NCT00815555

Brief Summary

The aim of the study is to examine whether tamoxifen-treated Israeli breast cancer patients who are CYP2D6 poor metabolizers (CYP2D6\*4/\*4 genotype) are at higher cancer relapse risk during 2.5-5-year follow-up period from initial diagnosis and primary treatment.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

December 30, 2008

Status Verified

December 1, 2008

Enrollment Period

3 years

First QC Date

December 28, 2008

Last Update Submit

December 29, 2008

Conditions

Breast Cancer

Keywords

receptor positive breast cancerTamoxifen treatmentCYP2D6 statusrelapse

Outcome Measures

Primary Outcomes (1)

  • Tamoxifen efficacy for avoiding breast cancer relapse in relation to CYP2D6 genotype

Secondary Outcomes (1)

  • Prevalence of CYP2D6 poor metabolizers genotype in Israeli female population treated with Tamoxifen

Study Arms (1)

1

Women diagnosed with receptor positive breast cancer, treated with Tamoxifen

Other: There is no intervention - this is an observational study

Interventions

There is no intervention - this is an observational studyOTHER
1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women diagnosed with receptor positive breast cancer, treated with Tamoxifen

You may qualify if:

  • Female
  • Age \> 18
  • Treated with Tamoxifen following diagnosis of breast cancer

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Pharmacology Unit - Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Breast NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Matitiahu Berkovitch, Prof

CONTACT

972-57-345152mberkovitch@asaf.health.gov.il

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 28, 2008

First Posted

December 30, 2008

Study Start

December 1, 2008

Primary Completion

December 1, 2011

Last Updated

December 30, 2008

Record last verified: 2008-12

Locations

IL(1)