Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-28 @ 5:17 AM
Study NCT ID:
NCT00751868
Status:
COMPLETED
Last Update Posted:
2014-12-17
First Post:
2008-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FEC With G-CSF Support Followed by Ixabepilone With G-CSF Support as Neoadjuvant Chemotherapy in BC
Sponsor:
Consorzio Oncotech
Organization:
Study Overview
Official Title:
NEO-ADIXERN (NEO-ADjuvant IXabepilone in Breast Cancer). A Feasibility Study of Dose-dense FEC With G-CSF Support Followed by Dose-dense Ixabepilone With G-CSF Support as Neoadjuvant Chemotherapy in Breast Cancer
Status:
COMPLETED
Status Verified Date:
2014-12
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:
GIM9
Brief Summary:
The purpose of this study is to assess the feasibility of Ixabepilone (4 cycles) administered every 14 days with the support of G-CSF sequentially to the combination of Fluorouracil, Epirubicin and Cyclophosphamide (4 cycles) administered every 14 days with the support of G-CSF.
To evaluate the efficacy (in terms of pathologic Complete Responses in the breast and in the axilla), the dose reduction rate, the median treatment delay and the discontinuation rate due to toxicity of the regimen.
To evaluate the efficacy (in terms of pathologic Complete Responses in the breast and in the axilla), the dose reduction rate, the median treatment delay and the discontinuation rate due to toxicity of the regimen.
Detailed Description:
Estrogen receptor negative breast cancer may be defined as distinct biologic subtype disease, more aggressive with a typical molecular portrait. \[30\] This subtype seems to have a poor prognosis and poor treatment options because these patients are not candidate to hormonal therapy. Novel treatment strategies focusing upon this subtype are necessary in the future. \[31\] There are reports of clinical benefit in estrogen receptor negative patients treated with dose-dense chemotherapy (see background CALGB 9741 and MIG-1 study). In the CALGB 9741 study, patients randomized to receive dose-dense regimens experienced severe toxicities during paclitaxel treatment leading to dose reduction in 7% and 5%respectively.
Ixabepilone has shown consistent activity and an acceptable safety profile in patients with all stages breast cancer. This phase II study evaluate the feasibility of dose-dense Ixabepilone (4 cycles) given sequentially to the combination of Fluorouracil, Epirubicin and Cyclophosphamide (4 cycles) all given every 14 days with the support of Filgrastim as neo-adjuvant treatment for ER-negative breast cancer patients.
Ixabepilone has shown consistent activity and an acceptable safety profile in patients with all stages breast cancer. This phase II study evaluate the feasibility of dose-dense Ixabepilone (4 cycles) given sequentially to the combination of Fluorouracil, Epirubicin and Cyclophosphamide (4 cycles) all given every 14 days with the support of Filgrastim as neo-adjuvant treatment for ER-negative breast cancer patients.
Study Oversight
Has Oversight DMC:
True
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?: