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

NCT05959291 | Recruiting DMC

• 1 other identifier: 20221166
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 72 months

Secondary Outcomes (3)

• Ability of re-attain remission after ctDNA+ status

  Up to 72 months

• Duration of response (DOR)

  Up to 72 months

• Diagnostic Accuracy of ctDNA Monitoring Assay to Identify Disease Progression

  Up to 72 months

Study Arms (1)

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.

Other: Discontinuation of Anti-HER-2 Maintenance Treatment

Interventions

Discontinuation of Anti-HER-2 Maintenance Treatment OTHER

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

anti-HER-2 Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elisa Krill Jackson, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Krill Jackson, MD

CONTACT

305-689-6500; ekrill@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 25, 2023
• Study Start: July 17, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2029
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)