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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Lymphedema; Edema; Lymphedema of Upper Arm; Breast Cancer Lymphedema; Breast Cancer Metastatic; Lymphedema of Upper Limb; Breast Cancer Stage; Lymphedema Arm; Edema Arm; Lymphedema of the Hands
• Intervention / Treatment: Device: Perometer; Device: SOZO device

Detailed 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 142 participants

• Study Type: Observational
• Enrollment (Estimated): 142

Contacts and Locations

• Study Contact: Name: Alphonse G. Taghian, MD; Phone Number: 617-643-1306; Email: ataghian@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Alphonse G. Taghian, MD; Phone Number: 617-643-1306; Email: ataghian@partners.org
      • Principal Investigator: Alphonse G. Taghian, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The perometer uses light sensors to calculate the length and volume of your arms; Device: SOZO device; The machine measures the amount of fluid on the arm(s)
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; The perometer uses light sensors to calculate the length and volume of your arms; Device: SOZO device; The machine measures the amount of fluid on the arm(s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time course to lymphedema onset	The 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	5 Years
Correlation of different targeted therapies with lymphedema onset	Comparison of the incidence of lymphedema by type of targeted therapy drug (CDK4/6, PI3K, mTorr).	5 Years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Heinz Family Foundation
• Investigators: Principal Investigator: Alphonse G. Taghian, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2018
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Lymphedema; Breast Cancer; Edema; Lymphedema of Upper Limb; Breast Cancer Metastatic; Breast Cancer Lymphedema; Lymphedema Arm; Lymphedema of Upper Arm; Lymphedema of the Hands; Edema Arm; Breast Cancer Stage
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Edema; Breast Cancer Lymphedema
• Other Study ID Numbers: 18-195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes