Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002870
Status:
COMPLETED
Last Update Posted:
2014-12-16
First Post:
1999-11-01
Brief Title:
High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Locally Recurrent or Metastatic Breast Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
A RANDOMIZED MULTI-CENTRE PHASE III TRIAL TO EVALUATE THE ROLE OF INTENSIFIED THERAPY WITH AUTOLOGOUS TRANSPLANTATION OF HEMATOPOIETIC STEM CELLS IN ADVANCED OR METASTATIC BREAST CANCER RESPONDING TO INDUCTION CHEMOTHERAPY
Status:
COMPLETED
Status Verified Date:
2014-12
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 to kill more tumor cells It is not yet known if high dose chemotherapy plus peripheral stem cell transplantation is more effective than standard therapy 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 who have locally recurrent or metastatic 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 who have locally recurrent or metastatic breast cancer
Detailed Description:
OBJECTIVES I Evaluate the effect on 3-year survival of intensive chemotherapy with cyclophosphamidethiotepa with peripheral blood stem cell rescue in women with locally recurrent or metastatic breast cancer who respond to induction therapy with epirubicinfluorouracilcyclophosphamide II Evaluate the effects of this intensive treatment on patient quality of life III Evaluate tumor response and progression-free survival after intensification
OUTLINE This is a randomized study Patients are stratified by clinicaltherapeutic hormone sensitivity and participating institution All patients receive induction therapy with epirubicin fluorouracil and cyclophosphamide FEC 100 every 3 weeks for up to 4 courses with response evaluated after at least 2 courses Patients with a complete response or at least a 50 partial response are randomized either to no further therapy or to receive intensification chemotherapy Patients randomized to intensification undergo peripheral blood stem cell PBSC harvest with G-CSF mobilization after the third or fourth induction course Three to 6 weeks after induction patients receive intensification chemotherapy with cyclophosphamidethiotepa followed by PBSC Post-transplant G-CSF is given for hematopoietic support No concurrent hormonal therapy is permitted during induction local irradiation of multifocal tumors is allowed provided response is still evaluable Local therapy excision of single metastasis radiotherapy to metastatic site is permitted after completion of protocol therapy Treatment of relapsed disease is at the discretion of the investigator Patients are followed every 3 months for 3 years or until relapse then every 6 months
PROJECTED ACCRUAL A total of 180 patients will be accrued over 3 years in this multicenter study
OUTLINE This is a randomized study Patients are stratified by clinicaltherapeutic hormone sensitivity and participating institution All patients receive induction therapy with epirubicin fluorouracil and cyclophosphamide FEC 100 every 3 weeks for up to 4 courses with response evaluated after at least 2 courses Patients with a complete response or at least a 50 partial response are randomized either to no further therapy or to receive intensification chemotherapy Patients randomized to intensification undergo peripheral blood stem cell PBSC harvest with G-CSF mobilization after the third or fourth induction course Three to 6 weeks after induction patients receive intensification chemotherapy with cyclophosphamidethiotepa followed by PBSC Post-transplant G-CSF is given for hematopoietic support No concurrent hormonal therapy is permitted during induction local irradiation of multifocal tumors is allowed provided response is still evaluable Local therapy excision of single metastasis radiotherapy to metastatic site is permitted after completion of protocol therapy Treatment of relapsed disease is at the discretion of the investigator Patients are followed every 3 months for 3 years or until relapse then every 6 months
PROJECTED ACCRUAL A total of 180 patients will be accrued over 3 years in this multicenter study
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-96032 | None | None | None |
| FRE-FNCLCC-PEGASE03 | None | None | None |