Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047099
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2002-10-03
Brief Title:
Combination Chemotherapy in Treating Women With Breast Cancer
Sponsor:
Ludwig-Maximilians - University of Munich
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase III Trial Comparing FEC-Chemotherapy vs EC-Doc-Chemotherapy in Patients With Primary Breast Cancer
Status:
COMPLETED
Status Verified Date:
2002-12
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 and giving them after surgery may kill any remaining tumor cells following surgery It is not yet known which combination chemotherapy regimen is more effective in treating breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating women who have primary breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating women who have primary breast cancer
Detailed Description:
OBJECTIVES
Compare the time to progression of women with primary breast cancer treated with fluorouracil epirubicin and cyclophosphamide vs docetaxel epirubicin and cyclophosphamide
Compare the overall survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to metastatic axillary lymph node involvement 4-9 vs 10 or more hormone receptor status estrogen andor progesterone of the primary tumor negative vs positive and timing of adjuvant radiotherapy intermittently after completion of 50 of chemotherapy vs after completion of all chemotherapy Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fluorouracil IV over 10-15 minutes and epirubicin IV over 15 minutes on days 1 and 8 and oral cyclophosphamide on days 1-14 Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive epirubicin IV over 15 minutes and cyclophosphamide IV over 1 hour on days 1 21 42 and 63 and docetaxel IV over 1 hour on days 84 105 126 and 147 in the absence of disease progression or unacceptable toxicity
Within 21 days after the completion of chemotherapy patients undergo adjuvant radiotherapy 5 days a week for 55 weeks Alternatively patients may undergo radiotherapy intermittently after completion of 50 of chemotherapy
Upon completion of chemotherapy patients with positive hormone receptor status estrogen andor progesterone receive oral tamoxifen daily for 5 years Additionally patients with positive hormone receptor status who are under age 40 receive goserelin subcutaneously every 4 weeks for 2 years
Quality of life is assessed at baseline prior to each course of chemotherapy 4 weeks after completion of chemotherapy 6 weeks after completion of radiotherapy and then at 6 months after completion of chemotherapy
Patients are followed every 3 months for 3 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 446 patients 223 per treatment arm will be accrued for this study within 3 years
Compare the time to progression of women with primary breast cancer treated with fluorouracil epirubicin and cyclophosphamide vs docetaxel epirubicin and cyclophosphamide
Compare the overall survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to metastatic axillary lymph node involvement 4-9 vs 10 or more hormone receptor status estrogen andor progesterone of the primary tumor negative vs positive and timing of adjuvant radiotherapy intermittently after completion of 50 of chemotherapy vs after completion of all chemotherapy Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fluorouracil IV over 10-15 minutes and epirubicin IV over 15 minutes on days 1 and 8 and oral cyclophosphamide on days 1-14 Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive epirubicin IV over 15 minutes and cyclophosphamide IV over 1 hour on days 1 21 42 and 63 and docetaxel IV over 1 hour on days 84 105 126 and 147 in the absence of disease progression or unacceptable toxicity
Within 21 days after the completion of chemotherapy patients undergo adjuvant radiotherapy 5 days a week for 55 weeks Alternatively patients may undergo radiotherapy intermittently after completion of 50 of chemotherapy
Upon completion of chemotherapy patients with positive hormone receptor status estrogen andor progesterone receive oral tamoxifen daily for 5 years Additionally patients with positive hormone receptor status who are under age 40 receive goserelin subcutaneously every 4 weeks for 2 years
Quality of life is assessed at baseline prior to each course of chemotherapy 4 weeks after completion of chemotherapy 6 weeks after completion of radiotherapy and then at 6 months after completion of chemotherapy
Patients are followed every 3 months for 3 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 446 patients 223 per treatment arm will be accrued for this study within 3 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-20221 | None | None | None |
| LMU-ADEBAR | None | None | None |