Genetic Testing for Aromatase Inhibitor-Related Musculoskeletal Disorders

Not currently recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: ECOG-ACRIN Cancer Research Group

Must be taking: Aromatase inhibitors

Must not be taking: Analgesics

Disqualifiers: Prior AI therapy, DVT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether genetic information can predict which breast cancer patients might stop taking anastrozole (also known as Arimidex) due to muscle and joint pain. Anastrozole treats women with stage I-III breast cancer who have undergone menopause and have certain hormone-positive tumors. Eligible participants should have completed other cancer treatments, plan to use anastrozole for at least a year, and not suffer from severe pain or other chronic pain conditions. The study aims to tailor treatments to each patient's needs, potentially improving their experience and outcomes. As an unphased trial, it offers patients the chance to contribute to personalized treatment approaches, enhancing future care strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking daily pain medications for chronic conditions. Low dose aspirin is allowed.

What prior data suggests that genetic testing is safe for predicting musculoskeletal disorders in breast cancer patients?

Research shows that anastrozole, a common breast cancer treatment, can cause some side effects. Studies indicate that many patients taking anastrozole often experience joint pain or other muscle and bone discomfort, with 20% to 74% of women reporting these symptoms. Anastrozole can also weaken bones, increasing the risk of fractures.

These side effects can impact daily life and might lead some patients to stop the treatment. However, the treatment has been tested extensively, and its safety is well-documented. While these side effects are common, they can be managed. It's important to discuss any concerns with a healthcare provider, who can suggest ways to help manage symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using genetic testing with anastrozole for managing aromatase inhibitor-related musculoskeletal disorders. Anastrozole is already known as a common aromatase inhibitor used in breast cancer treatment, but the focus here is on understanding how genetic factors might influence side effects like joint pain and stiffness. By identifying genetic markers, doctors could potentially tailor treatments to individual patients, minimizing discomfort and improving quality of life. This personalized approach is what sets this trial apart from existing, one-size-fits-all treatment strategies.

What evidence suggests that genetic testing can predict musculoskeletal symptoms in breast cancer patients on anastrozole?

Research has shown that anastrozole, which participants in this trial will receive, effectively treats breast cancer by lowering estrogen levels, helping to slow the growth of certain breast tumors. However, it often causes muscle and joint pain, leading some patients to stop treatment. Studies have found that about 8% of women taking aromatase inhibitors, like anastrozole, experience general pain, and 6% report bone pain. Additionally, research indicates a significant decrease in bone strength in patients using anastrozole over time. Despite these side effects, anastrozole remains an important treatment for hormone-receptor-positive breast cancer because it effectively reduces the chance of cancer recurrence. ^{1 2 6 7 8}

Who Is on the Research Team?

Vered Stearns

Principal Investigator

Eastern Cooperative Oncology Group

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I haven't had a blood clot in my legs or lungs in the last 5 years.

My breast cancer is positive for estrogen or progesterone receptors.

My liver, blood, and kidney functions are good enough for anastrozole treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive anastrozole orally once daily for 12 months

12 months

Monthly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Quarterly visits

What Are the Treatments Tested in This Trial?

Interventions

• Anastrozole

Trial Overview 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.

How Is the Trial Designed?

Group I: Supportive care (anastrozole) Experimental Treatment 1 Intervention

Patients receive anastrozole PO QD for 12 months.

Anastrozole is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Arimidex for:

• Breast cancer
• Early breast cancer in postmenopausal women

Approved in United States as Arimidex for:

• Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
• First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer

Approved in Canada as Arimidex for:

• Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
• Treatment of postmenopausal women with hormone receptor-positive advanced breast cancer

Approved in Japan as Arimidex for:

• Breast cancer

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

Eastern Cooperative Oncology Group

Lead Sponsor

Trials

272

Recruited

153,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8353230/

Aromatase Inhibitor-Associated Musculoskeletal Syndrome The study followed 179 patients who discontinued anastrozole due to AIMSS and were switched to letrozole after a 1-month anastrozole washout ...

2. ascopubs.org ascopubs.org/doi/10.1200/OP.20.00113

Management of Aromatase Inhibitor–Induced ... However, the researchers noted that approximately 8% of women receiving either therapy reported general pain, with 6% reporting bone pain in ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0894113025000080

The effectiveness of hand therapy for breast cancer ... This study demonstrates that hand therapy resulted in statistically and clinically significant improvement in pain, grip strength, upper extremity function,

4. breast-cancer-research.biomedcentral.com breast-cancer-research.biomedcentral.com/articles/10.1186/bcr2818

Aromatase inhibitor-associated bone and musculoskeletal ... Over the 5 years of the study, the median decrease in lumbar spine BMD was -6.08% in the anastrozole-treated group compared with an increase of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8913103/

Effectiveness of intervention for aromatase inhibitor ... In the IBIS-II prevention trial, patients who took anastrozole for 5 years had a significant decrease in bone mineral density. Nearly 10% of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3219175/

Aromatase inhibitor-associated bone and musculoskeletal ... This review will focus on bone and musculoskeletal side effects of aromatase inhibitors, including osteoporosis, fractures, and arthralgias.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0305737209001923

Adjuvant aromatase inhibitor therapy: Outcomes and safety The Anastrozole or Tamoxifen Alone or in Combination (ATAC) trial has compiled safety data for initial adjuvant AI therapy with anastrozole (ANA) versus TAM ...

8. mdpi.com mdpi.com/2227-9059/12/8/1708

Adverse Event Profiles of the Third-Generation Aromatase ... A meta-analysis encompassing 13,000 individuals revealed that the occurrence rate of arthralgia in women treated with AI was between 20–74% [27] ...