Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002755
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Standard Chemotherapy Compared With High-Dose Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
Sponsor:
Scottish Cancer Therapy Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PROSPECTIVE RANDOMISED EVALUATION OF HIGH-INTENSITY CHEMOTHERAPY WITH PERIPHERAL BLOOD PROGENITOR SUPPORT IN PATIENTS WITH HIGH RISK BREAST CANCER
Status:
COMPLETED
Status Verified Date:
2007-05
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 Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more tumor cells It is not yet known which treatment regimen is more effective for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of standard cyclophosphamide methotrexate and fluorouracil with that of high-dose combination chemotherapy plus peripheral stem cell transplantation in treating women who have stage II or stage IIIA breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of standard cyclophosphamide methotrexate and fluorouracil with that of high-dose combination chemotherapy plus peripheral stem cell transplantation in treating women who have stage II or stage IIIA breast cancer
Detailed Description:
OBJECTIVES I Compare the efficacy of high dose cyclophosphamide and thiotepa with peripheral blood stem cell support vs conventional cyclophosphamide methotrexate and fluorouracil CMF both following doxorubicin induction in women with high risk breast cancer
OUTLINE This is a randomized multicenter study Patients are stratified by the number of positive axillary nodes 4-9 vs at least 10 and by center Patients are randomized to one of two treatment arms Arm I Patients receive induction therapy consisting of doxorubicin IV every 3 weeks for 4 courses followed by consolidation therapy consisting of cyclophosphamide IV methotrexate IV and fluorouracil IV every 3 weeks for 8 courses At week 4 of consolidation therapy patients receive radiotherapy to the breast chest wall and axilla over 3-5 weeks or as appropriate Following recovery from consolidation therapy patients receive maintenance therapy consisting of oral tamoxifen daily for 5 years Arm II Patients receive induction therapy as in arm I followed by consolidation therapy consisting of stem cell mobilization with high dose cyclophosphamide IV over 2 hours and filgrastim G-CSF subcutaneously beginning 24 hours after cyclophosphamide and continuing until blood counts recover At 13-28 days following peripheral blood stem cell PBSC collection andor autologous bone marrow collection patients undergo chemoablation consisting of thiotepa IV and cyclophosphamide IV continuously over 4 days followed 72 hours later by PBSC infusion with or without autologous bone marrow Following hematologic recovery patients receive radiotherapy and maintenance therapy as in arm I Patients are followed every 6 months for 2 years then annually
PROJECTED ACCRUAL More than 600 patients will be accrued for this study over 5 years
OUTLINE This is a randomized multicenter study Patients are stratified by the number of positive axillary nodes 4-9 vs at least 10 and by center Patients are randomized to one of two treatment arms Arm I Patients receive induction therapy consisting of doxorubicin IV every 3 weeks for 4 courses followed by consolidation therapy consisting of cyclophosphamide IV methotrexate IV and fluorouracil IV every 3 weeks for 8 courses At week 4 of consolidation therapy patients receive radiotherapy to the breast chest wall and axilla over 3-5 weeks or as appropriate Following recovery from consolidation therapy patients receive maintenance therapy consisting of oral tamoxifen daily for 5 years Arm II Patients receive induction therapy as in arm I followed by consolidation therapy consisting of stem cell mobilization with high dose cyclophosphamide IV over 2 hours and filgrastim G-CSF subcutaneously beginning 24 hours after cyclophosphamide and continuing until blood counts recover At 13-28 days following peripheral blood stem cell PBSC collection andor autologous bone marrow collection patients undergo chemoablation consisting of thiotepa IV and cyclophosphamide IV continuously over 4 days followed 72 hours later by PBSC infusion with or without autologous bone marrow Following hematologic recovery patients receive radiotherapy and maintenance therapy as in arm I Patients are followed every 6 months for 2 years then annually
PROJECTED ACCRUAL More than 600 patients will be accrued for this study over 5 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 |
|---|---|---|---|
| EU-95048 | None | None | None |
| SCTN-BR9405 | None | None | None |