Ignite Creation Date:
2024-05-06 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03638648
Status:
UNKNOWN
Last Update Posted:
2019-09-10
First Post:
2018-08-16
Brief Title:
Recurrence Score-guiding Chemotherapy in Non-pCR HR Positive HER2 Negative Breast Cancer After Neoadjuvant Therapy
Sponsor:
Zhejiang Cancer Hospital
Organization:
Zhejiang Cancer Hospital
Study Overview
Official Title:
Multi Gene Detection Tool Based Recurrence Score-guiding Chemotherapy in Non-pathologic Complete Response HR Positive and HER2 Negative Breast Cancer After Neoadjuvant Treatment
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
NOT_YET_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:
RSBNAT
Brief Summary:
The luminal subtype of breast cancer means hormone receptor positive human epidermal growth factor receptor 2 negative HRHER2- which counted 60-70 of breast cancer but achieve low pathologic complete response pCR rate 75-15 in neoadjuvant chemotherapy It is controversial whether additional chemotherapy after surgery is necessary for those non-pCR HRHER2- patients Multiple gene is a mature diagnose tool for recurrence score in adjuvant treatment strategy This study is to investigating the value of multi gene detection tool based recurrence score for guiding additional chemotherapy after surgery in HRHER2- non-pCR breast cancer
Detailed Description:
This study is designed as stratified cluster randomized parallel-control research The HRHER2- breast cancer patients after neoadjuvant chemotherapy including anthracyclines and taxane at least 6 cycles assessed non-pCR are recruited receiving multiple gene test before neoadjuvant treatment and after surgery After enrollment the patients were stratified according to multiple gene test based recurrence risk level High risk or Low risk and then randomized into two groups respectively in each cluster receiving additional chemotherapy Capecitabine group or negative control group The primary endpoint is 2-year disease free survival The second endpoint is 5-year disease free survival DFS 2-year overall survival OS 5-year OS safety of additional chemotherapy The exploratory endpoint is the variety of multiple gene test based recurrence risk after neoadjuvant chemotherapy in non-pCR patients
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?:
False
Is an FDA AA801 Violation?:
None