Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005581
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2000-05-02
Brief Title:
Combination Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer
Sponsor:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro Genoa Italy
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Epirubicin Plus Paclitaxel Versus Cyclophosphamide Epirubicin and 5-Fluorouracil as Adjuvant Treatment of Node Positive Breast Cancer Patients A Controlled Randomized Phase III Study
Status:
UNKNOWN
Status Verified Date:
2007-06
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 may kill more tumor cells It is not yet known which regimen of chemotherapy is more effective for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating women who have stage II or stage III breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating women who have stage II or stage III breast cancer
Detailed Description:
OBJECTIVES I Compare overall survival and disease free survival after adjuvant chemotherapy with epirubicin plus paclitaxel versus cyclophosphamide epirubicin and fluorouracil in women with stage IIA IIB or III breast cancer II Compare quality of life in these women with these treatment regimens
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms within 35 days of surgery Arm I Patients receive epirubicin IV followed by paclitaxel IV over 3 hours on day 1 Treatment repeats every 21 days for 4 courses Arm II Patients receive cyclophosphamide IV epirubicin IV and fluorouracil IV on day 1 Treatment repeats every 21 days for 6 courses Treatment continues in the absence of disease progression or unacceptable toxicity Patients who are postmenopausal or premenopausal and hormone receptor positive receive tamoxifen orally once a day for 5 years starting on day 1 Patients receive radiotherapy to residual breast after 4 courses of chemotherapy Quality of life is assessed Patients are followed every 3 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 1000 patients will be accrued for this study over 5 years
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms within 35 days of surgery Arm I Patients receive epirubicin IV followed by paclitaxel IV over 3 hours on day 1 Treatment repeats every 21 days for 4 courses Arm II Patients receive cyclophosphamide IV epirubicin IV and fluorouracil IV on day 1 Treatment repeats every 21 days for 6 courses Treatment continues in the absence of disease progression or unacceptable toxicity Patients who are postmenopausal or premenopausal and hormone receptor positive receive tamoxifen orally once a day for 5 years starting on day 1 Patients receive radiotherapy to residual breast after 4 courses of chemotherapy Quality of life is assessed Patients are followed every 3 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 1000 patients will be accrued for this study over 5 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 |
|---|---|---|---|
| NCI-V99-1562 | None | None | None |
| INRC-GONO-MIG-5 | None | None | None |