Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072319
Status:
COMPLETED
Last Update Posted:
2013-03-04
First Post:
2003-11-04
Brief Title:
Neoadjuvant or Adjuvant Epirubicin Cyclophosphamide and Paclitaxel in Treating Women With Stage I Stage II or Stage III Breast Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Pilot Study of Epirubicin and Cyclophosphamide Followed by Paclitaxel at 10-11 Days Interval for Women With Early Breast Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-03
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 and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery Giving chemotherapy drugs after surgery may kill any remaining tumor cells
PURPOSE Pilot trial to study the effectiveness of neoadjuvant or adjuvant epirubicin cyclophosphamide and paclitaxel in treating women who have stage I stage II or stage III breast cancer
PURPOSE Pilot trial to study the effectiveness of neoadjuvant or adjuvant epirubicin cyclophosphamide and paclitaxel in treating women who have stage I stage II or stage III breast cancer
Detailed Description:
OBJECTIVES
Determine the feasibility and safety of neoadjuvant or adjuvant epirubicin cyclophosphamide and paclitaxel in terms of the absence of any grade 3 or higher toxicity aside from alopecia in women with high-risk stage I-III breast cancer
OUTLINE This is a pilot study
Neoadjuvant or adjuvant EC therapy Patients receive epirubicin IV over 3-5 minutes and cyclophosphamide IV EC on day 1 and filgrastim G-CSF subcutaneously on days 2-9 or 10 Treatment repeats every 10-11 days for 4 courses in the absence of disease progression or unacceptable toxicity
Neoadjuvant or adjuvant paclitaxel therapy After the completion of EC therapy patients receive paclitaxel IV over 3 hours on day 1 Patients also receive G-CSF as in EC therapy Treatment repeats every 10-11 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients who have not had prior surgery undergo definitive surgery after the completion of chemotherapy Patients also may receive adjuvant radiotherapy andor hormonal therapy at the discretion of the treating physician
Patients are followed every 4 months for 3 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 11-38 patients will be accrued for this study within 1 year
Determine the feasibility and safety of neoadjuvant or adjuvant epirubicin cyclophosphamide and paclitaxel in terms of the absence of any grade 3 or higher toxicity aside from alopecia in women with high-risk stage I-III breast cancer
OUTLINE This is a pilot study
Neoadjuvant or adjuvant EC therapy Patients receive epirubicin IV over 3-5 minutes and cyclophosphamide IV EC on day 1 and filgrastim G-CSF subcutaneously on days 2-9 or 10 Treatment repeats every 10-11 days for 4 courses in the absence of disease progression or unacceptable toxicity
Neoadjuvant or adjuvant paclitaxel therapy After the completion of EC therapy patients receive paclitaxel IV over 3 hours on day 1 Patients also receive G-CSF as in EC therapy Treatment repeats every 10-11 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients who have not had prior surgery undergo definitive surgery after the completion of chemotherapy Patients also may receive adjuvant radiotherapy andor hormonal therapy at the discretion of the treating physician
Patients are followed every 4 months for 3 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 11-38 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| MSKCC-03092 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |