Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003012
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Following Surgery in Treating Women With Early Stage Breast Cancer
Sponsor:
Scottish Cancer Therapy Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Prospective Randomized Comparison of CMF Versus Sequential Epirubicin Followed by SMF as Adjuvant Chemotherapy for Women With Early Breast Cancer
Status:
COMPLETED
Status Verified Date:
2008-11
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known which combination chemotherapy regimen is more effective following surgery for breast cancer
PURPOSE Randomized phase III trial to study the effectiveness of combination chemotherapy consisting of cyclophosphamide methotrexate and fluorouracil with or without epirubicin in treating women who have early stage breast cancer
PURPOSE Randomized phase III trial to study the effectiveness of combination chemotherapy consisting of cyclophosphamide methotrexate and fluorouracil with or without epirubicin in treating women who have early stage breast cancer
Detailed Description:
OBJECTIVES I Compare the effects of 4 courses of epirubicin followed by 4 courses of cyclophosphamidemethotrexatefluorouracil CMF versus 8 courses of CMF as adjuvant chemotherapy in women with node positive early breast cancer as measured by overall and event free survival from the date or randomization II Compare the effects of 4 courses of epirubicin followed by 4 courses of CMF with 8 courses of CMF as adjuvant chemotherapy in these patients as measured by acute and chronic toxicities III Compare the effects of 4 courses of epirubicin followed by 4 courses of CMF versus 8 courses of CMF as adjuvant chemotherapy in these patients as measured by quality of life
OUTLINE This is a randomized multicenter study Patients are randomized into 2 treatment arms within 4 weeks of surgery Treatment begins within 6 weeks of surgery One treatment arm receives 8 courses of cyclophosphamidemethotrexatefluorouracil CMF given intravenously IV every 3 weeks The other arm receives 4 courses of epirubicin followed by 4 courses of CMF given IV every 3 weeks Patients are followed annually for 10 years
PROJECTED ACCRUAL A total of 1000 patients will be accrued over 3 years
OUTLINE This is a randomized multicenter study Patients are randomized into 2 treatment arms within 4 weeks of surgery Treatment begins within 6 weeks of surgery One treatment arm receives 8 courses of cyclophosphamidemethotrexatefluorouracil CMF given intravenously IV every 3 weeks The other arm receives 4 courses of epirubicin followed by 4 courses of CMF given IV every 3 weeks Patients are followed annually for 10 years
PROJECTED ACCRUAL A total of 1000 patients will be accrued over 3 years
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 |
|---|---|---|---|
| SCTN-BR9601 | None | None | None |
| EU-97013 | None | None | None |