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Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and high risk of recurrence and metastasis. HER2 targeted drugs has greatly improved the prognosis and survival of such patients. At present, for HER2 positive breast cancer patients with negative lymph nodes, chemotherapy drugs combined with trastuzumab is the current standard treatment scheme, and in most cases, chemotherapy uses a combination of two drugs, while the main beneficiaries of the trastuzumab and paltuzumab are concentrated in the group of patients with positive lymph nodes. Can targeted therapy be used to reduce the progression of chemotherapy and further achieve efficient and low toxicity strategies. To explore the efficacy and safety of adjuvant therapy of taxane chemotherapy combined with trastuzumab targeting therapy for low-risk HER2 positive and lymph node negative early breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taxanes combined with trastuzumab | Taxane with trastuzumab. Taxane drugs allow the selection of paclitaxel, liposomal paclitaxel, albumin paclitaxel, or docetaxel. Chemotherapy is administered in a single week regimen with 12 cycles or a 3-week regimen with 4 cycles, with target therapy for 1 year |
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| Measure | Description | Time Frame |
|---|---|---|
| invasive disease free survival | The time from 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. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| disease free survival | The time from 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. | 5 years |
| distant disease free survival |
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Inclusion Criteria:
Exclusion Criteria:
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invasive breast cancer, and the pathological stage was T1a-b (T ≤ 1cm), N0, HER2 positive, with high-risk factors (G3, or hormone receptor negative); T1c (1cm < T ≤ 2cm), N0, and there are no high-risk factors (G1/G2, hormone receptor positive)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yuan peng, doctor | Contact | 86+13671287670 | 13671287670@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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The time from enrollment in the study to the occurrence of distant recurrence and metastasis. |
| 5 years |
| breast cancer specific survival | Time from enrollment to death due to breast cancer. Time from enrollment to death due to breast cancer. | 5 years |
| overall survival | The time from enrollment in the study to death caused by any reason | 5 years |