Screening For BCRL In Targeted Therapy For Breast Cancer

Overseen By Alphonse G. Taghian, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Targeted therapy

Disqualifiers: Limited shoulder mobility

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Variable, based on individual treatment plans

166 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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

Who Is on the Research Team?

Alphonse G. Taghian, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

With a history of breast cancer

4 weeks or more post-surgery

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive targeted therapy treatments for early and metastatic breast cancer

Variable, based on individual treatment plans

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, with limb volume measurements using Perometer and SOZO

6 months

Follow-up visits every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Perometer
• SOZO device

How Is the Trial Designed?

Group I: Target Therapy-Early or Metastatic Breast Cancer Experimental Treatment 2 Interventions

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

Group II: Target Therapy Drug-Stand Care Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Heinz Family Foundation

Collaborator

Trials

3

Recruited

310+