Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003972
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage II or Stage IIIA Breast Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase III Study of High-Dose Chemotherapy Using Busulfan Melphalan and Thiotepa Versus CyclophosphamideThiotepa Carboplatin Followed by Autologous Stem Cell Transplantation in Patients With High-Risk Primary Stage II or III Non-Inflammatory Breast Cancer
Status:
COMPLETED
Status Verified Date:
2010-03
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 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 which regimen of combination chemotherapy is more effective for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy followed by peripheral stem cell transplantation in treating patients who have stage II or stage IIIA breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy followed by peripheral stem cell transplantation in treating patients who have stage II or stage IIIA breast cancer
Detailed Description:
OBJECTIVES I Compare early mortality survival and disease free survival in patients with node positive stage II or IIIA breast cancer treated with busulfan melphalan and thiotepa versus cyclophosphamide thiotepa and carboplatin followed by autologous peripheral blood stem cell transplantation II Compare the toxicity of these 2 regimens in this patient population
OUTLINE This is a randomized study Patients are stratified according to stage of disease stage II vs stage IIIA lymph node status at least 10 positive nodes vs less than 10 positive nodes and hormone receptor status estrogen receptor positive or progesterone receptor positive vs estrogen receptor negative or progesterone receptor negative All patients initially receive mobilization chemotherapy with cyclophosphamide IV over 1-2 hours on day 1 and paclitaxel IV over 4 hours on day 2 Beginning on day 4 patients receive filgrastim G-CSF or sargramostim GM-CSF subcutaneously each day until the final day of leukapheresis When blood counts recover peripheral blood stem cells PBSC are harvested Patients are randomized to 1 of 2 high dose chemotherapy regimens 28-45 days after the last dose of mobilization chemotherapy Arm I Patients receive oral busulfan every 6 hours on days -8 to -6 melphalan IV over 30-60 minutes on days -5 and -4 and thiotepa IV over 2 hours on days -3 and -2 PBSC are reinfused on day 0 Arm II Patients receive cyclophosphamide thiotepa and carboplatin by continuous IV infusion over 24 hours on days -7 to -4 PBSC are reinfused on day 0 Beginning 4-6 weeks after the last dose of chemotherapy patients in both arms receive local radiotherapy 5 days each week for 5 weeks Patients also receive oral tamoxifen or equivalent antiestrogen therapy daily for 5 years if they are estrogen or progesterone receptor positive postmenopausal or age 50 and over and perimenopausal Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 280 patients 140 per treatment arm will be accrued for this study over 3 years
OUTLINE This is a randomized study Patients are stratified according to stage of disease stage II vs stage IIIA lymph node status at least 10 positive nodes vs less than 10 positive nodes and hormone receptor status estrogen receptor positive or progesterone receptor positive vs estrogen receptor negative or progesterone receptor negative All patients initially receive mobilization chemotherapy with cyclophosphamide IV over 1-2 hours on day 1 and paclitaxel IV over 4 hours on day 2 Beginning on day 4 patients receive filgrastim G-CSF or sargramostim GM-CSF subcutaneously each day until the final day of leukapheresis When blood counts recover peripheral blood stem cells PBSC are harvested Patients are randomized to 1 of 2 high dose chemotherapy regimens 28-45 days after the last dose of mobilization chemotherapy Arm I Patients receive oral busulfan every 6 hours on days -8 to -6 melphalan IV over 30-60 minutes on days -5 and -4 and thiotepa IV over 2 hours on days -3 and -2 PBSC are reinfused on day 0 Arm II Patients receive cyclophosphamide thiotepa and carboplatin by continuous IV infusion over 24 hours on days -7 to -4 PBSC are reinfused on day 0 Beginning 4-6 weeks after the last dose of chemotherapy patients in both arms receive local radiotherapy 5 days each week for 5 weeks Patients also receive oral tamoxifen or equivalent antiestrogen therapy daily for 5 years if they are estrogen or progesterone receptor positive postmenopausal or age 50 and over and perimenopausal Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 280 patients 140 per treatment arm will be accrued for this study over 3 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 |
|---|---|---|---|
| CDR0000067175 | REGISTRY | PDQ | None |
| FHCRC-131600 | None | None | None |
| PSOC-1604 | None | None | None |
| NCI-G99-1552 | None | None | None |