RecruitingNCT06918262

Observational Clinical Study on Role of MRD in Predicting Local Therapy in Oligometastatic Breast Cancer

An Observational Clinical Study to Evaluate the Role of MRD in the Prediction of Local Therapy in Patients With Oligometastatic Breast Cancer.

Sponsor

The First Hospital of Jilin University

Enrollment

40 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Cancer MRD

Summary

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.

Eligibility

Inclusion Criteria5

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a written informed consent form and be willing and able to comply with all aspects of the trial protocol, which can be withdrawn by the patient at any time without prejudice.

Exclusion Criteria5

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.
\) Subjects with a prior malignancy other than breast cancer, cervical cancer in situ, and non-melanoma skin cancer, unless the prior malignancy has been previously diagnosed and definitively treated for at least 5 years without evidence of subsequent recurrence.
\) Any medical condition that, in the opinion of the Investigator, makes the subject unsuitable for entry into the study.

Interventions

DIAGNOSTIC_TESTlocal treatment

Tumour 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.