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

Launched by UNIVERSITY OF MIAMI · Jul 17, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring whether patients with HER2-positive metastatic breast cancer can safely stop their maintenance therapy, like Herceptin, while still keeping their cancer in complete remission. The researchers want to see if these patients can remain cancer-free without treatment and how long this might last. To be eligible for the study, participants need to have been diagnosed with HER2-positive metastatic breast cancer and must have been in complete remission for at least three years while on the same treatment. They also need to be at least 18 years old and have a stable health status.

If you join the trial, you will stop your current maintenance therapy but will be closely monitored with regular imaging tests and blood work to check on your cancer status. This study is open to all genders, and it aims to better understand the possibility of living without ongoing treatment for those who have responded well for an extended period. It's important to note that patients with any signs of active disease or certain blood markers will not be eligible for this study. This research could help improve future treatment options for patients with similar conditions.

Gender

ALL

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.