Actively Recruiting
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
315 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this preliminary research study is to see if patients discontinuing maintenance Herceptin and/or other anti-HER-2 treatments with monitoring in addition to radiologic imaging and routine blood work will stay in complete radiological remission and to determine how long patients are able to stay in complete radiological remission without treatment.
CONDITIONS
Official 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...
- Patients diagnosed with HER-2 positive metastatic (Stage IV) breast cancer
- Patients in complete radiological remission confirmed by CT, PET, or PET-CT scans, including stable bone scans
- Patients with treated and stable brain metastasis for at least 36 months may participate
- Patients on the same or current anti-HER-2 therapy for at least 36 months
- Archived tumor biopsy available
- No evidence of circulating tumor DNA (ctDNA) per the Signatera assay
- Willing to stop maintenance anti-HER-2 therapy with close monitoring
- Eastern Cooperative Oncology Group (ECOG) performance score between 0 and 2
- Age 18 years or older
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Patients with uncontrolled metastatic disease
- Disease controlled for less than 36 months on current anti-HER-2 therapy
- Current or recent (within 24 months) treatment for a secondary cancer except resected non-melanoma skin lesions or in situ cancer
- Positive for circulating tumor DNA (ctDNA) by Signatera assay
- Use of investigational drugs within 28 days before enrollment or during the study
- Any condition, therapy, or lab abnormality that interferes with participation or study results
- Impaired decision-making capacity
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
E
Elisa Krill Jackson, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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