Screening For BCRL In Targeted Therapy For Breast Cancer
Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer
1 other identifier
observational
166
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 13, 2018
CompletedFirst Submitted
Initial submission to the registry
November 15, 2021
CompletedFirst Posted
Study publicly available on registry
December 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
May 22, 2025
May 1, 2025
7.8 years
November 15, 2021
May 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
Secondary Outcomes (2)
To assess the time course to lymphedema onset
5 Years
To asses the correlation of different targeted therapies with lymphedema onset
5 Years
Study Arms (2)
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
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
Interventions
The perometer uses light sensors to calculate the length and volume of your arms
The machine measures the amount of fluid on the arm(s)
Eligibility 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.
You may qualify if:
- 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
- weeks or more post-surgery
- With or without edema
- Undergoing treatment with targeted therapy for early or metastatic disease.
You may not qualify if:
- \- Patients who cannot attain 90 degrees of shoulder abduction (position of measurement with Perometer).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Heinz Family Foundationcollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alphonse G. Taghian, MD
Massachusetts General Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 15, 2021
First Posted
December 3, 2021
Study Start
December 13, 2018
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
May 22, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.