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

Completed

• Conditions: Invasive Breast Cancer
• Interventions: Other: immunohistochemistry and/or FISH

• Registration Number: NCT02773784
• Lead Sponsor: Peking University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-09-16
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-16
• Primary Completion: 2016-06
• Study Completion: 2016-09
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 314

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
invasive breast cancer	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.

Primary Outcome Measures

Name	Time	Method
The accuracy of ER, PgR, Her-2 and Ki67 for core needle biopsy (CNB) using the surgical specimens as reference, respectively.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China