Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003577
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer
Sponsor:
University Hospital Birmingham
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
National Breast Cancer Study of Epirubicin CMF v Classical CMF Adjuvant Therapy
Status:
COMPLETED
Status Verified Date:
2001-02
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 Combining more than one drug may kill more tumor cells It is not yet known whether combination chemotherapy plus epirubicin is more effective than combination chemotherapy alone for stage I or stage II breast cancer
PURPOSE This randomized phase III trial is studying combination chemotherapy alone to see how well it works compared to combination chemotherapy and epirubicin in treating women with stage I or stage II breast cancer who have undergone surgery to remove the tumor
PURPOSE This randomized phase III trial is studying combination chemotherapy alone to see how well it works compared to combination chemotherapy and epirubicin in treating women with stage I or stage II breast cancer who have undergone surgery to remove the tumor
Detailed Description:
OBJECTIVES
Compare disease-free and overall survival of women with early stage breast cancer treated with adjuvant cyclophosphamide methotrexate and fluorouracil with or without epirubicin
Compare the quality of life in a subgroup of these patients treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to radiotherapy timing concurrent versus sequential nodal status negative versus 1-3 versus at least 4 age 50 and under versus over 50 grade and tumor size Patients are randomized to one of two treatment arms
Arm I Patients receive oral cyclophosphamide on days 1-14 and methotrexate IV and fluorouracil IV on days 1 and 8 Treatment repeats every 4 weeks for 6 courses
Arm II Patients receive epirubicin IV on day 1 every 3 weeks for 4 courses followed by cyclophosphamide methotrexate and fluorouracil as in arm I for 4 courses
Some patients may receive radiotherapy during or after chemotherapy Treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed in a subset of patients N500 before chemotherapy starts at 3 months of treatment at the end of chemotherapy and at 6 12 and 18 months after treatment
Patients are followed annually for 10 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL Approximately 2000 patients will be accrued for this study within 4 years
Compare disease-free and overall survival of women with early stage breast cancer treated with adjuvant cyclophosphamide methotrexate and fluorouracil with or without epirubicin
Compare the quality of life in a subgroup of these patients treated with these regimens
OUTLINE This is a randomized study Patients are stratified according to radiotherapy timing concurrent versus sequential nodal status negative versus 1-3 versus at least 4 age 50 and under versus over 50 grade and tumor size Patients are randomized to one of two treatment arms
Arm I Patients receive oral cyclophosphamide on days 1-14 and methotrexate IV and fluorouracil IV on days 1 and 8 Treatment repeats every 4 weeks for 6 courses
Arm II Patients receive epirubicin IV on day 1 every 3 weeks for 4 courses followed by cyclophosphamide methotrexate and fluorouracil as in arm I for 4 courses
Some patients may receive radiotherapy during or after chemotherapy Treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed in a subset of patients N500 before chemotherapy starts at 3 months of treatment at the end of chemotherapy and at 6 12 and 18 months after treatment
Patients are followed annually for 10 years
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL Approximately 2000 patients will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-98041 | None | None | None |
| CRC-TU-NEAT | None | None | None |