Clinical trial · Observational
A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms
E1Z11 A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor, AIMSS
- 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)
Breast cancer is one of the most prevalent cancers with 207,090 new cases of breast cancer and 39,840 deaths in women predicted for 2010 in the United States. Aromatase inhibitors (AIs) are used as first-line adjuvant therapy for postmenopausal women with early stage breast cancer. The effectiveness of current therapy is widely recognized to be compromised by poor compliance because of aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), a syndrome that affects up to 40-50% of women who take these medications. The syndrome that was not recognized during the registration trials for this class of drugs, it can lead to discontinuation in up to 24% of women over 2 years. Knowledge that can be used to prevent discontinuation of these important agents because of severe AIMSS is urgently needed.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| surveys completed by subject | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Caucasian
- description
- surveys completed by subject n=600, nationally
- interventionNames
- Other: surveys completed by subject
- label
- African-American
- description
- surveys completed by subject n=200, nationally
- interventionNames
- Other: surveys completed by subject
- label
- Asian
- description
- surveys completed by subject n=200, nationally
- interventionNames
- Other: surveys completed by subject
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 60 years of age; or * \< 60 years of age and amenorrheic for ≥ 12 months prior to day 1 if uterus/ovaries are intact; or * \< 60 years of age, and the last menstrual period 6-12 months prior to day 1, if intact uterus/ovaries and meets biochemical criteria for menopause (FSH and estradiol within institutional standard for postmenopausal status); or * \< 60 years of age, without a uterus, and meets biochemical criteria for menopause (FSH and estradiol within institutional standards for postmenopausal status); or * \< 60 years of age and history of bilateral oophorectomy. Surgery must have been completed at least 4 weeks prior to day 1; or * Prior radiation castration with amenorrhea for at least 6 months.
References
Publications (0)
Data not yet available