Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002772
Status:
TERMINATED
Last Update Posted:
2013-01-24
First Post:
1999-11-01
Brief Title:
S9623 Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Comparison of Intensive Sequential Chemotherapy Using Doxorubicin Plus Paclitaxel Plus Cyclophosphamide With High Dose Chemotherapy and Autologous Hematopoietic Progenitor Cell Support for Primary Breast Cancer in Women With 4-9 Involved Axillary Lymph Nodes
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual
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 the doctor to give higher doses of chemotherapy drugs and kill more tumor cells It is not yet known which regimen of chemotherapy followed by peripheral stem cell transplantation is more effective for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating women who have undergone surgery for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating women who have undergone surgery for breast cancer
Detailed Description:
OBJECTIVES I Compare disease free survival and overall survival in women with operable breast cancer and at least 4 positive axillary lymph nodes treated with intensive sequential chemotherapy with doxorubicin paclitaxel and cyclophosphamide versus standard dose doxorubicin and cyclophosphamide followed by high dose STAMP I cyclophosphamide cisplatin and carmustine or STAMP V cyclophosphamide carboplatin and thiotepa and autologous stem cell rescue II Compare the toxic effects of these regimens in this patient population III Measure the breast cancer cell content of the peripheral blood progenitor cell PBPC fractions from patients randomized to the PBPC supported arm and correlate the results with the disease free survival survival and pattern of relapse in these patients
OUTLINE This is a randomized multicenter study Patients are stratified by center primary treatment mastectomy alone vs mastectomy plus radiotherapy following chemotherapy vs breast conserving surgery plus radiotherapy following chemotherapy menopausal status premenopausal vs postmenopausal estrogen andor progesterone receptor status positive vs negative vs unknown N2 disease yes vs no T3 disease yes vs no myeloablative chemotherapy regimen STAMP I vs STAMP V and source of progenitor cells marrow vs peripheral blood vs both Patients are randomized to 1 of 2 treatment arms Arm I Patients receive doxorubicin IV over 1 hour on days 1 15 and 29 paclitaxel IV over 24 hours on days 43 57 and 71 and cyclophosphamide IV over 1 hour on days 85 99 and 113 Patients receive filgrastim G-CSF subcutaneously on days 3-10 17-24 31-38 45-52 59-66 73-80 87-94 101-108 and 115-122 Arm II Mobilization chemotherapy Patients receive doxorubicin IV over 1 hour and cyclophosphamide IV over 1 hour on days 1 22 43 and 64 Harvest Patients undergo harvest of autologous bone marrow andor peripheral blood stem cells PBSC Patients who undergo harvest of PBSC alone do not receive mobilization chemotherapy but receive hematopoietic growth factors prior to harvest High dose myeloablative chemotherapy Patients receive STAMP I OR STAMP V STAMP I Patients receive cyclophosphamide IV over 1 hour and cisplatin IV over 24 hours on days -6 to -4 and carmustine IV over 2 hour on day -3 STAMP V Patients receive cyclophosphamide IV over 24 hours carboplatin IV over 24 hours and thiotepa IV over 24 hours on days -7 to -4 Transplantation Autologous bone marrow andor PBSC are reinfused on day 0 Both arms Patients who are postmenopausal or who have hormone receptor positive disease receive oral tamoxifen daily beginning 4 weeks after the completion of chemotherapy and continuing for 5 years Patients who underwent breast conserving surgery receive locoregional radiotherapy 5 days a week for 45-55 weeks beginning 4-6 weeks after the completion of chemotherapy Patients who underwent modified radical mastectomy may receive locoregional radiotherapy 5 days a week for 5 weeks at the discretion of their physician Patients are followed every 4 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 1000 patients 500 per arm will be accrued for this study within 5 years
OUTLINE This is a randomized multicenter study Patients are stratified by center primary treatment mastectomy alone vs mastectomy plus radiotherapy following chemotherapy vs breast conserving surgery plus radiotherapy following chemotherapy menopausal status premenopausal vs postmenopausal estrogen andor progesterone receptor status positive vs negative vs unknown N2 disease yes vs no T3 disease yes vs no myeloablative chemotherapy regimen STAMP I vs STAMP V and source of progenitor cells marrow vs peripheral blood vs both Patients are randomized to 1 of 2 treatment arms Arm I Patients receive doxorubicin IV over 1 hour on days 1 15 and 29 paclitaxel IV over 24 hours on days 43 57 and 71 and cyclophosphamide IV over 1 hour on days 85 99 and 113 Patients receive filgrastim G-CSF subcutaneously on days 3-10 17-24 31-38 45-52 59-66 73-80 87-94 101-108 and 115-122 Arm II Mobilization chemotherapy Patients receive doxorubicin IV over 1 hour and cyclophosphamide IV over 1 hour on days 1 22 43 and 64 Harvest Patients undergo harvest of autologous bone marrow andor peripheral blood stem cells PBSC Patients who undergo harvest of PBSC alone do not receive mobilization chemotherapy but receive hematopoietic growth factors prior to harvest High dose myeloablative chemotherapy Patients receive STAMP I OR STAMP V STAMP I Patients receive cyclophosphamide IV over 1 hour and cisplatin IV over 24 hours on days -6 to -4 and carmustine IV over 2 hour on day -3 STAMP V Patients receive cyclophosphamide IV over 24 hours carboplatin IV over 24 hours and thiotepa IV over 24 hours on days -7 to -4 Transplantation Autologous bone marrow andor PBSC are reinfused on day 0 Both arms Patients who are postmenopausal or who have hormone receptor positive disease receive oral tamoxifen daily beginning 4 weeks after the completion of chemotherapy and continuing for 5 years Patients who underwent breast conserving surgery receive locoregional radiotherapy 5 days a week for 45-55 weeks beginning 4-6 weeks after the completion of chemotherapy Patients who underwent modified radical mastectomy may receive locoregional radiotherapy 5 days a week for 5 weeks at the discretion of their physician Patients are followed every 4 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 1000 patients 500 per arm will be accrued for this study within 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S9623 | OTHER | None | None |