An Observational Clinical Study to Evaluate the Role of MRD in the Prediction of Local Therapy in Patients With Oligometastatic Breast Cancer.
This is an observational clinical study of MRD as a predictor of local treatment in patients with oligometastatic breast cancer. The aim of the study is to assess the correlation between MRD levels and prognosis in patients with oligometastatic breast cancer who have undergone local treatment in order to identify the population that would benefit from local treatment and to develop an individualised treatment plan. Subjects will agree to participate in this study and will be asked to collect as much medical history and demographic information as possible prior to enrolment to confirm that they meet the inclusion/exclusion criteria, and that they will undergo imaging and MRD testing prior to their first study treatment. Furthermore, subjects will undergo tumour imaging and MRD testing every 3 months (±7 days) after MRD treatment for the duration of the study, with additional investigations or more frequent tumour imaging evaluations as clinically indicated during the study.
• Histologically or cytologically confirmed breast cancer.
• Previously confirmed metastatic breast cancer by imaging.
• Eastern Cooperative Oncology Group (ECOG) physical status score of 0-2. (4) Age ≥ 18 years at the time of signing the informed consent form. (5) Subjects willing and able to comply with the study protocol throughout the study period.
⁃ (6) Female subjects of childbearing potential must agree to use a highly effective method of contraception during the study.
⁃ (7) Voluntarily agree to and sign a written informed consent form and be willing and able to comply with all aspects of the trial protocol, which can be withdrawn by the patient at any time without prejudice.