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

Peking University

Status: Completed

Conditions: Invasive Breast Cancer

Treatments: Other: immunohistochemistry and/or FISH

Study type: Observational

Funder types: Other

Identifiers

NCT02773784

BCP16

Details and patient eligibility

About

• 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.

Enrollment: 314 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

314 participants in 1 patient group

invasive breast cancer

Description:

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.

Treatment:

Other: immunohistochemistry and/or FISH