Clinical trial · Observational
Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients
Prospective Study of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients
NCT01051609CI-TRIAL-00023826completedClinicalTrials.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)
The purpose of this study is to compare pre and post Aromatase Inhibitor (AI) treatment serological markers of inflammation and assess for correlation with AI-MS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Collection | Other | — | UNRESOLVED |
| Grip Strength Measurement | Other | — | UNRESOLVED |
| History and Physical Exam | Other | — | UNRESOLVED |
| Surveys | Behavioral | — | UNRESOLVED |
| Ultrasound of Hand/Wrist | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Intervention Group
- description
- There is only one arm in this trial. Please see interventions for more detailed descriptions.
- interventionNames
- Other: History and Physical Exam
- Other: Grip Strength Measurement
- Behavioral: Surveys
- Other: Blood Collection
- Procedure: Ultrasound of Hand/Wrist
Primary outcomes (1)
- measure
- Presence, severity, and change in severity of pain based on joint exam and joint ultrasound inflammatory score.
- timeFrame
- Study visits at 3, 6, 9 and 12 months after the start of treatment with an Aromatase Inhibitor
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women 18 years and older with non-metastatic hormone receptor (ER and/or PR) positive breast cancer who are eligible for and planning on starting treatment with an AI within one month of signing consent. * Postmenopausal, defined as at least one of the following: a) amenorrhea for at least 12 months b) prior bilateral oophorectomy at least 2 years prior to trial registration. Exclusion Criteria: * History of autoimmune connective tissue disease, such as rheumatoid arthritis, lupus, or other autoimmune conditions affecting joints. * Treatment with steroid (for any condition, except for chemotherapy premedication) within 30 days of trial registration. * Prior treatment with an AI (patients previously or currently on tamoxifen are eligible as long as patients are off tamoxifen for 2 weeks prior to baseline blood draw) * Active or ongoing infection * Known metastatic disease * Known history of HIV or hepatitis infections * Ongoing radiation therapy (radiation must have been completed 2 weeks prior to starting treatment with an AI) * Non-invasive (DCIS, LCIS) cancer only (no diagnosis of invasive cancer) * Pregnant or lactating * Unable to speak, read, and write in English
References
Publications (0)
Data not yet available
No reference posted for this study.