Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-31 @ 10:19 PM
Study NCT ID:
NCT02108561
Status:
UNKNOWN
Last Update Posted:
2018-01-09
First Post:
2014-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breast Cancer Tumor Heterogeneity
Sponsor:
Anne Arundel Health System Research Institute
Organization:
Study Overview
Official Title:
Does Breast Tumor Heterogeneity Necessitate Additional HER2 Testing on the Surgical Specimens?
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Breast cancer biomarkers are usually performed on core needle biopsy (CNB) specimens and are not routinely repeated on surgical specimens (SS). However, preliminary data suggests that testing these biomarkers, on SS when compared to CNB samples can lead to different results. Our hypothesis is that The aim of this study is to identify a group of women with invasive breast cancer who may benefit from additional HER2 testing on their SS to ensure that areas of HER2 amplification are not missed. Another aim is to determine whether further HER2 testing on the SS in select patients would lead to changes in breast cancer treatment options.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: