Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05837455
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-04-18
Brief Title:
NeoTAILOR ABiomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage IIIII ER-positive HER2-negative Breast Cancer
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
NeoTAILOR A Phase II Biomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage IIIII ER-positive HER2-negative Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
This study aims to utilize a novel biomarker-driven approach to guide neoadjuvant treatment selection It is the hypothesis that this will improve clinical response for postmenopausal women with clinical stage IIIII ER-positive HER2-negative breast cancer and identify those who may not require neoadjuvant chemotherapy with a primary focus on outcomes in Black patients
Detailed Description:
Risk category is defined as follows
Low risk
Baseline Ki67 10 OR
Luminal A molecular intrinsic subtype by PAM50
High risk
Non-Luminal A molecular intrinsic subtype by PAM50 OR
In cases of non-diagnostic PAM50 molecular intrinsic subtype patients will enroll in the high-risk group and undergo Week 4 tumor biopsy
Low risk
Baseline Ki67 10 OR
Luminal A molecular intrinsic subtype by PAM50
High risk
Non-Luminal A molecular intrinsic subtype by PAM50 OR
In cases of non-diagnostic PAM50 molecular intrinsic subtype patients will enroll in the high-risk group and undergo Week 4 tumor biopsy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None