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.

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; MRD
• Intervention / Treatment: Diagnostic test: local treatment

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Zheng Lv; Phone Number: +8618844173475; Email: 826871727@qq.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Zheng Lv; Phone Number: 18844173475; Email: 826871727@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

1. Histologically or cytologically confirmed breast cancer.
2. Previously confirmed metastatic breast cancer by imaging.
3. 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:

1. Patients with active/refractory infections that require ongoing anti-infective therapy.
2. 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.
3. 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From enrollment to the end of treatment at 7 months

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: April 5, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Breast cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 24K013-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No