Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004175
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
1999-12-10
Brief Title:
Docetaxel Doxorubicin and Cyclophosphamide in Treating Women With Stage III Breast Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase II Study of Taxotere Doxorubicin and Cyclophosphamide TAC Primary Therapy in Stage III Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-05
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 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
PURPOSE Phase II trial to study the effectiveness of combining docetaxel doxorubicin and cyclophosphamide in treating women who have previously untreated stage III breast cancer
PURPOSE Phase II trial to study the effectiveness of combining docetaxel doxorubicin and cyclophosphamide in treating women who have previously untreated stage III breast cancer
Detailed Description:
OBJECTIVES I Determine the clinical response rate to docetaxel doxorubicin and cyclophosphamide as primary therapy in women with stage III breast cancer II Determine the pathologic complete response rate to this treatment regimen in this patient population III Assess the side effects and toxicity profile of this treatment regimen in these patients
OUTLINE This is an open label multicenter study Patients receive doxorubicin IV over 5-10 minutes followed by cyclophosphamide IV over 5-10 minutes and docetaxel IV over 1 hour Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Within 5 weeks following completion of chemotherapy operable patients achieving complete or partial response undergo mastectomy segmental mastectomy or lumpectomy with nodal dissection Patients with positive surgical tumor margins may undergo an additional surgical procedure Patients are followed for survival
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 1 year
OUTLINE This is an open label multicenter study Patients receive doxorubicin IV over 5-10 minutes followed by cyclophosphamide IV over 5-10 minutes and docetaxel IV over 1 hour Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Within 5 weeks following completion of chemotherapy operable patients achieving complete or partial response undergo mastectomy segmental mastectomy or lumpectomy with nodal dissection Patients with positive surgical tumor margins may undergo an additional surgical procedure Patients are followed for survival
PROJECTED ACCRUAL A total of 40 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 |
|---|---|---|---|
| NCI-G99-1643 | None | None | None |
| NU-98B1 | None | None | None |