Stopping HER-2 treatment in long-term survivors of metastatic breast cancer

Free-HER: Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer

This study is testing if people with HER-2 positive metastatic breast cancer can safely stop their treatment after reaching complete remission and still stay in remission without ongoing therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Miami (Academic / other)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT05959291 on ClinicalTrials.gov

What this trial studies

This research investigates whether patients with HER-2 positive metastatic breast cancer can safely discontinue maintenance therapy after achieving complete radiological remission. Participants will undergo close monitoring, including imaging and blood work, to assess their remission status after stopping treatment. The study aims to determine how long these patients can maintain remission without ongoing therapy.

Who should consider this trial

Good fit: Ideal candidates are adults with HER-2 positive metastatic breast cancer who have been in complete radiological remission for at least 36 months and are willing to stop maintenance therapy.

Not a fit: Patients who are not in complete remission or have evidence of circulating tumor DNA may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could allow patients to avoid the side effects of long-term HER-2 therapy while maintaining remission.

How similar studies have performed: While there have been studies on treatment discontinuation in other cancers, this specific approach for HER-2 positive metastatic breast cancer is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patients with a diagnosis of HER-2 positive metastatic (Stage IV) breast cancer.
2. Patients in complete radiological remission (CRR), including a stable bone scan, as determined by computed tomography (CT), positron-emission tomography (PET), or PET-CT.

   a. Patients with brain metastasis are allowed to participate as long as their disease has been treated and radiologically stable for at least 36 months.
3. Patients must be on the same or current anti-HER-2 directed therapy for at least 36 months.
4. Archived tumor biopsy available.
5. Patients with no evidence of circulating tumor deoxyribonucleic acid (ctDNA) as determined by the Signatera assay.
6. Patients willing to stop maintenance anti-HER-2 directed therapy with close monitoring.
7. Patients with an Eastern Cooperative Oncology Group (ECOG) performance score from 0 to 2.
8. Patients ≥ 18 years of age.
9. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients with uncontrolled metastatic disease.
2. Patients whose disease has been controlled for less than 36 months on the same or current anti-HER-2 therapy.
3. 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.
4. Patients positive for ctDNA (which occurs when a patient's blood sample contains ≥2 target markers) with the Signatera assay.
5. Use of investigational drugs ≤ 28 days prior to study enrollment and during the study.
6. 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.
7. 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.

Where this trial is running

Miami, Florida

• University of Miami — Miami, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Elisa Krill Jackson, MD — University of Miami
• Study coordinator: Elisa Krill Jackson, MD

Conditions HER2-positive Metastatic Breast Cancer; Stage IV Breast Cancer