MRD in High-risk EBC

N/AActive Not RecruitingNCT06566729

Shanghai Jiao Tong University School of Medicine125 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

125

Conditions

Breast Cancer

Interventions

Peripheral blood sample collectionOTHER

In this study, peripheral blood samples would be collected before adjuvant chemotherapy, after adjuvant chemotherapy and every 3 months thereafter until 2 years after surgery.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Relapse-free survival

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

Time frame: 5 years after surgery

Secondary Outcomes

Overall survival

Defined as the time from the diagnosis of the disease to the first occurrence of a death event from any cause

Time frame: 5 years after surgery

Lead time

Defined as the time from the first positive peripheral blood MRD test to radiologically confirmed metastases

Time frame: 2 years after surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.