Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003680
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Brief Title:
Standard Chemotherapy Compared With High-Dose Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Women With Advanced or Inflammatory Breast Cancer
Sponsor:
Scottish Cancer Therapy Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomised Comparative Trial of Highly Intensive Chemotherapy With Stem Cell Support vs Relatively Intensive Chemotherapy CMF 8 Cycles in Breast Cancer Patients Node Positive Surgery Having Received Primary Medical Therapy With an Anthracycline Regimen
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 chemotherapy with 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 whether high-dose chemotherapy plus peripheral stem cell transplantation is more effective than standard chemotherapy for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of standard chemotherapy with that of high-dose chemotherapy plus peripheral stem cell transplantation in treating women who have advanced breast cancer or inflammatory breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of standard chemotherapy with that of high-dose chemotherapy plus peripheral stem cell transplantation in treating women who have advanced breast cancer or inflammatory breast cancer
Detailed Description:
OBJECTIVES I Compare the overall survival in locally advanced inflammatory or operable large primary breast cancer greater than 3 cm patients with positive axillary lymph nodes at surgery following primary chemotherapy receiving either conventional chemotherapy or high dose chemotherapy as adjuvant therapy II Compare the relapse-free survival and quality of life in these patients receiving this therapy
OUTLINE This is a randomized multicenter open label study Patients are stratified by study center and number of positive axillary lymph nodes at surgery Patients are randomized to receive conventional or high dose adjuvant chemotherapy Arm I Patients receive conventional chemotherapy consisting of cyclophosphamide methotrexate and fluorouracil IV administered once every 3 weeks for 8 courses Arm II Patients receive high dose chemotherapy Cyclophosphamide IV is administered on day 1 Patients undergo peripheral blood progenitor cell PBPC collection then receive cyclophosphamide and thiotepa IV for 4 days 13-28 days after PBPC collection Peripheral blood progenitor cells are then reinfused Patients undergo radiotherapy during or after chemotherapy and receive oral tamoxifen for 5 years beginning at the same time as radiotherapy Estrogen receptor negative patients may receive tamoxifen at the discretion of the treating physician Quality of life is assessed before chemotherapy then at 6 12 and 24 months Patients are followed at 12 18 and 24 months then annually for 5 years or until death
PROJECTED ACCRUAL This study will accrue approximately 300 patients
OUTLINE This is a randomized multicenter open label study Patients are stratified by study center and number of positive axillary lymph nodes at surgery Patients are randomized to receive conventional or high dose adjuvant chemotherapy Arm I Patients receive conventional chemotherapy consisting of cyclophosphamide methotrexate and fluorouracil IV administered once every 3 weeks for 8 courses Arm II Patients receive high dose chemotherapy Cyclophosphamide IV is administered on day 1 Patients undergo peripheral blood progenitor cell PBPC collection then receive cyclophosphamide and thiotepa IV for 4 days 13-28 days after PBPC collection Peripheral blood progenitor cells are then reinfused Patients undergo radiotherapy during or after chemotherapy and receive oral tamoxifen for 5 years beginning at the same time as radiotherapy Estrogen receptor negative patients may receive tamoxifen at the discretion of the treating physician Quality of life is assessed before chemotherapy then at 6 12 and 24 months Patients are followed at 12 18 and 24 months then annually for 5 years or until death
PROJECTED ACCRUAL This study will accrue approximately 300 patients
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-98054 | None | None | None |
| SCTN-BR9810 | None | None | None |