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Previous studies suggest that among patients receiving trastuzumab monotherapy, a HER2/CEP17 ratio >7.0 (ultra-high expression) is associated with poorer disease-free survival (DFS). Dual-target therapy (trastuzumab + pertuzumab) has become the standard treatment for high-risk HER2-positive breast cancer; however, whether it can predict outcomes in patients with ultra-high HER2 expression remains unsupported by clinical data. To analyze the clinicopathological characteristics and prognostic relationship between the HER2 ultra-high expression group and the normal expression group in non-metastatic HER2-positive breast cancer patients who received dual-target therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HER2 FISH ultra | HER2/CEP17 FISH ratio in HER2-positive non-metastatic breast cancer | ||
| HER2 FISH normal | HER2/CEP17 FISH ratio in HER2-positive non-metastatic breast cancer |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival based on HER2/CEP17 ratio | Defined as the period from the date of pathological diagnosis until the date of the first relapse, appearance of non-breast primary cancer, death with no signs or symptoms of recurrence or metast, or the last recorded follow-up ,whichever came first. | From the date of pathological diagnosis to event with follow-up duration ≥3 months (unless recurrence or death occurred within 3 month). |
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Inclusion Criteria:
Exclusion Criteria:
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HER2-positive patients with breast cancer were enrolled between January 2020 and December 2023.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fangchao Zheng, MD | Contact | 86-67627005 | sgzhfch@yeah.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Oncology | Recruiting | Jinan | Shandong | 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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| D017437 |
| Skin and Connective Tissue Diseases |