Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128856
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2005-08-09
Brief Title:
Gemcitabine Doxorubicin and Paclitaxel GAT as Neoadjuvant Treatment of Breast Cancer Patients
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
Official Title:
Phase II Pharmacogenomic and Clinical Trial for the Administration of Gemcitabine-doxorubicin-paclitaxel GAT as Neoadjuvant Treatment of Patients With Stage III Breast Cancer
Status:
COMPLETED
Status Verified Date:
2023-03
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 is a multicenter open-label phase II trial to assess the efficacy of the GAT neoadjuvant regimen in patients with stage III breast cancer
Detailed Description:
2 treatment cycles of chemotherapy one cycle 2 weeks must be administered to each patient before breast surgery
The required number of patients has been calculated following Simons method 43 patients will be enrolled in two phases first 29 patients must be enrolled and at least 2 pathological complete responses obtained Patients recruitment will continue until 43 patients have been enrolled Assumptions are that there is a 95 probability to obtain a rate of pathological complete responses of at least 10
The required number of patients has been calculated following Simons method 43 patients will be enrolled in two phases first 29 patients must be enrolled and at least 2 pathological complete responses obtained Patients recruitment will continue until 43 patients have been enrolled Assumptions are that there is a 95 probability to obtain a rate of pathological complete responses of at least 10
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