RecruitingNot Applicable

Screening For BCRL In Targeted Therapy For Breast Cancer

United States261 participantsStarted 2018-12-13

Plain-language 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

Who can participate

Age range

18 Years – 80 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Timeframe: At least three months post surgery up to 5 years, assessed every 3 months

Trial details

NCT IDNCT05142800

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09-30

Contact for this trial

Alphonse G. Taghian, MD

617-643-1306 ataghian@partners.org

View on ClinicalTrials.gov More Lymphedema trials