Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008034
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
2001-01-06
Brief Title:
Combination Chemotherapy Before Surgery in Treating Women With Breast Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Phase I Study Of Cyclophoshamide And Epirubicin In Combination With Capecitabine XELODA CEX As Primary Treatment Of Locally AdvancedInflammatory Or Large Operable Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-07
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 Combining more than one drug may kill more tumor cells and shrink tumors so they can be removed during surgery
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy before surgery in treating women who have locally advanced inflammatory or large surgically removable breast cancer
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy before surgery in treating women who have locally advanced inflammatory or large surgically removable breast cancer
Detailed Description:
OBJECTIVES I Determine the toxicity of neoadjuvant capecitabine cyclophosphamide and epirubicin in women with locally advanced or inflammatory or large operable breast cancer II Determine the maximum tolerated dose of this regimen in this patient population
OUTLINE This is a multicenter dose escalation study of capecitabine Patients receive neoadjuvant cyclophosphamide IV and epirubicin IV on day 1 and oral capecitabine twice daily on days 1-14 Treatment continues every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL A total of 3-33 patients will be accrued for this study
OUTLINE This is a multicenter dose escalation study of capecitabine Patients receive neoadjuvant cyclophosphamide IV and epirubicin IV on day 1 and oral capecitabine twice daily on days 1-14 Treatment continues every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL A total of 3-33 patients will be accrued for this study
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 |
|---|---|---|---|
| EORTC-10991 | None | None | None |
| IDBBC-10991-CEX | None | None | None |