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

NCT06918262 | Recruiting DMC

• 1 other identifier: 24K013-001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; MRD

Keywords

Breast cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  It is the time from local treatment of oligometastatic breast cancer to disease recurrence or death from any cause (whichever occurs first)

  From enrollment to the end of treatment at 7 months

Secondary Outcomes (1)

• OS

  From enrollment to the end of treatment at 7 months

Interventions

local treatment DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Zheng Lv

CONTACT

+8618844173475; 826871727@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 9, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)