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NCT Number: NCT02773784

Comparison of CNB and Surgical Specimens for ER, PgR, 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.

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Key information

Conditions

Invasive Breast Cancer

Sex eligibility

Female

Study type

Observational

Primary location

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

immunohistochemistry and/or FISH

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

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.

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 16, 2016
Registry last updated
Jan 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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