Screening For BCRL In Targeted Therapy For Breast Cancer
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
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - 80 years
- Sex eligible
- Female
- Healthy volunteers
- Not accepted
- Participants
- 261 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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 population
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.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
Target Therapy Drug-Stand Care
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 · Device: SOZO device
Target Therapy-Early or Metastatic Breast Cancer
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 · Device: SOZO device
Perometer DEVICE
The perometer uses light sensors to calculate the length and volume of your arms
SOZO device DEVICE
The machine measures the amount of fluid on the arm(s)
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary 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 surgery
Time frame: 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 measures
To assess the time course to lymphedema onset
Time frame: 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
Time frame: 5 Years
We will compare the incidence of lymphedema by type of targeted therapy drug (CDK4/6, PI3K, mTOR, AKT).
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Massachusetts General HospitalBoston, Massachusetts, United StatesRecruiting
Study team and timeline
- Lead sponsor
- Massachusetts General Hospital
- Study start
- Dec 13, 2018 Actual
- Primary completion
- Sep 30, 2027 Estimated
- Study completion
- Sep 30, 2027 Estimated
- First posted
- Dec 3, 2021 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026