82 Participants NeededMy employer runs this trial

TheraBionic P1 for Breast Cancer

Recruiting at 7 trial locations
HA
Overseen ByHadeel Assad, M.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Barbara Ann Karmanos Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if the TheraBionic P1 device given to patients with advanced or metastatic HR positive, HER2 negative breast cancer who have progressed on standard of care options can affect patients survival. The main questions it aims to answer are:

* will the TheraBionic P1 device affect progression free and overall survival in advanced or metastatic HR positive, HER2 negative breast cancer

* the long term safety and tolerability of the TheraBionic P1 device

* assessment of how the disease responded to the TheraBionic P1 device

Are You a Good Fit for This Trial?

This trial is for women aged 22 or older with advanced or metastatic hormone-positive, HER2-negative breast cancer who have already tried and not benefited from all standard treatments. Participants must be able to care for themselves, have at least a 3-month life expectancy, and agree to avoid pregnancy during the study.

Inclusion Criteria

My breast cancer is advanced, HR positive, and HER2 negative.
I have tried and not responded to all standard treatments, including hormone therapy, CDK4/6 inhibitors, and chemotherapy or ADCs.
I am a woman, at least 22 years old, and can give informed consent.
See 7 more

What Are the Treatments Tested in This Trial?

Interventions

  • TheraBionic P1

Trial Overview

The study is testing the TheraBionic P1 device in women with advanced HR positive, HER2 negative breast cancer that has stopped responding to other treatments. The main goals are to see if it helps patients live longer and how safe it is over time.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: TheraBionic P1 deviceExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Barbara Ann Karmanos Cancer Institute

Lead Sponsor

Trials
166
Recruited
9,300+