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