At a glance

ClinicalIndex Comparison Record

N/ACompleted· 104 enrolled

Drug / intervention

polymorphism analysis +2 moregenetic

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01281137

NCT01281137N/ACompleted

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SOLE Estrogen Substudy (SOLE-EST) - Investigating Changes in Estrogen Levels and Grip Strength for Patients Participating in the SOLE Trial

ETOP IBCSG Partners Foundation·observational·Posted Jan 21, 2011·Updated Oct 6, 2021

In Brief

An observational study evaluating polymorphism analysis, laboratory biomarker analysis, and 1 other intervention for Breast Cancer. Completed, enrolled 104 participants across 2 sites in 2 countries.

Detailed Summary

RATIONALE: Studying samples of blood in the laboratory from patients receiving treatment for cancer may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This clinical trial is studying changes in estrogen levels and grip strength in postmenopausal women who have received 4 to 6 years of hormone therapy for breast cancer and are currently receiving letrozole on clinical trial IBCSG-35-07.

Study Details

Study Typeobservational

Allocation--

Masking--

Primary Purpose--

ConditionsBreast Cancer

CountriesAustralia, Belgium

Collaborators--

Timeline

N/ACompletedFinished

2011201220132014201520162017201820192020202120222023202420252026

Enrollment StartJan 2011

First PostedJan 2011

Primary CompletionMay 2019

TodayJul 2026

First PostedJan 21, 2011

Enrollment StartJan 1, 2011

Primary CompletionMay 15, 2019

TodayJul 2, 2026

Enrollment to primary: 8.4 yearsPosted 15.4 years ago

Interventions

polymorphism analysisgenetic

SNPs will be genotyped in whole blood samples taken at baseline.

laboratory biomarker analysisother

Biomarkers will be assessed in blood and serum samples at different time points.

quality-of-life assessmentprocedure

Quality of life will be assessed using the Breast Cancer Prevention Trial (BCPT) Symptom Scales and the IBCSG Trial 35-07 QL Form.