MRD in High-risk EBC

Active, not recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06566729
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2024-06
• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-21
• Last Update Submitted: 2024-08-21
• Study First Posted: 2024-08-22
• Last Update Posted: 2024-08-22
• Primary Completion: 2024-09-30
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 125

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse-free survival	5 years after surgery	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 Outcome Measures

Name	Time	Method
Overall survival	5 years after surgery	Defined as the time from the diagnosis of the disease to the first occurrence of a death event from any cause
Lead time	2 years after surgery	Defined as the time from the first positive peripheral blood MRD test to radiologically confirmed metastases