NCT05959291Active, not recruiting
Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer
Free-HER: Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 17 Jul 2023
- Start date
- 17 Jul 2023
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- University of Miami
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05959291
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 17 Jul 2023 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are currently receiving or have received treatment for a secondary cancer other than resected non-melanoma skin cancer lesions or in situ cancer within the past 24 months.
- Use of investigational drugs ≤ 28 days prior to study enrollment and during the study.
Other illness
- Patients with uncontrolled metastatic disease.
- Patients whose disease has been controlled for less than 36 months on the same or current anti-HER-2 therapy.
- Patients with impaired decision-making capacity.
- Patients who are found to be ctDNA+ at study entry will be recorded as a screen failure (Section 5.4). Their Signatera testing results will be provided to their treating physician to aid in clinical decision-making for disease management and treatment.
Lab values
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or that makes participation in the trial to be not in the best interest of the patient in the opinion of the Investigator.
Other
- Patients positive for ctDNA (which occurs when a patient's blood sample contains ≥2 target markers) with the Signatera assay.
Who the study is looking for
- Patients with a diagnosis of HER-2 positive metastatic (Stage IV) breast cancer.
- Patients in complete radiological remission (CRR), including a stable bone scan, as determined by computed tomography (CT), positron-emission tomography (PET), or PET-CT.
- Patients with brain metastasis are allowed to participate as long as their disease has been treated and radiologically stable for at least 36 months.
- Patients must be on the same or current anti-HER-2 directed therapy for at least 36 months.
- Archived tumor biopsy available.
- Patients with no evidence of circulating tumor deoxyribonucleic acid (ctDNA) as determined by the Signatera assay.
- Patients willing to stop maintenance anti-HER-2 directed therapy with close monitoring.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance score from 0 to 2.
- Patients ≥ 18 years of age.
- Ability to understand and the willingness to sign a written informed consent document.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.