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Screening for Lymphedema in Breast Cancer Patients on Targeted Therapy

This study is looking at how often breast cancer patients receiving targeted therapy develop swelling (edema) or breast cancer-related lymphedema (BCRL). Researchers will use two devices, the Perometer and SOZO, to measure arm volume changes in women aged 18 to 80 who are undergoing targeted therapy for early or metastatic breast cancer at Massachusetts General Hospital. The main goal is to see what percentage of participants have a 10% or more increase in arm volume, detected by the Perometer, at least three months after breast surgery and up to five years later. The study's current status is unclear.

Study design
This is an observational study designed to track changes in arm volume over time. It aims to enroll 261 participants.
What's involved
You would have your arm volume measured using a Perometer and SOZO device before, during, and for up to six months after your targeted therapy treatment. These measurements will be taken every three months for up to five years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to five years after breast surgery, with measurements taken every three months.

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NCT05142800

Screening For BCRL In Targeted Therapy For Breast Cancer

Recruiting
Not specifiedAges 18–80Observational
Massachusetts General Hospital
~261 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:PerometerSOZO device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over At least three months post surgery up to 5 years, assessed every 3 months

Conditions

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

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Breast CarcinomaLymphedema

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Alphonse G. Taghian, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Alphonse G. Taghian, MD
[email protected]
617-643-1306
Email the study team

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Eligibility criteria

Inclusion

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.

What this trial measures

  • 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 surgeryAt 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