Observational Study to Evaluate Mechanisms of Aromatase Inhibitor Associated Musculoskeletal Symptoms

NCT02118636 | Completed

• 1 other identifier: UMCC 2009.057
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Arthralgia

Keywords

Joint pain; Hormone receptor positive breast cancer; Estrogen; Androgen

Outcome Measures

Primary Outcomes (1)

• Change in estradiol and development of musculoskeletal symptoms between baseline and 3 months

  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

  12 months

Secondary Outcomes (1)

• Change in sex hormones and development of musculoskeletal symptoms between baseline and 3 months

  12 months

Study Arms (1)

Aromatase inhibitor therapy

Subjects who are starting treatment with any of the three aromatase inhibitor (AI) medications

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal women with hormone receptor positive breast cancer who are initiating therapy with an aromatase inhibitor

You may qualify if:

• 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

Sponsors & Collaborators

• Lynn Henry: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood is being collected at baseline for DNA extraction. Serum is being collected at baseline and after 3, 6, and 12 months.

MeSH Terms

Conditions

Breast Neoplasms; Arthralgia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Norah L Henry, MD, PhD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: April 21, 2014
• Study Start: October 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2015
• Last Updated: March 7, 2016

Record last verified: 2016-03

Locations

US (1)