Hayden J, et al · · 2010 · cited 34× · PMID 20549827 · DOI 10.1002/cncr.25385