Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129389
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2005-08-10
Brief Title:
FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
Official Title:
Multicenter Randomized Phase III Trial to Compare 6 FAC Cycles vs 4 FAC Cycles Followed by 8 Weekly Paclitaxel Administrations as Adjuvant Treatment for Node Negative Operable 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 open-label randomized phase III trial Patients will be stratified after breast surgery as per investigational site menopausal status node negative diagnosis as per sentinel-node technique versus lymphadenectomy hormone receptor status positive versus negative
Detailed Description:
Patients will be randomized to
Fluorouracil doxorubicin and cyclophosphamide FAC x 6 cycles 5-fluorouracil 500 mgm2 doxorubicin 50 mgm2 cyclophosphamide 500 mgm2 day 1 every 3 weeks for 6 cycles
FAC x 4 cycles Paclitaxel x 8 cycles 5-fluorouracil 500 mgm2 doxorubicin 50 mgm2 cyclophosphamide 500 mgm2 day 1 every 3 weeks for 4 cycles followed by 8 administrations of weekly paclitaxel 100 mgm2
Premenopausal women with hormone receptor positive tumors must receive tamoxifen 20 mg daily for 5 years after the end of chemotherapy
Postmenopausal women with hormone receptor positive tumors are allowed to receive aromatase inhibitors as initial adjuvant hormone therapy or after tamoxifen
All patients with breast conservative surgery must receive radiotherapy
Estimated 5-year disease-free survival in the control arm FAC x 6 is expected to be 80 It is expected that disease-free survival will increase by 5 in the experimental arm FAC-paclitaxel 906 patients per arm must be recruited to detect this difference with an alpha error of 005 and 80 power Assuming a 6 post-randomization drop-out rate 960 patients per arm are needed 1920 in total
Fluorouracil doxorubicin and cyclophosphamide FAC x 6 cycles 5-fluorouracil 500 mgm2 doxorubicin 50 mgm2 cyclophosphamide 500 mgm2 day 1 every 3 weeks for 6 cycles
FAC x 4 cycles Paclitaxel x 8 cycles 5-fluorouracil 500 mgm2 doxorubicin 50 mgm2 cyclophosphamide 500 mgm2 day 1 every 3 weeks for 4 cycles followed by 8 administrations of weekly paclitaxel 100 mgm2
Premenopausal women with hormone receptor positive tumors must receive tamoxifen 20 mg daily for 5 years after the end of chemotherapy
Postmenopausal women with hormone receptor positive tumors are allowed to receive aromatase inhibitors as initial adjuvant hormone therapy or after tamoxifen
All patients with breast conservative surgery must receive radiotherapy
Estimated 5-year disease-free survival in the control arm FAC x 6 is expected to be 80 It is expected that disease-free survival will increase by 5 in the experimental arm FAC-paclitaxel 906 patients per arm must be recruited to detect this difference with an alpha error of 005 and 80 power Assuming a 6 post-randomization drop-out rate 960 patients per arm are needed 1920 in total
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-003109-10 | EUDRACT_NUMBER | None | None |