Clinical trial NCT05959291: Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer
Official title: Free-HER: Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HER2-positive Metastatic Breast Cancer
Stage IV Breast Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Feasibility of maintaining remission after discontinuing use of anti-HER-2
timeFrame: Up to 72 months
Secondary outcomes:
measure: Ability of re-attain remission after ctDNA+ status
timeFrame: Up to 72 months
measure: Duration of response (DOR)
timeFrame: Up to 72 months
measure: Diagnostic Accuracy of ctDNA Monitoring Assay to Identify Disease Progression
timeFrame: Up to 72 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Elisa Krill Jackson, MD
role: PRINCIPAL_INVESTIGATOR
References: