Observing MRD's role in local treatment for 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 study is trying to see if measuring minimal residual disease (MRD) can help doctors figure out which patients with oligometastatic breast cancer will do better after local treatment.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Sex: All
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT06918262 on ClinicalTrials.gov

What this trial studies

This observational study investigates the correlation between minimal residual disease (MRD) levels and prognosis in patients with oligometastatic breast cancer who have undergone local treatment. Participants will provide medical history and demographic information, undergo imaging and MRD testing prior to treatment, and continue with assessments every three months throughout the study. The goal is to identify which patients may benefit from localized treatment based on their MRD levels and to develop individualized treatment plans.

Who should consider this trial

Good fit: Ideal candidates include women aged 18 and older with histologically confirmed breast cancer and no more than five systemic metastases.

Not a fit: Patients with active infections requiring treatment or severe cardiovascular issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help tailor local treatment strategies for patients with oligometastatic breast cancer, potentially improving their outcomes.

How similar studies have performed: While there have been studies on MRD in other cancers, this specific approach in oligometastatic breast cancer is relatively novel.

Eligibility criteria

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.

Where this trial is running

Changchun, Jilin

• The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Study coordinator: Zheng Lv

Conditions Breast Cancer; MRD; Breast cancer