Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054587
Status:
COMPLETED
Last Update Posted:
2013-07-19
First Post:
2003-02-05
Brief Title:
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Randomized And Multicentric Opened Phase III Study Evaluating The Concomitant Administration Of Docetaxel 75MGM2 and Epirubicine 75MGM2 Versus FEC 100 In Non Metastatic With Positive Lymphatic Nodes Breast Cancer Subjects And The Sequential Addition Of Herceptin In HER2 And HER2 And FISH Subjects
Status:
COMPLETED
Status Verified Date:
2013-07
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 Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Radiation therapy uses high-energy x-rays to damage tumor cells It is not yet known which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more effective in treating breast cancer
PURPOSE Randomized phase III trial to compare two different chemotherapy regimens plus radiation therapy with or without trastuzumab in treating women who have breast cancer that has spread to lymph nodes in the axilla under the arm
PURPOSE Randomized phase III trial to compare two different chemotherapy regimens plus radiation therapy with or without trastuzumab in treating women who have breast cancer that has spread to lymph nodes in the axilla under the arm
Detailed Description:
OBJECTIVES
Compare the efficacy of adjuvant cyclophosphamide epirubicin and fluorouracil vs adjuvant docetaxel and epirubicin in terms of 5-year survival without relapse in women with nonmetastatic adenocarcinoma of the breast with lymph node invasion
Determine survival of patients treated with these regimens
Compare the tolerability of trastuzumab Herceptin in patients treated with these regimens
Determine the efficacy and tolerability of trastuzumab in patients with hormone receptor-positive tumors
Evaluate the quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to participating center Patients are treated in 2 parts
Part I Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fluorouracil IV or epirubicin IV and cyclophosphamide IV on day 1 Treatment repeats every 3 weeks for 6 courses Patients then undergo radiotherapy 5 days a week for 5 weeks
Arm II Patients receive epirubicin IV over 10 minutes and docetaxel IV over 1 hour on day 1 Treatment repeats every 3 weeks for 6 courses Patients then undergo radiotherapy as in arm I
Patients with HER2neu-positive tumors then proceed to part II Patients with HER2neu-negative tumors receive no further treatment
Patients with hormone estrogen or progesterone receptor-positive tumors also receive oral tamoxifen daily beginning after chemotherapy is completed and continuing for 5 years
Part II Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive trastuzumab Herceptin IV over 30-90 minutes every 3 weeks for 1 year
Arm II Patients are followed without treatment Patients not receiving trastuzumab are followed at 4 months 6 months every 4 months for 1 year and then every 6 months for 3 years Patients receiving trastuzumab are followed at 4 months and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 2600 patients will be accrued for this study within 3 years
Compare the efficacy of adjuvant cyclophosphamide epirubicin and fluorouracil vs adjuvant docetaxel and epirubicin in terms of 5-year survival without relapse in women with nonmetastatic adenocarcinoma of the breast with lymph node invasion
Determine survival of patients treated with these regimens
Compare the tolerability of trastuzumab Herceptin in patients treated with these regimens
Determine the efficacy and tolerability of trastuzumab in patients with hormone receptor-positive tumors
Evaluate the quality of life of patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to participating center Patients are treated in 2 parts
Part I Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fluorouracil IV or epirubicin IV and cyclophosphamide IV on day 1 Treatment repeats every 3 weeks for 6 courses Patients then undergo radiotherapy 5 days a week for 5 weeks
Arm II Patients receive epirubicin IV over 10 minutes and docetaxel IV over 1 hour on day 1 Treatment repeats every 3 weeks for 6 courses Patients then undergo radiotherapy as in arm I
Patients with HER2neu-positive tumors then proceed to part II Patients with HER2neu-negative tumors receive no further treatment
Patients with hormone estrogen or progesterone receptor-positive tumors also receive oral tamoxifen daily beginning after chemotherapy is completed and continuing for 5 years
Part II Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive trastuzumab Herceptin IV over 30-90 minutes every 3 weeks for 1 year
Arm II Patients are followed without treatment Patients not receiving trastuzumab are followed at 4 months 6 months every 4 months for 1 year and then every 6 months for 3 years Patients receiving trastuzumab are followed at 4 months and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 2600 patients will be accrued for this study within 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 |
|---|---|---|---|
| PACS04 | OTHER | UNICANCER | None |
| FRE-FNCLCC-PACS-040005 | None | None | None |
| EU-20236 | None | None | None |