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Trial Title:
Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer
NCT ID:
NCT05959291
Condition:
HER2-positive Metastatic Breast Cancer
Stage IV Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Discontinuation of Anti-HER-2 Maintenance Treatment
Description:
Patients assigned to this group will be asked to discontinue anti-HER-2 maintenance
treatment.
Arm group label:
anti-HER-2 Group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elisa Krill Jackson, MD
Phone:
305-689-6500
Email:
ekrill@med.miami.edu
Contact backup:
Last name:
Elisa Krill Jackson, MD
Start date:
July 17, 2023
Completion date:
July 31, 2029
Lead sponsor:
Agency:
University of Miami
Agency class:
Other
Source:
University of Miami
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05959291
