Screening for Breast Cancer-Related Lymphedema in Targeted Therapy
Official title: Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer
Run by Massachusetts General Hospital · NCT05142800 · Data updated 2026-11-12
This study tests whether targeted breast cancer therapies are linked to lymphedema by tracking arm volume and symptoms in women undergoing treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | Women only |
| Enrollment | 261 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | December 13, 2018 |
| Main results expected | September 30, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT05142800 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18–80 with a history of breast cancer, 4 weeks or more post-surgery, starting or on targeted therapy for early or metastatic disease, with or without edema.
✕Probably not a fit
Patients who do not develop edema or who do not experience measurable arm volume changes may see no direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, longitudinal study conducted at Massachusetts General Hospital to monitor the onset of breast cancer–related lymphedema (BCRL) in patients receiving targeted therapies for early or metastatic breast cancer. Researchers will measure arm volume changes using a Perometer and SOZO device from before treatment, throughout therapy, and for up to six months after treatment ends. The study aims to compare relative arm volume changes with reported symptoms to identify early indicators of edema. Approximately 166 participants will be enrolled under DF/HCC-regulated protocols at MGH.
Why it matters
Potential benefit: If successful, the study could help identify early signs of BCRL in patients on targeted therapy, enabling earlier management.
How similar studies have gone: Prior research has used similar volume-tracking tools to monitor edema; this study applies the approach to targeted therapy–associated risk in a single center.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
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Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Alphonse G. Taghian, MD — Massachusetts General Hospital
- Study coordinator: Alphonse G. Taghian, MD
- Email: ataghian@partners.org
- Phone: 617-643-1306
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.