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

January 16, 2019 updated by: Tao OUYANG, Peking University

Comparison of Core Needle Biopsy (CNB) and Surgical Specimens for Estrogen Receptor (ER), Progesterone Receptor (PgR), Human Epidermal Growth Factor Receptor 2 (HER2) Status and Ki67 Index in Invasive Breast Cancer.

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

314

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Peking University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

invasive breast cancer diagnosed by core needle biopsy

Description

Inclusion Criteria:

  • • histologically confirmed primary invasive breast cancer by core needle biopsy

Exclusion Criteria:

  • • pathological diagnosed ductal carcinoma in situ or microinvasive breast cancer by core needle biopsy

    • patient plans to receive neo-adjuvant system therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: within 4 weeks after obtaining the post-surgery pathological results
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

Secondary Outcome Measures

Outcome Measure
Time Frame
Discordance of system therapy strategies between using biomarkers of CNB and surgical specimens.
Time Frame: within 4 weeks after obtaining the post-surgery pathological results
within 4 weeks after obtaining the post-surgery pathological results

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Investigators

  • Principal Investigator: Zhao-Qing Fan, MD, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2014

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

September 16, 2015

First Submitted That Met QC Criteria

May 11, 2016

First Posted (ESTIMATE)

May 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2019

Last Update Submitted That Met QC Criteria

January 16, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCP16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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