Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039546
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2002-06-06
Brief Title:
Combination Chemotherapy in Treating Women With Breast Cancer Who Have Undergone Surgery
Sponsor:
Cancer Research Campaign Clinical Trials Centre
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
tAnGo A Phase III Randomised Trial Of Gemcitabine In Paclitaxel-Containing Epirubicin-Based Adjuvant Chemotherapy For ERPgR-Poor Early Stage Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2005-05
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 may kill more tumor cells It is not yet known which chemotherapy regimen is more effective in treating women after surgery for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of paclitaxel epirubicin and cyclophosphamide with or without gemcitabine in treating women who have undergone surgery for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of paclitaxel epirubicin and cyclophosphamide with or without gemcitabine in treating women who have undergone surgery for breast cancer
Detailed Description:
OBJECTIVES
Compare the 5-year and 10-year disease-free survival and overall survival of women with completely resected early stage breast cancer treated with adjuvant paclitaxel epirubicin and cyclophosphamide with or without gemcitabine
Compare the toxicity dose-intensity and tolerability of these regimens in these patients
Compare the serious adverse events in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to nodal status negative vs 1-3 vs 4 or more age 50 and under vs over 50 estrogen receptor status negative vs weakly positive vs positive concurrent radiotherapy no vs yes HER2 status 3 overexpression vs other vs not measured and country Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive epirubicin IV cyclophosphamide IV and paclitaxel IV over 3 hours on day 1 Patients also receive gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive epirubicin cyclophosphamide and paclitaxel as in arm I
Patients are followed every 3 months for 6 months every 6 months for 3 years and then annually for 6 years
PROJECTED ACCRUAL A total of 3000 patients 1500 per treatment arm will be accrued for this study within 3-4 years
Compare the 5-year and 10-year disease-free survival and overall survival of women with completely resected early stage breast cancer treated with adjuvant paclitaxel epirubicin and cyclophosphamide with or without gemcitabine
Compare the toxicity dose-intensity and tolerability of these regimens in these patients
Compare the serious adverse events in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to nodal status negative vs 1-3 vs 4 or more age 50 and under vs over 50 estrogen receptor status negative vs weakly positive vs positive concurrent radiotherapy no vs yes HER2 status 3 overexpression vs other vs not measured and country Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive epirubicin IV cyclophosphamide IV and paclitaxel IV over 3 hours on day 1 Patients also receive gemcitabine IV over 30 minutes on days 1 and 8 Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients receive epirubicin cyclophosphamide and paclitaxel as in arm I
Patients are followed every 3 months for 6 months every 6 months for 3 years and then annually for 6 years
PROJECTED ACCRUAL A total of 3000 patients 1500 per treatment arm will be accrued for this study within 3-4 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-20058 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069396 | REGISTRY | None | None |