Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087178
Status:
COMPLETED
Last Update Posted:
2022-08-11
First Post:
2004-07-08
Brief Title:
Comparison of Two Combination Chemotherapy Regimens in Treating Women With Breast Cancer
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Clinical Trial Of Adjuvant Therapy Comparing Six Cycles Of 5-Fluorouracil Epirubicin And Cyclophosphamide FEC To Four Cycles Of Adriamycin And Cyclophosphamide AC In Patients With Node-Negative Breast Cancer
Status:
COMPLETED
Status Verified Date:
2022-08
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:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as fluorouracil epirubicin cyclophosphamide and doxorubicin work in 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 in treating breast cancer
PURPOSE This randomized phase III trial is studying two combination chemotherapy regimens to compare how well they work in treating women who have undergone surgery for breast cancer that has not spread to the lymph nodes
PURPOSE This randomized phase III trial is studying two combination chemotherapy regimens to compare how well they work in treating women who have undergone surgery for breast cancer that has not spread to the lymph nodes
Detailed Description:
OBJECTIVES
Primary
Compare disease-free survival of women with node-negative breast cancer treated with adjuvant fluorouracil epirubicin and cyclophosphamide vs doxorubicin and cyclophosphamide
Secondary
Compare survival recurrence-free interval and distant recurrence-free interval in patients treated with these regimens
Compare adverse events in patients treated with these regimens
Compare quality of life with regard to physical functioning vitality symptoms and rates of post-chemotherapy amenorrhea in premenopausal patients treated with these regimens
Determine the effect of induction of post-chemotherapy amenorrhea on disease-free survival in premenopausal patients treated with these regimens
Correlate post-chemotherapy amenorrhea and disease-free survival with hormone receptor status in premenopausal patients treated with these regimens
Correlate changes in left ventricular ejection fraction LVEF with self-reported physical functioning in patients treated with these regimens
Compare the efficacy of these regimens in patients with Human Epidermal Growth Factor Receptor 2 HER2neu andor topoisomerase-2-alpha gene amplification
OUTLINE This is a randomized multicenter study Patients are stratified according to hormone receptor status estrogen receptor ER positive or progesterone receptor PR positive vs ER negative or PR negative and type of prior surgery lumpectomy vs total mastectomy Patients are randomized to 1 of 2 treatment arms
Arm 1 Patients receive doxorubicin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1 Treatment repeats every 21 days for 4 courses
Arm 2 Patients receive fluorouracil IV epirubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1 Treatment repeats every 21 days for 6 courses
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
All patients with ER- or PR-positive tumors receive hormonal therapy daily beginning within 3-12 weeks after the completion of chemotherapy and continuing for at least 5 years
All patients who have undergone prior lumpectomy undergo whole-breast radiotherapy beginning as soon as possible after the completion of chemotherapy Patients who have undergone prior total mastectomy may undergo chest wall radiotherapy at the investigators discretion Patients assigned to the partial breast irradiation PBI group of protocol NSABP-B-39 undergo PBI according to protocol-specific guidelines
Quality of life is assessed at baseline on day 1 of course 4 of chemotherapy and then every 6 months for 3 years
Patients are followed every 6 months for up to 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 2700 patients 1350 per treatment arm will be accrued for this study within 375 years
Primary
Compare disease-free survival of women with node-negative breast cancer treated with adjuvant fluorouracil epirubicin and cyclophosphamide vs doxorubicin and cyclophosphamide
Secondary
Compare survival recurrence-free interval and distant recurrence-free interval in patients treated with these regimens
Compare adverse events in patients treated with these regimens
Compare quality of life with regard to physical functioning vitality symptoms and rates of post-chemotherapy amenorrhea in premenopausal patients treated with these regimens
Determine the effect of induction of post-chemotherapy amenorrhea on disease-free survival in premenopausal patients treated with these regimens
Correlate post-chemotherapy amenorrhea and disease-free survival with hormone receptor status in premenopausal patients treated with these regimens
Correlate changes in left ventricular ejection fraction LVEF with self-reported physical functioning in patients treated with these regimens
Compare the efficacy of these regimens in patients with Human Epidermal Growth Factor Receptor 2 HER2neu andor topoisomerase-2-alpha gene amplification
OUTLINE This is a randomized multicenter study Patients are stratified according to hormone receptor status estrogen receptor ER positive or progesterone receptor PR positive vs ER negative or PR negative and type of prior surgery lumpectomy vs total mastectomy Patients are randomized to 1 of 2 treatment arms
Arm 1 Patients receive doxorubicin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1 Treatment repeats every 21 days for 4 courses
Arm 2 Patients receive fluorouracil IV epirubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1 Treatment repeats every 21 days for 6 courses
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
All patients with ER- or PR-positive tumors receive hormonal therapy daily beginning within 3-12 weeks after the completion of chemotherapy and continuing for at least 5 years
All patients who have undergone prior lumpectomy undergo whole-breast radiotherapy beginning as soon as possible after the completion of chemotherapy Patients who have undergone prior total mastectomy may undergo chest wall radiotherapy at the investigators discretion Patients assigned to the partial breast irradiation PBI group of protocol NSABP-B-39 undergo PBI according to protocol-specific guidelines
Quality of life is assessed at baseline on day 1 of course 4 of chemotherapy and then every 6 months for 3 years
Patients are followed every 6 months for up to 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 2700 patients 1350 per treatment arm will be accrued for this study within 375 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 |
|---|---|---|---|
| U10CA012027 | NIH | None | httpsreporternihgovquickSearchU10CA012027 |