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Tracking Minimal Residual Disease Using Blood Tests to Detect Tumor DNA in Breast Cancer Patients Observing Different Treatment and Surveillance Groups to Predict Recurrence and Treatment Effectiveness

Led by Tempus AI · Updated on 2026-06-12

900

Participants Needed

14

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying breast cancer patients to find any remaining cancer cells, called minimal residual disease MRD, after their main treatment. Detecting these cells is important because even a small number can cause cancer to return later. This research looks at tiny pieces of cancer DNA in the blood, known as circulating tumor DNA ctDNA, to see if it can predict cancer recurrence and show if treatment is working. The study is observational and aims to help improve breast cancer management and develop better tests and treatments. Participants are grouped into three cohorts those receiving neoadjuvant therapy before surgery, those receiving adjuvant therapy after surgery, and those who have had no evidence of disease for at least five years after diagnosis. There are no interventions or treatments given as part of this study. Instead, the research involves regular blood tests to monitor ctDNA levels over time among these groups to understand cancer behavior and treatment effects. During the study, participants provide blood samples and biospecimens at several time points. Researchers track invasive disease-free survival and overall survival over five years, stratified by MRD status at different stages of treatment and follow-up. They also assess distant disease-free survival, pathologic complete response or residual cancer burden, and the time from first positive MRD detection to cancer recurrence. The study may last up to eight years, including long-term follow-up to monitor outcomes and better understand the role of ctDNA in breast cancer care.

CONDITIONS

Brief Title

Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies

Research Team

G

GEMINI Breast Clinical Study Manager

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