Status:
ACTIVE_NOT_RECRUITING
MRD in High-risk EBC
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
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 specime...
Eligibility Criteria
Inclusion
- 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:
- Hormone receptor-positive/HER2-negative breast cancer, the number of lymph node metastases ≥ 4;
- HER2-positive breast cancer, lymph node metastasis≥4;
- 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
- 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
Key Trial Info
Start Date :
June 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06566729
Start Date
June 1 2023
End Date
April 1 2028
Last Update
August 22 2024
Active Locations (1)
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1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025