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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| invasive breast cancer | Patients with invasive breast cancer diagnosed by core needle biopsy (CNB) and not to receive neoadjuvant system therapy are eligible for this study. ER, PR, Her-2 and Ki67 are determined by immunohistochemistry (IHC) in CNB and surgical specimen. FISH analysis will be carried out in all HER2 2+ samples. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immunohistochemistry and/or FISH | Other | Patients with invasive breast cancer diagnosed by core needle biopsy (CNB) and not to receive neoadjuvant system therapy are eligible for this study. ER, PR, Her-2 and Ki67 are determined by immunohistochemistry (IHC) in CNB and surgical specimen. FISH analysis will be carried out in all HER2 2+ samples. |
| Measure | Description | Time Frame |
|---|---|---|
| The accuracy of ER, PgR, Her-2 and Ki67 for core needle biopsy (CNB) using the surgical specimens as reference, respectively. | The accuracy of ER, PgR, Her-2 and Ki67 for core needle biopsy (CNB) will be assessed by four parameters respectively, which are sensitivity, specificity, the negative predictive values and the positive predictive values, using the surgical specimens as reference. | within 4 weeks after obtaining the post-surgery pathological results |
| Measure | Description | Time Frame |
|---|---|---|
| Discordance of system therapy strategies between using biomarkers of CNB and surgical specimens. | within 4 weeks after obtaining the post-surgery pathological results |
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Inclusion Criteria:
Exclusion Criteria:
• pathological diagnosed ductal carcinoma in situ or microinvasive breast cancer by core needle biopsy
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invasive breast cancer diagnosed by core needle biopsy
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| Name | Affiliation | Role |
|---|---|---|
| Zhao-Qing Fan, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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ER, PgR, Her-2 and Ki67 are determined by immunohistochemistry (IHC) in CNB and surgical specimen. FISH analysis will be carried out in all HER2 2+ samples.
|