MedPath

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

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
Female
Target Recruitment
125
Inclusion Criteria

Inclusion Criteria:<br><br> - Informed consent signed<br><br> - Age =18 years old<br><br> - Undergoing breast surgery, the surgical specimen was diagnosed as invasive breast<br> cancer by the central laboratory and met any of the following conditions:<br><br> 1. Hormone receptor-positive/HER2-negative breast cancer, the number of lymph node<br> metastases = 4;<br><br> 2. HER2-positive breast cancer, lymph node metastasis=4;<br><br> 3. Triple negative breast cancer, the number of lymph node metastases = 1;<br><br> - ECOG 0-1<br><br> - Willing to cooperate in clinical research-related treatment and follow-up, with good<br> patient compliance<br><br>Exclusion Criteria:<br><br> - Confirmed distant metastases site<br><br> - History of other malignancy<br><br> - Psychopaths or other reasons unable to comply with treatment<br><br> - Concomitant uncontrolled lung disease, severe liver and kidney disease, severe<br> infection, active peptic ulcer requiring treatment, coagulation disorders,<br> connective tissue disease, or bone marrow suppression, and cannot tolerate<br> chemotherapy and other related treatments<br><br> - HIV carrier or HBC/HCV infected<br><br> - Current or recent (within 30 days prior to enrollment) use of participation in<br> another investigational program or use of another investigational drug

Exclusion Criteria

Not provided

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Relapse-free survival
Secondary Outcome Measures
NameTimeMethod
Overall survival;Lead time
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