Clinical trial · Observational
MRD in High-risk EBC
Application of Molecular Residual Disease in the Recurrence Monitoring and Response Predicting of High-risk Early Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a multicenter, prospective, observational cohort study, 125 patients with early-stage high-risk breast cancer will be enrolled, perioperative surgical specimens, peripheral blood specimens before and after adjuvant therapy and follow-up will be collected, and the predictive effect of MRD of molecular residual lesions on recurrence events and drug efficacy will be evaluated through dynamic monitoring, so as to further accurately stratify the risk and guide clinical intervention.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peripheral blood sample collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Relapse-free survival
- timeFrame
- 5 years after surgery
- description
- Defined as the time from the diagnosis of the disease to the first occurrence of a local recurrence of breast cancer, distant recurrence, or death from any cause
Secondary outcomes (2)
- measure
- Overall survival
- timeFrame
- 5 years after surgery
- description
- Defined as the time from the diagnosis of the disease to the first occurrence of a death event from any cause
- measure
- Lead time
- timeFrame
- 2 years after surgery
- description
- Defined as the time from the first positive peripheral blood MRD test to radiologically confirmed metastases
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent signed * Age ≥18 years old * Undergoing breast surgery, the surgical specimen was diagnosed as invasive breast cancer by the central laboratory and met any of the following conditions: 1. Hormone receptor-positive/HER2-negative breast cancer, the number of lymph node metastases ≥ 4; 2. HER2-positive breast cancer, lymph node metastasis≥4; 3. Triple negative breast cancer, the number of lymph node metastases ≥ 1; * ECOG 0-1 * Willing to cooperate in clinical research-related treatment and follow-up, with good patient compliance Exclusion Criteria: * Confirmed distant metastases site * History of other malignancy * Psychopaths or other reasons unable to comply with treatment * Concomitant uncontrolled lung disease, severe liver and kidney disease, severe infection, active peptic ulcer requiring treatment, coagulation disorders, connective tissue disease, or bone marrow suppression, and cannot tolerate chemotherapy and other related treatments * HIV carrier or HBC/HCV infected * Current or recent (within 30 days prior to enrollment) use of participation in another investigational program or use of another investigational drug
References
Publications (0)
Data not yet available