Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-28 @ 2:06 AM
Study NCT ID:
NCT01834950
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2013-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Early Markers of Response and Resistance to Trastuzumab
Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Organization:
Study Overview
Official Title:
Identification of Early Markers of Response and Resistance to Trastuzumab in Patients With Localized Human Epidermal Growth Factor Receptor-2(HER-2)-Positive Breast Cancer Candidates for Breast Conserving Surgery
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
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:
HERBIN
Brief Summary:
The study is a single arm prospective study, aiming at identifying biomarkers of early response to trastuzumab. It is a prognostic factor study recruiting all consecutive cases of HER-2 positive breast cancer eligible for a pre-operative treatment by trastuzumab, followed by breast conserving surgery. The investigators will study the association between the value of biomarkers measured at diagnosis and the Response Evaluation Criteria in Solid Tumors response (partial and complete response) using a logistic regression (main analysis).
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012/1909 | OTHER | CSET number | View |