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NCT05959291 | RECRUITING | HER2-positive Metastatic Breast Cancer

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

University of Miami

Information provided by (Responsible Party):

Elisa Krill Jackson

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.

Condition or disease

HER2-positive Metastatic Breast Cancer

Stage IV Breast Cancer

Intervention/treatment

Discontinuation of Anti-HER-2 Maintenance Treatment

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Free-HER: Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer
Actual Study Start Date : 2023-07-17
Estimated Primary Completion Date : 2026-07-31
Estimated Study Completion Date : 2029-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer

Location Details

NCT05959291

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Locations

RECRUITING

United States, Florida

University of Miami

Miami, Florida, United States, 33136