Observational Study to Evaluate Mechanisms of Aromatase Inhibitor Associated Musculoskeletal Symptoms
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Cancer, Orthopedic |
Therapuetic Areas: | Oncology, Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 4/21/2016 |
Start Date: | October 2009 |
End Date: | September 2015 |
Prospective Observational Study of Breast Cancer Patients Starting Therapy With an AI to Evaluate Mechanisms Underlying Development of Aromatase Inhibitor Associated Musculoskeletal Symptoms
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.
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.
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
We found this trial at
1
site
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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