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Screening For BCRL In Targeted Therapy For Breast Cancer

ConditionsLymphedemaLymphedema ArmLymphedema of Upper ArmLymphedema of Upper LimbLymphedema of the HandsEdemaEdema ArmBreast Cancer LymphedemaBreast Cancer MetastaticBreast Cancer StageBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-80
SponsorMassachusetts General Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Females between 18 and 80 years of age

With a history of breast cancer

4 weeks or more post-surgery

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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)

Treatment groups

261 Participants
are divided into 2 treatment groups
Group A: Target Therapy Drug-Stand Care2 interventions
Group B: Target Therapy-Early or Metastatic Breast Cancer2 interventions

Trial outcomes

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

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

Secondary outcomes

1

To assess the time course to lymphedema onset

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.

Time frame
5 Years
2

To asses the correlation of different targeted therapies with lymphedema onset

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

Time frame
5 Years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Heinz Family Foundation

Collaborator

Source ClinicalTrials.gov
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