MRD in High-risk EBC

Trial Title: MRD in High-risk EBC

NCT ID: NCT06566729

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
MRD
breast cancer
adjuvant therapy

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Prospective

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.

Criteria for eligibility:

Study pop:
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;

Sampling method: Probability Sample
Criteria:
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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: June 1, 2023

Completion date: April 2028

Lead sponsor:
Agency: Shanghai Jiao Tong University School of Medicine
Agency class: Other

Source: Shanghai Jiao Tong University School of Medicine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06566729