Actively Recruiting
Free-HER: Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer
Led by University of Miami · Updated on 2025-08-13
20
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates whether patients with metastatic HER-2 positive breast cancer who have been in complete radiological remission can safely stop maintenance anti-HER-2 treatments. It aims to find out how long these patients remain in remission without ongoing treatment, using monitoring methods like radiologic imaging, routine blood work, and circulating tumor DNA (ctDNA) testing. The study is a preliminary, interventional trial sponsored by the University of Miami. Participants will stop their current anti-HER-2 maintenance therapy and will be closely monitored through regular imaging scans, blood tests, and ctDNA assessments using the Signatera assay. The study group will be followed for up to three years to observe if remission is maintained without treatment, and researchers will evaluate the feasibility of this discontinuation approach. During the study, participants will undergo periodic radiologic evaluations and blood tests to track remission status and detect any disease progression early. The primary outcome is to assess if remission can be maintained after stopping anti-HER-2 therapy over a period of up to 72 months. Secondary outcomes include the ability to regain remission if ctDNA becomes positive, duration of response, and accuracy of ctDNA monitoring. Participants are involved in close observation and follow-up throughout the study period.
CONDITIONS
Brief Title
Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of HER-2 positive metastatic (Stage IV) breast cancer
- Complete radiological remission, including a stable bone scan, confirmed by CT, PET, or PET-CT
- Patients with brain metastasis allowed if stable and treated for at least 36 months
- On the same or current anti-HER-2 therapy for at least 36 months
- Archived tumor biopsy available
- Negative for circulating tumor DNA (ctDNA) by the Signatera assay
- Willingness to stop maintenance anti-HER-2 therapy with close monitoring
- ECOG performance score between 0 and 2
- Age 18 years or older
- Ability to understand and sign informed consent
You will not qualify if you...
- Uncontrolled metastatic disease
- Disease controlled for less than 36 months on current anti-HER-2 therapy
- Treatment for secondary cancer within past 24 months, except certain skin or in situ cancers
- Positive for ctDNA by Signatera assay at study entry
- Use of investigational drugs within 28 days prior to and during the study
- Any condition or therapy that may interfere with participation or study results
- Impaired decision-making capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 years
Participants will stop their maintenance anti-HER-2 therapy and be closely monitored to see if they remain in complete radiological remission.
Regular monitoring with ctDNA testing, radiologic imaging, and routine blood work
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
E
Elisa Krill Jackson, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here