Genetic Testing for Aromatase Inhibitor-Related Musculoskeletal Disorders

N/A

Waitlist Available

Led By Vered Stearns

Research Sponsored by Eastern Cooperative Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have estrogen and/or progesterone receptor positive histologically confirmed stage I-III adenocarcinoma of the breast

Eastern Cooperative Oncology Group (ECOG) performance status between 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing whether genetic information can help predict which patients will develop muscle and skeleton-related side effects from aromatase inhibitors, so that doctors can better tailor treatments.

Who is the study for?

This trial is for post-menopausal women with stage I-III breast cancer that's estrogen/progesterone receptor positive. They should be planning to take anastrozole for at least a year, have pain rated less than 4 out of 10, and not have had certain prior treatments or chronic conditions needing daily pain medication.

What is being tested?

The study aims to find genetic markers predicting if patients will stop using aromatase inhibitors due to musculoskeletal symptoms. It involves taking anastrozole, answering questionnaires, lab biomarker analysis, and pharmacogenomic studies.

What are the potential side effects?

Anastrozole may cause joint pain/stiffness (musculoskeletal symptoms), hot flashes, weakness, sore throat, nausea and vomiting, high blood pressure, depression and osteoporosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My breast cancer is positive for estrogen or progesterone receptors.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I will be taking anastrozole for at least a year.

Select...

I have finished all suggested treatments for my breast cancer.

Select...

I have not taken exemestane, letrozole, or anastrozole for breast cancer prevention or after surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Discontinuation of treatment following development of AIMSS determined by scores on the Health Assessment Questionnaire (HAQ) instrument

Secondary study objectives

Presence of SNPs in the estrogen receptor alpha (ESR), T-cell leukemia/lymphoma 1A (TCL1A), and CYP19A1 genes

Proportion of patients with symptoms determined not to be from other known etiologies as assessed by the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) and Breast subscale

Proportions of patients with treatment discontinuation for any reason

+2 more