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Aromatase Inhibitor

Genetic Testing for Aromatase Inhibitor-Related Musculoskeletal Disorders

Q: For what medical conditions is anastrozole typically prescribed?

<p>Anastrozole is a common drug for treating <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a>, as well as other malignancies, hormone receptor unknowns, and tamoxifen therapy spanning 2 to 3 years.</p>

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

Study 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.Check my eligibility

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.See study design

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

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My breast cancer is positive for estrogen or progesterone receptors.

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

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I will be taking anastrozole for at least a year.

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I have finished all suggested treatments for my breast cancer.

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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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Proportion of patients whose symptoms improve when the AI is discontinued

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

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive care (anastrozole)Experimental Treatment4 Interventions

Patients receive anastrozole PO QD for 12 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anastrozole

FDA approved

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eastern Cooperative Oncology GroupLead Sponsor

268 Previous Clinical Trials

149,784 Total Patients Enrolled

31 Trials studying Breast Cancer

45,322 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,107 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Vered StearnsPrincipal InvestigatorEastern Cooperative Oncology Group

3 Previous Clinical Trials

175 Total Patients Enrolled

1 Trials studying Breast Cancer

54 Patients Enrolled for Breast Cancer

Media Library

Anastrozole (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01824836 — N/A

Breast Cancer Research Study Groups: Supportive care (anastrozole)

Breast Cancer Clinical Trial 2023: Anastrozole Highlights & Side Effects. Trial Name: NCT01824836 — N/A

Anastrozole (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01824836 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has anastrozole been investigated in previous research?

"Presently, anastrozole is being examined in 73 different trials with 25 of them at the Phase 3 stage. Though Pisa, PI houses most of these tests, other 7812 locations are also conducting experiments on this drug."

Answered by AI

Is enrollment for this experiment still available to participants?

"As evidenced on clinicaltrials.gov, this medical trial is not currently recruiting patients. Initially posted in May 2013 and last updated near the end of 2022, it has yet to be reactivated - but there are 2363 other trials actively searching for participants presently."

Answered by AI

For what medical conditions is anastrozole typically prescribed?

"Anastrozole is a common drug for treating breast cancer, as well as other malignancies, hormone receptor unknowns, and tamoxifen therapy spanning 2 to 3 years."

Answered by AI

What is the aggregate participation rate for this experiment?

"Unfortunately, this experiment has already closed its recruitment window. The original posting for the trial was on May 8th 2013 and it was most recently edited on September 9th 2022. However there are still 2290 medical trials actively recruiting patients with musculoskeletal problems as well as 73 studies looking for participants to test anastrozole treatment options."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)

2013. "A Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01824836.

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