Ignite Creation Date:
2024-05-06 @ 2:15 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT02001519
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2012-07-05
Brief Title:
Additional 4 Cycles of Cisplatin CDDP4 in Patients With Triple Negative Breast Cancer for Neoadjuvant Chemotherapy
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
A Phase ll Trial of Impact of Additional 4 Cycles of Cisplatin CDDP4 in Patients With Triple Negative Breast Cancer Not Achieving Clinical CR After 4 Cycles of Neoadjuvant Adriamycin Plus Cyclophosphamide
Status:
COMPLETED
Status Verified Date:
2013-11
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:
PACER
Brief Summary:
Achievement of pathologic complete response is important prognosticator to predict long term outcome in triple negative cancer The efficacy of adding 4 cycles of cisplatin CDDP4 is to be investigated whether addtional pathologic complete response is achieved for those triple negative breast cancer patients who recieved 4 cycles of adriamycin with cyclophosphamideAC4 but did not reach clinical complete response during the course of neoadjuvant therapy
Detailed Description:
First outcome measures analysis at the time of surgery
Second outcome measures
2019 August 5 year Overall Survival Disease free survival
Second outcome measures
2019 August 5 year Overall Survival Disease free survival
Study Oversight
Has Oversight DMC:
None
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?:
None