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A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms

NCT02874222 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2024-06-06

No results posted yet for this study

Summary

Breast cancer is one of the most prevalent cancers with 207,090 new cases of breast cancer and 39,840 deaths in women predicted for 2010 in the United States. Aromatase inhibitors (AIs) are used as first-line adjuvant therapy for postmenopausal women with early stage breast cancer. The effectiveness of current therapy is widely recognized to be compromised by poor compliance because of aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), a syndrome that affects up to 40-50% of women who take these medications. The syndrome that was not recognized during the registration trials for this class of drugs, it can lead to discontinuation in up to 24% of women over 2 years. Knowledge that can be used to prevent discontinuation of these important agents because of severe AIMSS is urgently needed.

Conditions

Interventions

OTHER

surveys completed by subject

Cohort study designed to validate previously identified associations between 10 specific SNPs and discontinuation of treatment with AIs due to the development of MSS among women with breast cancer.

Sponsors & Collaborators

  • Alliance for Clinical Trials in Oncology

    collaborator OTHER

  • United States Naval Medical Center, San Diego

    lead FED

Principal Investigators

  • Preston Gable, MD · Site PI

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2023-07-31
Completion
2024-05-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02874222 on ClinicalTrials.gov