Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002679
Status:
COMPLETED
Last Update Posted:
2009-08-26
First Post:
1999-11-01
Brief Title:
Adjuvant High-Dose Sequential Chemotherapy in Treating Patients With Resected Breast Cancer
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Sequential Adjuvant Chemotherapy With Doxorubicin Taxol and Cyclophosphamide for Stage II or III Resectable Breast Cancer With Four or More Involved Axillary Lymph Nodes
Status:
COMPLETED
Status Verified Date:
2009-08
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 high-dose sequential chemotherapy as adjuvant therapy in treating patients with stage II or stage III breast cancer who have four or more positive axillary lymph nodes
PURPOSE Phase II trial to study the effectiveness of high-dose sequential chemotherapy as adjuvant therapy in treating patients with stage II or stage III breast cancer who have four or more positive axillary lymph nodes
Detailed Description:
OBJECTIVES I Evaluate the efficacy of dose intensive sequential adjuvant chemotherapy with doxorubicin paclitaxel and cyclophosphamide in patients with stage IIIII resected breast cancer II Evaluate the toxicity of this regimen in these patients
OUTLINE All patients receive sequential chemotherapy regimens consisting of 3 courses each of doxorubicin paclitaxel and cyclophosphamide on a schedule of one course every 14 days Following completion of chemotherapy patients who underwent breast conservation surgery receive radiotherapy Mastectomy patients with 10 or more positive nodes or with T3-4 tumors are also eligible for delayed radiotherapy Patients who are hormone receptor positive or whose receptor status is unknown are treated with oral tamoxifen for 5 years beginning after completion of all other therapy Patients are followed every 3 months for 2 years every 6 months for 3 years then yearly
PROJECTED ACCRUAL At total of 90 patients will be entered
OUTLINE All patients receive sequential chemotherapy regimens consisting of 3 courses each of doxorubicin paclitaxel and cyclophosphamide on a schedule of one course every 14 days Following completion of chemotherapy patients who underwent breast conservation surgery receive radiotherapy Mastectomy patients with 10 or more positive nodes or with T3-4 tumors are also eligible for delayed radiotherapy Patients who are hormone receptor positive or whose receptor status is unknown are treated with oral tamoxifen for 5 years beginning after completion of all other therapy Patients are followed every 3 months for 2 years every 6 months for 3 years then yearly
PROJECTED ACCRUAL At total of 90 patients will be entered
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-V95-0720 | None | None | None |
| YALE-HIC-7374 | None | None | None |