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Patients with breast cancer meet criteria for enrollment are randomized into PTC group or control group. The neoadjuvant therapy regimens are guided by PTC test in the PTC group. The regimens in control group are included of (dd)EC-T for HER2 negative subtype, TCH(P) or EC-TH(P) for HER2 positive subtype. We compared the pCR rate between two groups as the primary endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTC group | Experimental | Patients randomized into this group receiving PTC test and choose regimens according to this test results |
|
| Control group | No Intervention | Patients randomized into this group receiving routine regimens according to subtypes |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patient-derived tumor-like cell clusters drug sensitivity test | Diagnostic Test | Intervention Description:Neoadjuvant therapy regimen of patients in the PTC group is guided by PTC drug sensitivity results. After operation, adjuvant targeted therapy for pCR patients is based on original treatment, adjuvant targeted therapy for non-pCR patients is based on a secondary PTC drug sensitivity results. |
| Measure | Description | Time Frame |
|---|---|---|
| pCR rate | pathological complete response | one month after operation |
| objective response rate | cCR or PR or SD according to RECIST1.1 | half year after randomize |
| Measure | Description | Time Frame |
|---|---|---|
| 2y-Disease free survival rate | survive with neither invasive recurrence nor new invasive diseases | 2year |
| 5y-Disease free survival rate | survive with neither invasive recurrence nor new invasive diseases |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xingfei Yu, M.D. | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001943 | Breast Neoplasms |
| D000095384 | Pathologic Complete Response |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
|
| 5year |
| D017437 |
| Skin and Connective Tissue Diseases |
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |