Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003032
Status:
COMPLETED
Last Update Posted:
2020-04-01
First Post:
1999-11-01
Brief Title:
High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Randomized Trial of High-Dose Chemotherapy and Autologous Stem Cell Therapy Versus Standard Therapy in Women With Metastatic Breast Cancer Who Have Responded to Anthracycline or Taxane-Based Induction Chemotherapy
Status:
COMPLETED
Status Verified Date:
2020-03
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 whether standard therapy is more effective than high dose chemotherapy for breast cancer
PURPOSE Randomized phase III trial to compare the effectiveness of high dose chemotherapy plus peripheral stem cell transplantation with that of standard therapy in treating women with metastatic or recurrent breast cancer that has responded to previous chemotherapy
PURPOSE Randomized phase III trial to compare the effectiveness of high dose chemotherapy plus peripheral stem cell transplantation with that of standard therapy in treating women with metastatic or recurrent breast cancer that has responded to previous chemotherapy
Detailed Description:
OBJECTIVES I Compare the overall survival of women with metastatic breast cancer receiving either high dose chemotherapy and autologous peripheral blood stem cell therapy or standard therapy following response to anthracycline or taxane based chemotherapy II Evaluate the final response rates between the two treatment arms III Compare the two treatment arms with respect to toxic effects IV Assess health related quality of life in both groups of patients
OUTLINE This is a multicenter nonblinded randomized study Patients are stratified by type of induction chemotherapy response status presence of visceral disease receptor status and tamoxifen therapy ER negative ER positive no prior tamoxifen ER positive failed tamoxifen receptor status unknown A quality of life questionnaire is given to each patient before and during treatment then every 3 months thereafter Patients are assessed following 4 courses of induction chemotherapy Those achieving complete remission partial remission or who have no evaluable disease are randomized to either treatment arm I or arm II For treatment arm I stem cells are mobilized by chemotherapy courses 5 and 6 plus filgrastim G-CSF or with G-CSF alone Following course 6 patients receive daily doses of IV cyclophosphamide mitoxantrone and carboplatin on days -6 to -3 followed by stem cell infusion on day 0 and G-CSF from day 5 In arm II patients receive two further courses of standard induction chemotherapy followed by maintenance chemotherapy at the discretion of the treating physician All patients with positive receptor status or unknown receptor status who have not previously failed tamoxifen therapy receive tamoxifen at the completion of post peripheral stem cell transplant arm I or induction chemotherapy arm II Following hematologic recovery from high dose chemotherapy patients in arm I with limited disease receive consolidated radiation and may also receive surgical treatment for limited disease In arm II patients who completed courses 5 and 6 of induction chemotherapy receive involved field radiation at the physicians discretion Patients from arm II may also receive surgical treatment following protocol therapy at the physicians discretion Patients are followed every 3 months until death
PROJECTED ACCRUAL This study will accrue approximately 50 patients per year for a total of 192 patients in 38 years
OUTLINE This is a multicenter nonblinded randomized study Patients are stratified by type of induction chemotherapy response status presence of visceral disease receptor status and tamoxifen therapy ER negative ER positive no prior tamoxifen ER positive failed tamoxifen receptor status unknown A quality of life questionnaire is given to each patient before and during treatment then every 3 months thereafter Patients are assessed following 4 courses of induction chemotherapy Those achieving complete remission partial remission or who have no evaluable disease are randomized to either treatment arm I or arm II For treatment arm I stem cells are mobilized by chemotherapy courses 5 and 6 plus filgrastim G-CSF or with G-CSF alone Following course 6 patients receive daily doses of IV cyclophosphamide mitoxantrone and carboplatin on days -6 to -3 followed by stem cell infusion on day 0 and G-CSF from day 5 In arm II patients receive two further courses of standard induction chemotherapy followed by maintenance chemotherapy at the discretion of the treating physician All patients with positive receptor status or unknown receptor status who have not previously failed tamoxifen therapy receive tamoxifen at the completion of post peripheral stem cell transplant arm I or induction chemotherapy arm II Following hematologic recovery from high dose chemotherapy patients in arm I with limited disease receive consolidated radiation and may also receive surgical treatment for limited disease In arm II patients who completed courses 5 and 6 of induction chemotherapy receive involved field radiation at the physicians discretion Patients from arm II may also receive surgical treatment following protocol therapy at the physicians discretion Patients are followed every 3 months until death
PROJECTED ACCRUAL This study will accrue approximately 50 patients per year for a total of 192 patients in 38 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000065634 | OTHER | PDQ | None |
| CAN-NCIC-MA16 | None | None | None |