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

University of Miami

Status: Enrolling

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

Treatments: Other: Discontinuation of Anti-HER-2 Maintenance Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05959291

20221166

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

anti-HER-2 Group

Experimental group

Description:

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.

Treatment:

Other: Discontinuation of Anti-HER-2 Maintenance Treatment