Screening For BCRL In Targeted Therapy For Breast Cancer

Active, not recruiting

• Conditions: Lymphedema Arm; Breast Cancer Metastatic; Breast Cancer Stage; Lymphedema of the Hands; Breast Cancer Lymphedema; Breast Cancer; Lymphedema of Upper Limb; Edema; Lymphedema; Lymphedema of Upper Arm
• Interventions: Device: Perometer; Device: SOZO device

• Registration Number: NCT05142800
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

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 166 participants.

Study Timeline

• Study Start: 2018-12-13
• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 166

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Target Therapy-Early or Metastatic Breast Cancer	Perometer	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
Target Therapy Drug-Stand Care	Perometer	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
Target Therapy Drug-Stand Care	SOZO device	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
Target Therapy-Early or Metastatic Breast Cancer	SOZO device	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

Primary Outcome Measures

Name	Time	Method
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	At least three months post surgery up to 5 years, assessed every 3 months	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

Secondary Outcome Measures

Name	Time	Method
To assess the time course to lymphedema onset	5 Years	We will also attempt to look at any time course differences of lymphedema onset by plotting 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.
To asses the correlation of different targeted therapies with lymphedema onset	5 Years	We will compare the incidence of lymphedema by type of targeted therapy drug (CDK4/6, PI3K, mTOR, AKT).

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States