An observational study in Breast Cancer and MRD, sponsored by The First Hospital of Jilin University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by The First Hospital of Jilin University · Observational
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.
This is an observational study to investigate the correlation between MRD levels and prognosis in patients with locally treated oligometastases of breast cancer, who have no more than 5 systemic metastases of breast cancer, which may not be confined to the same organ (with the exception of brain metastases), and who have stable systemic control of the disease, and who are to undergo localised treatment. Subjects will read and fully consider the \"Informed Consent Form\" for this study, sign it in writing if they decide to participate in the study, and complete the Screening Visit no later than 28 days prior to the start of study treatment. For ethical reasons, the screening visit may not be repeated if it was performed prior to the signing of the Informed Consent Form. Subjects were asked to complete imaging and MRD testing prior to their first study treatment, and to undergo on-tumour imaging and MRD testing every 3 months (±7 days) for the duration of the study, and additional investigations or more frequent on-tumour imaging evaluations could be performed during the study based on clinical indications. During this period, subjects continued study treatment until disease progression occurred, toxicity was intolerable, the subject voluntarily withdrew informed consent, or the investigator determined that the subject needed to withdraw from the study. Subjects with disease progression or early withdrawal were also required to complete an exit visit and then enter safety follow-up.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 40 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →The First Hospital of Jilin University is the lead sponsor of 181 studies on the registry; 93 are open to participants now.
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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.
(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 Criteria:
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.
PFS
It is the time from local treatment of oligometastatic breast cancer to disease recurrence or death from any cause (whichever occurs first)
Time frame: From enrollment to the end of treatment at 7 months
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)
Time frame: From enrollment to the end of treatment at 7 months
Plan to share: No
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The First Hospital of Jilin University