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This study is a multicenter, retrospective, real-world cohort study. It retrospectively collected data from HER2-positive breast cancer patients who received neoadjuvant therapy with trastuzumab-containing chemotherapy regimens and had Non-pCR after surgery between July 2019 and July 2025. Patients were divided into two groups based on their adjuvant treatment regimens: the trastuzumab combined with pertuzumab group (HP) and the ado-trastuzumab emtansine group (T-DM1). The planned sample size is 2000 cases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HP | The trastuzumab combined with pertuzumab group | ||
| T-DM1 | The ado-trastuzumab emtansine group |
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| Measure | Description | Time Frame |
|---|---|---|
| Three-year invasive disease-free survival (iDFS) rate for non-pCR patients | iDFS events include local and regional recurrence, distant metastasis, contralateral invasive breast cancer, second non-breast primary cancer (excluding non-invasive carcinoma in situ), and death from any cause at 3 years. | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year iDFS rate in Near-pCR patients: | 3-year iDFS rate in Near-pCR patients: iDFS events include local and regional recurrence, distant metastasis, contralateral invasive breast cancer, second non-breast primary cancer (excluding non-invasive carcinoma in situ), and death from any cause at 3 years in Near-pCR patients (Near-pCR is defined as Miller & Payne grade 4, MP5 with invasive cancer present in axillary lymph nodes, RCB1). |
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Inclusion Criteria:
Exclusion Criteria:
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The planned total number of cases is 2000.
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| From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years. |
| Overall survival | Overall Survival (OS) refers to the length of time from either the date of diagnosis or the start of treatment for a disease (such as cancer) until death from any cause. | It is a direct measure of the treatment's ultimate impact on patient survival. |
| Adverse Events | Safety refers to the assessment of adverse events (AEs) and potential risks associated with a medical intervention (e.g., drug, device, procedure) | From date of enrollment until adjuvant therapy after surgery 1 year |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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