Breast Cancer Clinical Trial
Official title:
Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer
This a prospective, longitudinal study designed to track edema and Breast Cancer Related Lymphedema (BCRL) onset in breast cancer patients taking targeted therapy treatments for early and metastatic breast cancer. A Perometer and Sozo devise will be used to measure volume changes
Status | Recruiting |
Enrollment | 142 |
Est. completion date | September 30, 2026 |
Est. primary completion date | September 30, 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Subjects who are receiving treatment in the MGH Breast Cancer Center who are enrolled in a DF/HCC-regulated targeted therapy trial for the treatment of early or metastatic breast cancer or patients being treated with a targeted therapy that may alter their risk of developing edema or BCRL will be eligible. - Subjects that will be eligible for the study include: - Females between 18 and 80 years of age - With a history of breast cancer - 4 weeks or more post-surgery - With or without edema - Undergoing treatment with targeted therapy for early or metastatic disease. Exclusion Criteria: - Patients who cannot attain 90 degrees of shoulder abduction (position of measurement with Perometer). |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Heinz Family Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of participants with a greater than or equal to 10% arm volume change from the first pre-treatment (targeted therapy) measurement, detected by perometry, occurring at least three months after breast surgery | Greater than or equal to 10% arm volume change from the first pre-treatment (targeted therapy) measurement, detected by perometry, occurring at least three months after breast surgery | At least three months post surgery up to 5 years, assessed every 3 months | |
Secondary | Time course to lymphedema onset | The cumulative incidence curves of the study and control groups and comparing hazard rates after accounting for important covariates in a multivariate Cox proportional-hazards model | 5 Years | |
Secondary | Correlation of different targeted therapies with lymphedema onset | Comparison of the incidence of lymphedema by type of targeted therapy drug (CDK4/6, PI3K, mTorr). | 5 Years |
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