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NCT Number: NCT05142800

Screening For BCRL In 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

Recruiting

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Key information

Conditions

Lymphedema Breast Cancer Breast Cancer Lymphedema Breast Cancer Metastatic Breast Cancer Stage Breast Diseases Breast Neoplasms Edema Edema Arm Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Arm Lymphedema of Upper Arm Lymphedema of Upper Limb Lymphedema of the Hands Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Alphonse G. Taghian, MD

CONTACT

[email protected]

617-643-1306

Alphonse G. Taghian, MD

PRINCIPAL_INVESTIGATOR

About this study

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 166 participants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Perometer

Device

The perometer uses light sensors to calculate the length and volume of your arms

SOZO device

Device

The machine measures the amount of fluid on the arm(s)

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

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

    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

Secondary outcomes

  1. To assess the time course to lymphedema onset

    Time frame: 5 Years

    We will also attempt to look at any time course differences of lymphedema onset by plotting 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.

  2. To asses the correlation of different targeted therapies with lymphedema onset

    Time frame: 5 Years

    We will compare the incidence of lymphedema by type of targeted therapy drug (CDK4/6, PI3K, mTOR, AKT).

Study contacts

Contact information is provided by the study sponsor or research team.

Alphonse G. Taghian, MD

CONTACT

[email protected]

617-643-1306

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Heinz Family Foundation

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Dec 3, 2021
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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