Screening For BCRL In Targeted Therapy For Breast Cancer

Study Overview
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Brief Summary
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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

Detailed Description
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This study will compare patients' relative arm volume changes and symptoms data from before drug therapy throughout drug treatment and for up to six months after treatment has finished. A Perometer and Sozo device will be used to measure volume changes All participants will be accrued at Massachusetts General Hospital for a target accrual of 142 participants

Official Title
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Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer

Conditions
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Lymphedema Arm, Edema, Lymphedema, Lymphedema of Upper Arm, Lymphedema of Upper Limb, Lymphedema of the Hands, Edema Arm, Breast Cancer Lymphedema, Breast Cancer Metastatic, Breast Cancer Stage, Breast Cancer

Intervention / Treatment
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* Device: Perometer
* Device: SOZO device


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Target Therapy Drug-Stand Care<br>Screening procedures confirm participation in the research study. Participants limb volume is measured prior to treatment start date. Participant is provided informational brochure about risk of lymphedema and Lymphedema Screening Program Card. Perometer and SOZO measurements will be incorporated as a part of the follow-up visits throughout the course of their trial and for at least 6 months beyond their last dose of trial medication | Device: Perometer<br>* The perometer uses light sensors to calculate the length and volume of your arms<br>Device: SOZO device<br>* The machine measures the amount of fluid on the arm(s)<br>|
| Target Therapy-Early or Metastatic Breast Cancer<br>Screening procedures confirm participation in the research study. Participants limb volume is measured prior to treatment start date. Participant is provided informational brochure about risk of lymphedema and Lymphedema Screening Program Card. Perometer and SOZO measurements will be incorporated as a part of the follow-up visits throughout the course of their trial and for at least 6 months beyond their last dose of trial medication | Device: Perometer<br>* The perometer uses light sensors to calculate the length and volume of your arms<br>Device: SOZO device<br>* The machine measures the amount of fluid on the arm(s)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphedema, Lymphedema Arm, Lymphedema of Upper Arm, Lymphedema of Upper Limb, Lymphedema of the Hands, Edema, Edema Arm, Breast Cancer Lymphedema, Breast Cancer Metastatic, Breast Cancer Stage, Breast Cancer