Clinical trial · Interventional
Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome
Pilot Trial to Evaluate Blood and Imaging Based Biomarkers for Aromatase Inhibitor Induced Musculoskeletal Syndrome
NCT03665077CI-TRIAL-00069053completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a pilot trial to evaluate for blood and imaging biomarkers in patients with breast cancer scheduled to start adjuvant hormonal therapy.
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 |
|---|---|---|---|
| Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS) | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw at six months | Diagnostic Test | — | UNRESOLVED |
| Blood draw at three months | Diagnostic Test | — | UNRESOLVED |
| Initial blood draw | Diagnostic Test | — | UNRESOLVED |
| Initial SWE ultrasound | Diagnostic Test | — | UNRESOLVED |
| SWE ultrasound at six months | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants
- description
- Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy.
- interventionNames
- Diagnostic Test: Initial blood draw
- Diagnostic Test: Initial SWE ultrasound
- Diagnostic Test: Blood draw at three months
- Diagnostic Test: Blood draw at six months
- Diagnostic Test: SWE ultrasound at six months
Primary outcomes (1)
- measure
- Oxylipin Levels
- timeFrame
- Baseline, Three months, and Six months
- description
- Change Oxylipin levels at Baseline, Three and Six Months
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Be capable of understanding the investigational nature of the study and all pertinent aspects of the study 2. Be capable of signing and providing written consent in accordance with institutional and federal guidelines 3. Have a histologically-confirmed diagnosis of breast cancer 4. Be willing and able to comply with scheduled visits, treatment plan, and SWE ultrasound imaging 5. Age ≥ 21 years 6. Post-menopausal women with 1st event of ER+ early stage breast cancer (0-3) 7. Completed definitive therapy (surgery ± radiation) 8. Candidates for adjuvant AI therapy Exclusion Criteria: 1. Have received adjuvant or neo-adjuvant chemotherapy 2. Prior endocrine therapy (AI or tamoxifen) 3. History of rheumatoid arthritis or other autoimmune arthritis 4. Daily non-steroidal anti-inflammatory drug (NSAID) use (except for daily aspirin use) 5. Current use of daily corticosteroids or immunosuppressive therapies
References
Publications (0)
Data not yet available
No reference posted for this study.