Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129376
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2005-08-10
Brief Title:
Doxorubicin and Cyclophosphamide AC Followed by Weekly Docetaxel as Neoadjuvant Treatment of Breast Cancer Patients
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
Official Title:
Multicenter Phase II Trial of Doxorubicin and Cyclophosphamide AC Followed by Weekly Docetaxel T as Neoadjuvant Treatment for Operable Stage II and IIIA Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2019-04
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:
Treatment consists of 4 AC cycles followed by 2 weekly docetaxel cycles 12 infusions
The pathological complete response rate obtained in previous studies is around 12 The expected pathological complete response rate in this study is 25 With an alpha error of 005 and a beta error of 02 and following Simons 2 phase test 19 patients are needed initially With 2 pathological complete responses patient recruitment will continue until approximately 61 patients are recruited Twelve pathological complete responses are needed to confirm the study hypothesis
The pathological complete response rate obtained in previous studies is around 12 The expected pathological complete response rate in this study is 25 With an alpha error of 005 and a beta error of 02 and following Simons 2 phase test 19 patients are needed initially With 2 pathological complete responses patient recruitment will continue until approximately 61 patients are recruited Twelve pathological complete responses are needed to confirm the study hypothesis
Detailed Description:
Patients received doxorubicin 60 mgm2 and cyclophosphamide 600 mgm2 both in a short intravenous infusion every three weeks for four cycles days 1 22 43 and 64 Three weeks later docetaxel 36 mgm2 was administered as a 30-min intravenous infusion weekly for six weeks days 85 92 99 106 113 and 120 followed by a 2-week resting period 8-week cycle After that patients received a second docetaxel cycle infusions on days 141 148 155 162 169 and 176 Adjuvant chemotherapy and radiotherapy were delivered according to the protocol of each participating center Hormonal treatment was started after the last chemotherapy infusion in all patients with positive estrogen andor progesterone receptor tumors and was continued for five years
Semiquantitative determination of three molecular markers was carried out by immunocytochemical methods Tissue samples were taken prior to initiation of chemotherapy from the core of the primary tumors Specimens were sent to a central laboratory for analysis of Topo II survivin and p27
Semiquantitative determination of three molecular markers was carried out by immunocytochemical methods Tissue samples were taken prior to initiation of chemotherapy from the core of the primary tumors Specimens were sent to a central laboratory for analysis of Topo II survivin and p27
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