CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 115 enrolled
Drug / intervention
anastrozole, letrozole, exemestane +1 moredrug
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/NCT01896050
NCT01896050N/ACompleted

A Prospective Assessment of Loss of Grip Strength by Baseline BMI in Breast Cancer Patients Receiving Adjuvant Third-generation Aromatase Inhibitors and Tamoxifen

University of Michigan Rogel Cancer Center·observational·Posted Jul 11, 2013·Updated Jun 28, 2016

In Brief

An observational study evaluating anastrozole, letrozole, exemestane and Tamoxifen for Breast Cancer and 2 related conditions. Completed, enrolled 115 participants across 1 site.

Detailed Summary

Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease. Typical agents used for treatment include tamoxifen and the aromatase inhibitors. In postmenopausal women, aromatase inhibitor therapy is increasingly common because it is associated with fewer long-term serious toxicities compared to tamoxifen. However, aromatase inhibitors cause arthralgias in 40-50% of patients, which can influence adherence to therapy and can lead to treatment discontinuation in a minority of cases. The mechanism underlying development of this toxicity remains unclear, and predictors of who will develop these symptoms remain undefined. Initial reports suggest that grip strength decreases during aromatase inhibitor therapy, and that body-mass index may influence development of this symptom. Therefore, this longitudinal study has been developed to determine change in grip strength over time in women treated with aromatase inhibitors and tamoxifen, as well as to identify potential associations between change in grip strength and BMI. Patient self-reported symptoms will also be collected. A total of 115 women with early stage breast cancer who are initiating therapy with either an aromatase inhibitor or tamoxifen will be enrolled.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 11, 2013
Enrollment StartSep 1, 2009
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 13.0 years ago

Interventions

anastrozole, letrozole, exemestanedrug

Patients were treated with one of the listed anti-hormonal medications for up to one year

Tamoxifendrug

Patients were treated with tamoxifen for up to one year