Screening For BCRL In Targeted Therapy For Breast Cancer

Breast Cancer Clinical Trial

Official title:

Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05142800
• Other study ID #: 18-195
• Status: Recruiting
• Start date: December 13, 2018
• Est. completion date: September 30, 2026

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Alphonse G. Taghian, MD
• Phone: 617-643-1306
• Email: ataghian[@]partners.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Lymphedema
• Breast Cancer Metastatic
• Breast Cancer Stage
• Breast Neoplasms
• Edema
• Edema Arm
• Lymphedema
• Lymphedema Arm
• Lymphedema of Upper Arm
• Lymphedema of Upper Limb

Intervention

Device:
• Perometer
The perometer uses light sensors to calculate the length and volume of your arms
• SOZO device
The machine measures the amount of fluid on the arm(s)

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Heinz Family Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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