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Chemotherapy combined with trastuzumab and patuzumab is the standard neoadjuvant therapy for HER2 positive breast cancer patients. The survival rate of patients with pathological complete response (PCR) after neoadjuvant therapy was significantly better than that of patients with tumor residue, that is, non-PCR. Therefore, studies have confirmed that adjuvant therapy for patients with non-PCR after neoadjuvant chemotherapy can further improve the prognosis and survival of this population. However, the results of previous studies are based on trastuzumab target therapy in neoadjuvant therapy. Therefore, there are different recommendations for the current guidelines of adjuvant therapy after trastuzumab combined pertuzumab target neoadjuvant therapy. Patients with HER2 positive breast cancer who received trastuzumab and patuzumab based neoadjuvant therapy had invasive residual cancer in postoperative pathology. The effect of postoperative adjuvant therapy with trastuzumab and patuzumab or replacement of T-DM1 on survival.
Investigators retrospectively recruited patients with HER2 positive breast cancer who received trastuzumab and patuzumab based neoadjuvant therapy had invasive residual cancer in postoperative pathology from January 1, 2019 to November 31, 2024, and prospectively recruit patients of the same type from December 1, 2024 to December 31, 2028.
Inclusion Criteria:
Exclusion Criteria:
The therapy choice Arm 1: The postoperative adjuvant regimen is a combination of trastuzumab and pertuzumab, with a planned treatment duration of 1 year; Arm 2: Postoperative adjuvant therapy was T-DM1, with a planned treatment duration of 1 year.
Primary end point 3-years invasive disease free survival
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab combined with pertuzumab | The postoperative adjuvant regimen was trastuzumab combined with pertuzumab, and the planned treatment duration was 1 year | ||
| T-DM1 | The postoperative adjuvant regimen was T-DM1, and the planned treatment duration was 1 year |
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| Measure | Description | Time Frame |
|---|---|---|
| invasive disease free survival | Time from study enrollment to the first occurrence of the following events defined as failure: local recurrence of ipsilateral invasive breast cancer, contralateral invasive breast cancer, distant recurrence or death from any cause | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| disease free survival | Time from study enrollment to the first occurrence of the following events defined as failure, including ipsilateral local recurrence, contralateral breast cancer, distant recurrence or death from any cause | 3 years |
| distant disease free survival |
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Inclusion Criteria:
Exclusion Criteria:
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HER2 positive breast cancer patients with residual invasive breast cancer after neoadjuvant chemotherapy combined with trastuzumab and pertuzumab
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yuan peng, doctor | Contact | 86+13671287670 | 13671287670@163.com |
| Name | Affiliation | Role |
|---|---|---|
| shu wang, doctor | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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Tumor paraffin sample for each patient
Time from study enrollment to distant recurrence and metastasis |
| 3 years |
| breast cancer specific survival | Time from study enrollment to death due to breast cancer | 3 years |
| overall survival | Time from study enrollment to death from any cause | 3 years |