Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129935
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2005-08-11
Brief Title:
EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
Official Title:
Phase III Trial to Compare Epirubicin and Cyclophosphamide EC Followed by Docetaxel T to Epirubicin and Docetaxel ET Followed by Capecitabine X as Adjuvant Treatment Node Positive Breast Cancer Patients
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 prospective randomised phase III trial to compare the efficacy and safety profiles of two types of adjuvant chemotherapy regimens for human epidermal growth factor receptor 2 HER2 negative node positive breast cancer patients
Control Arm This includes 4 cycles of EC 90600 mgm2 day 1 every 3 weeks followed by 4 cycles of T 100 mgm2 day 1 every 3 weeks
Experimental Arm This includes 4 cycles of ET 9075 mgm2 day 1 every 3 weeks followed by 4 cycles of capecitabine 1250 mgm2 twice a day via oral intake for 14 days and then a one-week rest period
Premenopausal women with hormone receptor positive tumours must receive 5 years of tamoxifen after the end of chemotherapy
Postmenopausal women with hormone receptor positive tumours can receive tamoxifen or aromatase inhibitors or both after the end of chemotherapy
Patients may receive radiotherapy when clinically indicated
Control Arm This includes 4 cycles of EC 90600 mgm2 day 1 every 3 weeks followed by 4 cycles of T 100 mgm2 day 1 every 3 weeks
Experimental Arm This includes 4 cycles of ET 9075 mgm2 day 1 every 3 weeks followed by 4 cycles of capecitabine 1250 mgm2 twice a day via oral intake for 14 days and then a one-week rest period
Premenopausal women with hormone receptor positive tumours must receive 5 years of tamoxifen after the end of chemotherapy
Postmenopausal women with hormone receptor positive tumours can receive tamoxifen or aromatase inhibitors or both after the end of chemotherapy
Patients may receive radiotherapy when clinically indicated
Detailed Description:
Estimation of the 5-year disease-free survival in the control arm is 72 The experimental arm is expected to increase the 5-year disease-free survival by 7 up to 79 With an alpha error of 005 and 80 power 592 patients per arm are needed Assuming a 17 post-randomization drop-out 691 patients per arm are needed
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