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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Diagnostic test local 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

Primary outcome measures

• PFS [Time frame: From enrollment to the end of treatment at 7 months]

Secondary outcome measures (1)

• OS [Time frame: From enrollment to the end of treatment at 7 months]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

5\) 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.

6\) Any medical condition that, in the opinion of the Investigator, makes the subject unsuitable for entry into the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

China · 1 center

• The First Hospital of Jilin University — Changchun

Identifiers

NCT: NCT06918262 · 24K013-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗