Ignite Creation Date:
2024-05-06 @ 10:36 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03304756
Status:
COMPLETED
Last Update Posted:
2017-10-25
First Post:
2017-08-11
Brief Title:
Study of Neoadjuvant Treatment of Locally Advanced Breast Cancer With CAP Regimen
Sponsor:
Instituto Nacional de Cancer Brazil
Organization:
Instituto Nacional de Cancer Brazil
Study Overview
Official Title:
Phase II Study of Neoadjuvant Treatment of Locally Advanced Breast Cancer Patients With the CAP Regimen
Status:
COMPLETED
Status Verified Date:
2017-10
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:
CAPneo
Brief Summary:
This is a single arm single center non-randomized phase II trial of stage IIBIII TNBC Patients received neoadjuvant chemotherapy with cisplatin 50 mgm2 in combination with doxorubicin 50 mgm2 and cyclophosphamide 500 mgm2 every 21 days and for a total of 6 cycles After surgery adjuvant chemotherapy consisting of docetaxel 75 mgm2 every 21 days was further provided for 4 cycles Primary outcome was pathological complete response in the breast and axilla pCR ypT0ypN0 Secondary outcomes were safety disease-free survival and overall survival
Detailed Description:
This is a non-randomized open-label single arm single center phase II clinical trial Patients received neoadjuvant chemotherapy with cisplatin 50 mgm2 intravenous IV day 1 in combination with doxorubicin 50 mgm2 IV day 1 and cyclophosphamide 500 mgm2 IV day 1 every 21 days and for a total of 6 cycles CAP regimen Subsequent mastectomy plus axillary lymph node dissection was performed Pathological specimen was analyzed to assess tumor response in the breast and axilla Adjuvant chemotherapy consisting of docetaxel 75 mgm2 IV every 21 days was further provided for 4 cycles In case of tumor progression during neoadjuvant treatment CAP was discontinued and additional local or systemic treatment was provided at the discretion of the investigator The protocol was approved by the institutional review board of National Cancer Institute - Brazil All patients provided written informed consent The Brazilian Group of Breast Cancer Studies GBECAM and National Cancer Institute -Brazil were the academic sponsors and National Cancer Institute- Brazil was the funding source of the trial
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