Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033683
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
2002-04-09
Brief Title:
Combination Chemotherapy in Treating Women With Resected Breast Cancer
Sponsor:
Institute of Cancer Research United Kingdom
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomised Trial Of Standard Anthracycline-Based Chemotherapy With Fluorouracil Epirubicin And Cyclophosphamide FEC Or Epirubicin And CMF Epi-CMF Versus FEC Followed By Sequential Docetaxel As Adjuvant Treatment For Women With Early Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2005-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 tumor cells remaining after surgery It is not yet known which combination chemotherapy regimen is more effective in treating resected stage I or stage II breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating women who have resected stage I or stage II breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating women who have resected stage I or stage II breast cancer
Detailed Description:
OBJECTIVES
Compare the disease-free and overall survival of women with completely resected stage I or II breast cancer adjuvantly treated with fluorouracil epirubicin and cyclophosphamide FEC or epirubicin followed by cyclophosphamide methotrexate and fluorouracil EPI-CMF versus FEC followed by sequential docetaxel
Compare the acute toxicity of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center estrogen receptor status positive vs negative and nodal status Within 8 weeks after definitive surgery patients are randomized to 1 of 2 treatment arms
Arm I Patients are assigned to 1 of 2 standard adjuvant chemotherapy regimens
Regimen A Patients receive fluorouracil epirubicin and cyclophosphamide FEC IV on day 1 Treatment repeats every 3 weeks for 8 courses
Regimen B Patients receive epirubicin IV on day 1 Treatment repeats every 3 weeks for 4 courses Patients then receive cyclophosphamide orally on days 1-14 or IV on days 1 and 8 and methotrexate IV and fluorouracil IV on days 1 and 8 CMF Treatment with CMF repeats every 4 weeks for 4 courses
Arm II Patients receive 4 courses of adjuvant chemotherapy with FEC as in arm I regimen A Patients then receive sequential docetaxel IV over 1 hour once every 3 weeks for 4 courses
Beginning within 4 weeks after completion of adjuvant chemotherapy patients who are not concurrently enrolled in the Standardization of Breast Radiotherapy START trial receive localized radiotherapy once daily 5 days a week for 3-5 weeks according to local practice
Beginning within 4 weeks after completion of adjuvant chemotherapy patients who are estrogen receptor andor progesterone receptor positive receive oral tamoxifen once daily for at least 5 years
Quality of life is assessed at baseline before course 5 at 3-4 weeks after course 8 and then at 9 12 18 and 24 months after initiation of adjuvant chemotherapy
Patients are followed every 3 months for 2 years and then every 6 months thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 3340 patients 1670 per treatment arm will be accrued for this study within 2 years
Compare the disease-free and overall survival of women with completely resected stage I or II breast cancer adjuvantly treated with fluorouracil epirubicin and cyclophosphamide FEC or epirubicin followed by cyclophosphamide methotrexate and fluorouracil EPI-CMF versus FEC followed by sequential docetaxel
Compare the acute toxicity of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center estrogen receptor status positive vs negative and nodal status Within 8 weeks after definitive surgery patients are randomized to 1 of 2 treatment arms
Arm I Patients are assigned to 1 of 2 standard adjuvant chemotherapy regimens
Regimen A Patients receive fluorouracil epirubicin and cyclophosphamide FEC IV on day 1 Treatment repeats every 3 weeks for 8 courses
Regimen B Patients receive epirubicin IV on day 1 Treatment repeats every 3 weeks for 4 courses Patients then receive cyclophosphamide orally on days 1-14 or IV on days 1 and 8 and methotrexate IV and fluorouracil IV on days 1 and 8 CMF Treatment with CMF repeats every 4 weeks for 4 courses
Arm II Patients receive 4 courses of adjuvant chemotherapy with FEC as in arm I regimen A Patients then receive sequential docetaxel IV over 1 hour once every 3 weeks for 4 courses
Beginning within 4 weeks after completion of adjuvant chemotherapy patients who are not concurrently enrolled in the Standardization of Breast Radiotherapy START trial receive localized radiotherapy once daily 5 days a week for 3-5 weeks according to local practice
Beginning within 4 weeks after completion of adjuvant chemotherapy patients who are estrogen receptor andor progesterone receptor positive receive oral tamoxifen once daily for at least 5 years
Quality of life is assessed at baseline before course 5 at 3-4 weeks after course 8 and then at 9 12 18 and 24 months after initiation of adjuvant chemotherapy
Patients are followed every 3 months for 2 years and then every 6 months thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 3340 patients 1670 per treatment arm will be accrued for this study within 2 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-20109 | None | None | None |
| ICR-TACT | None | None | None |