Ignite Creation Date:
2024-07-17 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498154
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-06
Brief Title:
Eliminating Breast Surgery for Breast Cancer Patients With Clinical Complete Response to Neoadjuvant Systemic Therapy
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
Eliminating Breast Surgery for Triple Negative or HR-HER2 Breast Cancer Patients With Clinical Complete Response to Combined Neoadjuvant Chemotherapy and Neoadjuvant Radiotherapy A Multicenter Phase 2 Trial EBCS
Status:
NOT_YET_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:
Phase II multicenter prospective study on the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant radiotherapy and neoadjuvant chemotherapy
Detailed Description:
The main purpose To explore the safety of eliminating surgery for triple negative or HER2 positive breast cancer patients with clinical response to neoadjuvant chemoradiotherapy Secondary study objective To explore predictive molecular biomarkers of response to neoadjuvant chemoradiotherapy and investigate whether ctDNA can predict pCR or survival outcome
Primary endpoint 5-year event-free survival 5-year EFS Secondary end points Whether combined neoadjuvant chemoradiotherapy can improve breast pathological complete response rate bpCR ypT0 overall survival OS patient-reported outcomes PROs and safety
Primary endpoint 5-year event-free survival 5-year EFS Secondary end points Whether combined neoadjuvant chemoradiotherapy can improve breast pathological complete response rate bpCR ypT0 overall survival OS patient-reported outcomes PROs and safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None