Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433420
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2007-02-08
Brief Title:
Combination Chemotherapy With or Without Fluorouracil andor Pegfilgrastim in Treating Women With Node-Positive Breast Cancer
Sponsor:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro Genoa Italy
Organization:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro Genoa Italy
Study Overview
Official Title:
A Phase III Randomized Study of EC Followed by Paclitaxel Versus FEC Followed by Paclitaxel All Given Either Every 3 Weeks or 2 Weeks Supported by Pegfilgrastim for Node Positive Breast Cancer Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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 such as epirubicin cyclophosphamide paclitaxel and fluorouracil work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Colony-stimulating factors such as pegfilgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy Giving combination chemotherapy and pegfilgrastim after surgery may kill any tumor cells that remain after surgery It is not yet known whether combination chemotherapy is more effective with or without fluorouracil andor pegfilgrastim in treating breast cancer
PURPOSE This randomized phase III trial is studying combination chemotherapy to compare how well it works when given with or without fluorouracil andor pegfilgrastim in treating women with node-positive breast cancer
PURPOSE This randomized phase III trial is studying combination chemotherapy to compare how well it works when given with or without fluorouracil andor pegfilgrastim in treating women with node-positive breast cancer
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of adjuvant therapy comprising epirubicin hydrochloride cyclophosphamide and paclitaxel with vs without fluorouracil andor pegfilgrastim in women with node-positive breast cancer
Secondary
Compare the overall survival of patients treated with these regimens
Compare the safety of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive epirubicin hydrochloride IV and cyclophosphamide IV on day 1 Treatment repeats every 3 weeks for 4 courses Patients then receive paclitaxel IV over 3 hours on day 1 Treatment with paclitaxel repeats every 3 weeks for 4 courses
Arm II Patients receive fluorouracil IV epirubicin hydrochloride IV and cyclophosphamide IV on day 1 Treatment repeats every 3 weeks for 4 courses Patients then receive paclitaxel as in arm I
Arm III Patients receive epirubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously SC on day 4 Treatment repeats every 2 weeks for 4 courses Patients then receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim subcutaneously SC on day 4 Treatment with paclitaxel and pegfilgrastim repeats every 2 weeks for 4 courses
Arm IV Patients receive fluorouracil IV epirubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 4 Treatment repeats every 2 weeks for 4 courses Patients then receive paclitaxel and pegfilgrastim as in arm III
In all arms treatment continues in the absence of disease progression or unacceptable toxicity After completion of chemotherapy with or without pegfilgrastim patients may undergo external-beam radiation therapy at the discretion of treating center Patients with positive estrogen andor progesterone receptor tumor receive tamoxifen for 5 years
After completion of study treatment patients are followed periodically for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 2000 patients will be accrued for this study
Primary
Compare the efficacy of adjuvant therapy comprising epirubicin hydrochloride cyclophosphamide and paclitaxel with vs without fluorouracil andor pegfilgrastim in women with node-positive breast cancer
Secondary
Compare the overall survival of patients treated with these regimens
Compare the safety of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive epirubicin hydrochloride IV and cyclophosphamide IV on day 1 Treatment repeats every 3 weeks for 4 courses Patients then receive paclitaxel IV over 3 hours on day 1 Treatment with paclitaxel repeats every 3 weeks for 4 courses
Arm II Patients receive fluorouracil IV epirubicin hydrochloride IV and cyclophosphamide IV on day 1 Treatment repeats every 3 weeks for 4 courses Patients then receive paclitaxel as in arm I
Arm III Patients receive epirubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously SC on day 4 Treatment repeats every 2 weeks for 4 courses Patients then receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim subcutaneously SC on day 4 Treatment with paclitaxel and pegfilgrastim repeats every 2 weeks for 4 courses
Arm IV Patients receive fluorouracil IV epirubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 4 Treatment repeats every 2 weeks for 4 courses Patients then receive paclitaxel and pegfilgrastim as in arm III
In all arms treatment continues in the absence of disease progression or unacceptable toxicity After completion of chemotherapy with or without pegfilgrastim patients may undergo external-beam radiation therapy at the discretion of treating center Patients with positive estrogen andor progesterone receptor tumor receive tamoxifen for 5 years
After completion of study treatment patients are followed periodically for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 2000 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| EU-20681 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000528056 | REGISTRY | None | None |