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The investigators plan to carry out a phase II, open-label, single-arm clinical study of short-course trastuzumab, pertuzumab combined with taxanes in the adjuvant treatment of early HER2-positive breast cancer, to explore whether 4 courses of dual HER2 blockade combined with taxanes can lead to a similar prognosis with current standard treatment, which is one-year trastuzumab monotherapy combined with chemotherapy, while reducing the adverse reactions of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pertuzumab | Experimental | 4 cycles of taxane, Pertuzumab, Trastuzumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pertuzumab | Drug | 4 cycles of taxane, pertuzumab, trastuzumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival [DFS] | Time from surgery to first proven loco-regional recurrence, distant recurrence, second non-breast malignancy, or death from any cause | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival [OS] | Time from surgery to death from any cause | 3 year |
| Distant disease-free survival [DDFS] | Time from surgery to first proven distant recurrence, second non-breast malignancy, or death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaosong Chen | Contact | +8621-64370045*602102 | chenxiaosong0156@hotmail.com | |
| Yiwei Tong | Contact | +8621-64370045*602107 | ash_yiwei@sjtu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital | Recruiting | 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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| ID | Term |
|---|---|
| C485206 | pertuzumab |
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| 3 year |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 3 year |
| D017437 |
| Skin and Connective Tissue Diseases |