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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral blood sample collection | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Defined as the time from the diagnosis of the disease to the first occurrence of a death event from any cause | 5 years after surgery |
| Lead time | Defined as the time from the first positive peripheral blood MRD test to radiologically confirmed metastases |
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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:
ECOG 0-1
Willing to cooperate in clinical research-related treatment and follow-up, with good patient compliance
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Peripheral blood sample
| 2 years after surgery |
| D017437 |
| Skin and Connective Tissue Diseases |