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.
Patients with active/refractory infections that require ongoing anti-infective therapy.
Severe cardiovascular compromise (history of congestive heart failure greater than New York Heart Association (NYHA) class II), unstable angina or myocardial infarction within the past 6 months, or severe arrhythmia.
Subjects with allogeneic organ transplants requiring immunosuppressive therapy. (4) Subjects known to be human immunodeficiency virus (HIV) positive.
The overall study proposes to enrol patients with no more than five lesions of systemic metastases from breast cancer, which may not be confined to the same organ (with the exception of brain metastases), who have stable control of systemic disease, and who are proposed to be treated locally.
Case-only
Prospective
local treatment
Diagnostic testTumour somatic mutations were identified by 1021 panel sequencing of tumour tissues from cancer patients, and up to 20 mutations were selected as follow-up monitoring loci based on the tumour somatic variants of the patients, and a personalised panel was designed and customised.Post-operative blood from patients was analysed for recurrence risk stratification and drug indications using a combination of personalised panel and a cancer-specific core panel (\~5 kb) stacked on top of each other. The postoperative blood of patients was subjected to cfDNA targeted capture and ultra-high depth NGS sequencing (\>100,000×) to analyse the status of the surveillance loci in the peripheral blood for recurrence risk stratification and medication advice.
PFS
It is the time from local treatment of oligometastatic breast cancer to disease recurrence or death from any cause (whichever occurs first)
OS
It is the period from the date of randomisation until the date of the first confirmation of objective disease progression (as evaluated by the investigator in accordance with RECIST 1.1) or death from any cause (whichever occurs first)
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