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

NCT ID: NCT05959291

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-17
• Study Completion Date: 2029-07-31

Brief 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 complete radiological remission without treatment.

Conditions

HER2-positive Metastatic Breast Cancer; Stage IV Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

anti-HER-2 Group

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.

Group Type: EXPERIMENTAL

Discontinuation of Anti-HER-2 Maintenance Treatment

Intervention Type: OTHER

Patients assigned to this group will be asked to discontinue anti-HER-2 maintenance treatment.

Interventions

Discontinuation of Anti-HER-2 Maintenance Treatment

Patients assigned to this group will be asked to discontinue anti-HER-2 maintenance treatment.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Elisa Krill Jackson

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elisa Krill Jackson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elisa Krill Jackson, MD

Role: CONTACT

ekrill@med.miami.edu

305-689-6500

Facility Contacts

Elisa Krill Jackson, MD

Role: primary

ekrill@med.miami.edu

305-689-6500

Other Identifiers

20221166

Identifier Type: -

Identifier Source: org_study_id