Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022516
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2001-08-10
Brief Title:
Low-dose Oral Cyclophosphamide and Methotrexate Maintenance for Hormone Receptor-negative Early Breast Cancer
Sponsor:
ETOP IBCSG Partners Foundation
Organization:
ETOP IBCSG Partners Foundation
Study Overview
Official Title:
Low-dose Cytotoxics as Anti-angiogenesis Treatment Following Adjuvant Induction Chemotherapy for Patients With ER-negative and PgR-negative Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-08
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:
22-00
Brief Summary:
This randomized phase III trial was designed to test the efficacy of a low-dose chemotherapy-maintenance regimen hypothesized to have anti-angiogenic activity administered following standard chemotherapy in patients with early breast cancer whose tumors are hormone receptor negative
Detailed Description:
PURPOSE
Evaluate a low-dose cyclophosphamide and methotrexate chemotherapy-maintenance regimen in early breast cancer
Compare the disease-free survival overall survival and systemic disease-free survival of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
OUTLINE
This is a randomized open-label multicenter study Patients are stratified according to participating center menopausal status pre vs post and approved induction chemotherapy anthracycline and cyclophosphamide vs other agents Treatment duration is 12 months of low-dose chemotherapy-maintenance regimen CM-maintenance vs no chemotherapy-maintenance regimen no-CM following standard adjuvant chemotherapy Patients are randomized to one of two treatment arms Patients are followed every 6 months for 5 years and yearly follow-up thereafter
Evaluate a low-dose cyclophosphamide and methotrexate chemotherapy-maintenance regimen in early breast cancer
Compare the disease-free survival overall survival and systemic disease-free survival of patients treated with these regimens
Compare the toxic effects of these regimens in these patients
OUTLINE
This is a randomized open-label multicenter study Patients are stratified according to participating center menopausal status pre vs post and approved induction chemotherapy anthracycline and cyclophosphamide vs other agents Treatment duration is 12 months of low-dose chemotherapy-maintenance regimen CM-maintenance vs no chemotherapy-maintenance regimen no-CM following standard adjuvant chemotherapy Patients are randomized to one of two treatment arms Patients are followed every 6 months for 5 years and yearly follow-up thereafter
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 |
|---|---|---|---|
| EU-20119 | REGISTRY | NCI Liaison Office Brussels | None |
| IBCSG-22-00 | OTHER | None | None |
| 2005-005666-36 | EUDRACT_NUMBER | None | None |