Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016406
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2001-05-06
Brief Title:
S0012 Doxorubicin Cyclophosphamide and Paclitaxel With or Without Filgrastim in Treating Women With Inflammatory or Locally Advanced Breast Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Comparative Randomized Study of Standard Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel Vs Weekly Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF Followed by Weekly Paclitaxel As Neoadjuvant Therapy For Inflammatory and Locally Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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 It is not yet known whether combination chemotherapy is more effective with or without filgrastim in treating breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combining doxorubicin cyclophosphamide and paclitaxel with or without filgrastim in treating women who have inflammatory or locally advanced breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combining doxorubicin cyclophosphamide and paclitaxel with or without filgrastim in treating women who have inflammatory or locally advanced breast cancer
Detailed Description:
OBJECTIVES
Compare the microscopic pathologic response rates in women with inflammatory or locally advanced breast cancer treated with standard neoadjuvant doxorubicin and cyclophosphamide followed by weekly paclitaxel vs weekly doxorubicin and daily oral cyclophosphamide with filgrastim G-CSF followed by weekly paclitaxel
Compare the toxic effects of these regimens in this patient population
Compare the delivered dose intensity of these regimens in this patient population
Evaluate the association between microscopic pathologic complete response and clinical complete response at the primary tumor site in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to disease status inflammatory vs other Patients are randomized to one of two treatment arms
Arm I Patients receive doxorubicin IV followed by cyclophosphamide IV on day 1 Treatment repeats every 21 days for a total of 5 courses in the absence of disease progression or unacceptable toxicity Three weeks after completion of doxorubicin and cyclophosphamide patients receive paclitaxel IV over 1 hour weekly on day 1 for a total of 12 weeks
Arm II Patients receive doxorubicin IV on day 1 oral cyclophosphamide on days 1-7 and filgrastim G-CSF subcutaneously on days 2-7 Treatment repeats weekly for a total of 15 courses of doxorubicin and cyclophosphamide and 16 courses of G-CSF in the absence of disease progression or unacceptable toxicity One week after completion of G-CSF patients receive paclitaxel as in arm I
Within 3-6 weeks after completion of chemotherapy patients with stable or responsive disease undergo surgical resection of tumor and affected nodes
After surgery patients may receive radiotherapy or additional chemotherapy andor hormonal therapy at the discretion of the treating physician
Patients are followed every 6 months for 1 year and then annually for 4 years
PROJECTED ACCRUAL A total of 350 patients 175 per treatment arm will be accrued for this study within 3 years
Compare the microscopic pathologic response rates in women with inflammatory or locally advanced breast cancer treated with standard neoadjuvant doxorubicin and cyclophosphamide followed by weekly paclitaxel vs weekly doxorubicin and daily oral cyclophosphamide with filgrastim G-CSF followed by weekly paclitaxel
Compare the toxic effects of these regimens in this patient population
Compare the delivered dose intensity of these regimens in this patient population
Evaluate the association between microscopic pathologic complete response and clinical complete response at the primary tumor site in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to disease status inflammatory vs other Patients are randomized to one of two treatment arms
Arm I Patients receive doxorubicin IV followed by cyclophosphamide IV on day 1 Treatment repeats every 21 days for a total of 5 courses in the absence of disease progression or unacceptable toxicity Three weeks after completion of doxorubicin and cyclophosphamide patients receive paclitaxel IV over 1 hour weekly on day 1 for a total of 12 weeks
Arm II Patients receive doxorubicin IV on day 1 oral cyclophosphamide on days 1-7 and filgrastim G-CSF subcutaneously on days 2-7 Treatment repeats weekly for a total of 15 courses of doxorubicin and cyclophosphamide and 16 courses of G-CSF in the absence of disease progression or unacceptable toxicity One week after completion of G-CSF patients receive paclitaxel as in arm I
Within 3-6 weeks after completion of chemotherapy patients with stable or responsive disease undergo surgical resection of tumor and affected nodes
After surgery patients may receive radiotherapy or additional chemotherapy andor hormonal therapy at the discretion of the treating physician
Patients are followed every 6 months for 1 year and then annually for 4 years
PROJECTED ACCRUAL A total of 350 patients 175 per treatment arm will be accrued for this study within 3 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0012 | OTHER | None | None |