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Comparison of CNB and Surgical Specimens for ER, PgR, HER2 Status and Ki67 Index in Invasive Breast Cancer.

NCT02773784 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 314

Last updated 2019-01-18

No results posted yet for this study

Summary

* This is a prospective, single-center, non-randomized, non-controlled study.
* 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.

Conditions

Interventions

OTHER

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.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Zhao-Qing Fan, MD · Peking University Cancer Hospital & Institute

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-06-30
Completion
2016-09-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02773784 on ClinicalTrials.gov