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

NCT02773784 | Completed

• 1 other identifier: BCP16
• Study Type: observational
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Invasive Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• Discordance of system therapy strategies between using biomarkers of CNB and surgical specimens.

  within 4 weeks after obtaining the post-surgery pathological results

Study Arms (1)

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

Interventions

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.

invasive breast cancer

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

invasive breast cancer diagnosed by core needle biopsy

You may qualify if:

• histologically confirmed primary invasive breast cancer by core needle biopsy

You may not qualify if:

• pathological diagnosed ductal carcinoma in situ or microinvasive breast cancer by core needle biopsy
• patient plans to receive neo-adjuvant system therapy

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

ER, PgR, 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.

Study Officials

• Zhao-Qing Fan, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Breast Center of Peking University Cancer Hospital

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: May 16, 2016
• Study Start: September 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 18, 2019

Record last verified: 2019-01

Locations

CN (1)