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Optimizing Post-Surgery Adjuvant Treatments Using MRD Strategy in Early Stage Breast Cancer A Prospective Cohort Study
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2022-04-26
300
Participants Needed
3
Research Sites
156 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of minimal residual disease MRD testing to optimize post-surgery adjuvant therapies for early-stage breast cancer. This prospective, multi-center, open-label cohort study focuses on breast cancer patients classified into three groups triple-negative TNBC, HER2 positive HER2, and estrogen receptor positive ER. The main goal is to improve 3-year disease-free survival by adjusting treatments based on MRD status and clinical risk. The study assigns patients to treatment groups according to their cancer subtype, clinical risk, and MRD test results after surgery. Patients with high clinical risk or positive MRD receive more intensive adjuvant therapies, while those with low risk and negative MRD receive standard treatments. Treatment regimens are personalized and adjusted every three months depending on changes in MRD status. Examples include chemotherapy combined with targeted therapies or endocrine therapies, tailored to each subgroups needs. Participants will undergo MRD testing using personalized tumor-informed panels and receive standard guideline-based therapies. Follow-up occurs every three months to monitor MRD status and adjust treatment accordingly. Researchers will assess outcomes including 1-, 3-, and 5-year disease-free survival, overall survival, adverse events, and quality of life for up to five years. The study aims to provide detailed data on how MRD-guided therapy adjustments impact long-term patient outcomes after surgery.
CONDITIONS
Brief Title
Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer
Research Team
F
Fei Ma
H
Hongnan Mo
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