Prospective Study of UDP-gluconoryltransferase (UGT) 2B17 Genotype as a Predictive Marker of Exemestane Pharmacokinetics and Pharmacodynamics in Asian Women With Hormone Receptor-positive Advanced Breast Cancer
This is a prospective non-randomised open-label study of exemestane in post-menopausal,
hormone receptor positive advanced breast cancer patients, with pre-specified analysis of
exemestane pharmacokinetics and pharmacodynamics according to UGT2B17 genotype (UGT2B17*2/*2
versus those with at least one wild-type allele). A total of 110 patients will be enrolled
over a period of 30 months. Eligible patients will receive exemestane 25mg daily orally (as
part of standard care) until progression of disease or intolerable toxicities. At the time
of study entry, blood samples will be drawn for genotyping studies (for research purposes)
but investigators will be blinded to the results. Pharmacokinetic sampling for exemestane
and its metabolites will be performed at baseline and on day 29 (+/- 3 days) before dosing
and 0.5, 1, 2, 4, 6, 8 and 24 hours after exemestane ingestion. Patients will be evaluated
on an 8-weekly basis for toxicities and efficacy assessments during the first 6 months of
treatment, followed by 12-weekly thereafter until disease progression, unacceptable
toxicities, or patient withdrawal.
Interventional
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Correlation of UGT2B17*2 deletion genotype with clinical benefit rate (CBR)
The correlation of genotype (UGT2B17 *2/*2 versus those with at least one wild-type allele) with clinical benefit rate (CBR), defined as the percentage achieving CR, PR and SD in patients with measurable disease or the absence of disease progression in patients with non-measurable disease, lasting at least 24 weeks.
24 weeks
No
Andrea LA Wong, MBBS
Principal Investigator
National University Hospital, Singapore
Singapore: Domain Specific Review Boards
BR05/14/12
NCT01655004
August 2012
August 2016
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