NCT02773784

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

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 314 (actual)
• Sponsor: Peking University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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

• Invasive Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-06-01
• Completion: 2016-09-01
• First posted: 2016-05-16
• Last updated: 2019-01-18

Locations

1 site across 1 country: China