HER2-positive Metastatic Breast CancerFree-HERNCT05959291
Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer
A study testing Discontinuation of Anti-HER-2 Maintenance Treatment in people with HER2-positive Metastatic Breast Cancer and Stage IV Breast Cancer, run by University of Miami at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Metastatic Breast Cancer, Stage IV Breast Cancer
- What is being tested?
- Discontinuation of Anti-HER-2 Maintenance Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2023to 31 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 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.
- Patients positive for ctDNA (which occurs when a patient's blood sample contains ≥2 target markers) with the Signatera assay.
- Use of investigational drugs ≤ 28 days prior to study enrollment and during the study.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Free-HER: Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer
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.
- Being tested
- Discontinuation of Anti-HER-2 Maintenance Treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of Anti-HER-2 Maintenance TreatmentOther
Patients assigned to this group will be asked to discontinue anti-HER-2 maintenance treatment.
| Study group | Role | What they receive |
|---|---|---|
| anti-HER-2 Group | Experimental | Participants in this group will be monitored to see if patients discontinuing maintenance of anti-HER-2 treatments with ctDNA monitoring in addition to radiologic imaging and routine blood work will stay in complete radiological remission. Participants will be in this group for up to 3 years. Receives: Other: Discontinuation of Anti-HER-2 Maintenance Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of maintaining remission after discontinuing use of anti-HER-2
The feasibility of maintaining remission of HER-2 will be measured as the proportion of patients who discontinue anti-HER-2 therapy and who remain in remission is assessed by monitoring ctDNA in the blood.
Measured: Up to 72 months
Secondary outcomes (3)
Ability of re-attain remission after ctDNA+ status
Ability to re-attain remission after ctDNA+ status is defined as returning to ctDNA- status within 6 months after testing ctDNA+ during the study. This is assessed by the monitoring of ctDNA in the blood of participants that have tested ctDNA positive after stopping anti-HER-2 maintenance therapy and chose to restart anti-HER-2 therapy.
Measured: Up to 72 months
Duration of response (DOR)
The duration of response (DOR) in study participants that have restarted anti-HER-2 therapy measures the time from is ctDNA+ status to overall response rate (ORR). This includes study participants that have ctDNA+ status and have chosen to either restart their previous anti-HER-2 maintenance therapy or have started a new anti-HER-2 therapy. The ORR is determined by blood and imaging monitoring.
Measured: Up to 72 months
Diagnostic Accuracy of ctDNA Monitoring Assay to Identify Disease Progression
Diagnostic accuracy is evaluated by comparing disease relapse and/or progression confirmed by imaging compared to study participants ctDNA status.
Measured: Up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start17 Jul 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Krill Jackson, University of Miami
- Investigators
- Elisa Krill Jackson, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959291
- Sponsor's protocol ID
- 20221166
- Other IDs
- NCI-2023-03606
- Acronym
- Free-HER
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free-HER: Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT05959291
- Acronym / sponsor ID
- Free-HER / 20221166
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-HER-2 Group | Experimental | Other: Discontinuation of Anti-HER-2 Maintenance TreatmentParticipants in this group will be monitored to see if patients discontinuing maintenance of anti-HER-2 treatments with ctDNA monitoring in addition to radiologic imaging and routine blood work will stay in complete radiological remission. Participants will be in this group for up to 3 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 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.
Key exclusion criteria (8 listed)
- 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 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.
- Patients positive for ctDNA (which occurs when a patient's blood sample contains ≥2 target markers) with the Signatera assay.
- Use of investigational drugs ≤ 28 days prior to study enrollment and during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinuation of Anti-HER-2 Maintenance TreatmentPatients assigned to this group will be asked to discontinue anti-HER-2 maintenance treatment. | Other | anti-HER-2 Group |
Primary outcome
Feasibility of maintaining remission after discontinuing use of anti-HER-2
Time frame: Up to 72 months
The feasibility of maintaining remission of HER-2 will be measured as the proportion of patients who discontinue anti-HER-2 therapy and who remain in remission is assessed by monitoring ctDNA in the blood.
3 secondary outcomes
Ability of re-attain remission after ctDNA+ status
Time frame: Up to 72 months
Duration of response (DOR)
Time frame: Up to 72 months
Diagnostic Accuracy of ctDNA Monitoring Assay to Identify Disease Progression
Time frame: Up to 72 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa Krill Jackson, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discontinuation of Anti-HER-2 Maintenance Treatment in people with HER2-positive Metastatic Breast Cancer and Stage IV Breast Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of maintaining remission after discontinuing use of anti-HER-2 (time frame: Up to 72 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.