Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-27 @ 10:13 PM
Study NCT ID:
NCT01622361
Status:
UNKNOWN
Last Update Posted:
2013-09-30
First Post:
2012-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer
Sponsor:
Asan Medical Center
Organization:
Study Overview
Official Title:
A Phase III, Open-Label, Prospective, Randomized, Multicenter, Neo-adjuvant Study of Chemotherapy Versus Endocrine Therapy in Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2013-09
Last Known Status:
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:
NEST
Brief Summary:
The purpose of this study is to compare neo-adjuvant therapy of cytotoxic chemotherapy versus GnRHa with tamoxifen , of response rate(RR) in patients of hormone responsive and HER2 negative, lymph node positive, primary breast cancer in premenopausal women.
Detailed Description:
1. Primary objective
: Response Rate-MRI and/or Caliper
2. Secondary objectives
* Pathologic complete response
* Rate of conservation surgery
* Ki-67 changes and its relationship to treatment response
* Length of time to maximum response within the treatment period
* Tolerability of two treatments
* Disease-free survival(DFS)
* Overall survival
: Response Rate-MRI and/or Caliper
2. Secondary objectives
* Pathologic complete response
* Rate of conservation surgery
* Ki-67 changes and its relationship to treatment response
* Length of time to maximum response within the treatment period
* Tolerability of two treatments
* Disease-free survival(DFS)
* Overall survival
Study Oversight
Has Oversight DMC:
True
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?: