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

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ClinicalTrials.gov Identifier: NCT02773784
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Tao OUYANG, 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.

Condition or disease Intervention/treatment
Invasive Breast Cancer Other: immunohistochemistry and/or FISH

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Study Type : Observational
Actual Enrollment : 314 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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.
Actual Study Start Date : September 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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 :
  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 Outcome Measures :
  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 ]

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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
invasive breast cancer diagnosed by core needle biopsy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773784


Locations
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China, Beijing
Peking University Cancer Hospital
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Peking University
Investigators
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Principal Investigator: Zhao-Qing Fan, MD Beijing Cancer Hospital
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Responsible Party: Tao OUYANG, Director of Breast Center of Peking University Cancer Hospital, Peking University
ClinicalTrials.gov Identifier: NCT02773784    
Other Study ID Numbers: BCP16
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases