A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms

NCT02874222 | Completed DMC

• 1 other identifier: NMCSD.2014.0053
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

aromatase inhibitors

Outcome Measures

Primary Outcomes (1)

• development of arthritic symptoms

  patients surveyed and given physical exams

  12 months

Study Arms (3)

Caucasian

surveys completed by subject n=600, nationally

Other: surveys completed by subject

African-American

surveys completed by subject n=200, nationally

Other: surveys completed by subject

Asian

surveys completed by subject n=200, nationally

Other: surveys completed by subject

Interventions

surveys completed by subject OTHER

Cohort study designed to validate previously identified associations between 10 specific SNPs and discontinuation of treatment with AIs due to the development of MSS among women with breast cancer.

African-American; Asian; Caucasian

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

breast cancer patients

You may qualify if:

• ≥ 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.

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead
• Alliance for Clinical Trials in Oncology: collaborator

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Preston Gable, MD

  Site PI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 22, 2016
• Study Start: May 1, 2015
• Primary Completion: July 1, 2023
• Study Completion: May 1, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)