Genotyping and Phenotyping of CYP2D6 Breast Cancer Patien... | NCT03504631

Studies
Genotyping and Phenotyping of CYP2D6 Breast Cancer Patients on Tamoxifen

NCT03504631

Sponsor

Trisakti University

Status

Unknown status

Last Update Posted

Apr 24, 2018Actual

Enrollment

117Estimated

Phase

Not provided

Conditions

Breast Cancer Female

Interventions

No intervention

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Oct 1, 2018Estimated

Completion Date

Dec 1, 2018Estimated

First Submitted Date

Apr 12, 2018

First Submission Date that Met QC Criteria

Apr 12, 2018

First Posted Date

Apr 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2018

Last Update Posted Date

Apr 24, 2018Actual

Name	Class
Dharmais National Cancer Center Hospital	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is an observational study to determine phenotype and genotype of CYP2D6 as predictors of z-endoxifen concentrations in plasma of outgoing patients treated with tamoxifen for at least 4 months

Detailed Description

Tamoxifen is an antiestrogen drug with concentration dependent properties, with z-endoxifen known as active metabolite. Until know therapeutic range for z-endoxifen to improve treatment response was not known. Variation response on tamoxifen can be cause of genetic polymorphism CYP2D6 that can be different between interindividul and ethnic.

The aim of this study is to determine phenotype and genotype of CYP2D6 as predictors of z-endoxifen concentrations in plasma of outgoing patients treated with tamoxifen for at least 4 months

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

117Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Breast cancer patients on tamoxifen		Patients currently on treatment with tamoxifen for at least 4 months.	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	no intervention	Breast cancer patients on tamoxifen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Genotype and phenotype of CYP2D6	Number of subjects with CYP2D6 genotype and phenotype who had steady state level	4 months

Secondary Outcomes

Measure	Description	Time Frame
Z-endoxifen	Number of subjects with plasma levels of Z-endoxifen more than 5.9 ng/mL	4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Breast cancer patients on tamoxifen treatment for at least 4 months

Exclusion Criteria:

Abnormalities in liver markers (AST >2.5 x ULN)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female only

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Outpatient breast cancer patients on tamoxifen treatment for at least 4 months

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yenny, MD	Contact	+628159661333		yenfarmako@gmail.com

Overall Officials

Name	Affiliation	Role
Rianto Setiabudy, MD, PhD	Indonesia University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dharmais hospital	Recruiting	Jakarta	DKI Jakarta	11420	Indonesia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21430657	Background	Madlensky L, Natarajan L, Tchu S, Pu M, Mortimer J, Flatt SW, Nikoloff DM, Hillman G, Fontecha MR, Lawrence HJ, Parker BA, Wu AH, Pierce JP. Tamoxifen metabolite concentrations, CYP2D6 genotype, and breast cancer outcomes. Clin Pharmacol Ther. 2011 May;89(5):718-25. doi: 10.1038/clpt.2011.32. Epub 2011 Mar 23.
24390246	Background

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases