Clinical trial · Observational
Observational Study to Evaluate Mechanisms of Aromatase Inhibitor Associated Musculoskeletal Symptoms
Prospective Observational Study of Breast Cancer Patients Starting Therapy With an AI to Evaluate Mechanisms Underlying Development of Aromatase Inhibitor Associated Musculoskeletal Symptoms
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. This observational study is designed to collect patient-reported outcomes and serial serum samples in order to investigate potential etiologies of this bothersome toxicity.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arthralgia | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Aromatase inhibitor therapy
- description
- Subjects who are starting treatment with any of the three aromatase inhibitor (AI) medications
Primary outcomes (1)
- measure
- Change in estradiol and development of musculoskeletal symptoms between baseline and 3 months
- timeFrame
- 12 months
- description
- To identify associations between estradiol serum concentrations at baseline and after 3 months of aromatase inhibitor therapy and the development of aromatase inhibitor-associated musculoskeletal symptoms by 12 months
Secondary outcomes (1)
- measure
- Change in sex hormones and development of musculoskeletal symptoms between baseline and 3 months
- timeFrame
- 12 months
- description
- To identify associations between change in estrogens and androgens at baseline and 3 months of aromatase inhibitor therapy and development of aromatase inhibitor-associated musculoskeletal symptoms by 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Stage I-III breast cancer who are scheduled to receive endocrine therapy with an aromatase inhibitor * All prior surgery, chemotherapy, and radiation therapy should be complete or should be completed by the time of AI treatment initiation (within 28 days of study enrollment) * Age 21 and above and postmenopausal
References
Publications (0)
Data not yet available