Comparison of CNB and Surgical Specimens for ER, PgR, HER2 Status and Ki67 Index in Invasive Breast Cancer.
NCT ID: NCT02773784
Last Updated: 2019-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
314 participants
OBSERVATIONAL
2014-09-30
2016-09-30
Brief Summary
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* The estrogen receptor (ER), progesterone receptor (PgR), HER2 status and Ki67 index of CNB specimen are critical biomarkers for making neoadjuvant therapy strategy in invasive breast cancer. The concordance of these biomarkers between CNB and surgical specimen was varied in previous retrospective reports. The aim of this study is to determine the discordance of these biomarkers between CNB and surgical specimen and the influence of making treatment strategy by the discordance.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
immunohistochemistry and/or FISH
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.
Interventions
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immunohistochemistry and/or FISH
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patient plans to receive neo-adjuvant system therapy
FEMALE
No
Sponsors
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Peking University
OTHER
Responsible Party
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Tao OUYANG
Director of Breast Center of Peking University Cancer Hospital
Principal Investigators
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Zhao-Qing Fan, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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BCP16
Identifier Type: -
Identifier Source: org_study_id
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