Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00296010
Status:
TERMINATED
Last Update Posted:
2021-02-23
First Post:
2006-02-23
Brief Title:
Liposomal Doxorubicin Compared With Observation or Cyclophosphamide and Methotrexate in Treating Older Women Who Have Undergone Surgery for Breast Cancer
Sponsor:
ETOP IBCSG Partners Foundation
Organization:
ETOP IBCSG Partners Foundation
Study Overview
Official Title:
Phase III Trial Evaluating the Role of Adjuvant Pegylated Liposomal Doxorubicin PLD Caelyx Doxil for Women Age 66 Years or Older With Endocrine Nonresponsive Breast Cancer Who Are Not Suitable for Being Offered a Standard Chemotherapy Regimen
Status:
TERMINATED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Accrual rate was too low
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASA
Brief Summary:
RATIONALE Drugs used in chemotherapy such as methotrexate cyclophosphamide and liposomal doxorubicin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving chemotherapy after surgery may kill any tumor cells that remain after surgery It is not yet known whether giving liposomal doxorubicin after surgery is more effective than observation or cyclophosphamide and methotrexate in treating breast cancer
PURPOSE This randomized phase III trial is studying liposomal doxorubicin to see how well it works compared with observation or cyclophosphamide and methotrexate in treating older women who have undergone surgery for breast cancer
PURPOSE This randomized phase III trial is studying liposomal doxorubicin to see how well it works compared with observation or cyclophosphamide and methotrexate in treating older women who have undergone surgery for breast cancer
Detailed Description:
OBJECTIVES
Primary
Compare the breast cancer-free interval in elderly women with resectable hormone receptor-negative breast cancer treated with pegylated doxorubicin hydrochloride liposome PDL vs observation or PDL vs cyclophosphamide and methotrexate
Secondary
Compare the tolerability of these regimens in these patients
Compare the safety and toxic effects of these regimens in these patients
Compare the overall and progression-free survival of patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Compare the sites of failure in patients treated with these regimens
Compare the competing causes of death in patients treated with these regimens
Compare the rate of second non-breast malignancy in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center Patients are assigned based on patient preference to 1 of 2 treatment groups
Group 1 Patients are randomized to 1 of 2 arms arms I and II
Arm I Patients receive pegylated doxorubicin hydrochloride liposome PDL IV over 1 hour on day 1 Treatment repeats every 2 weeks for 8 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo observation only
Group 2 Patients are randomized to 1 of 2 treatment arms arms III and IV
Arm III Patients receive PDL as in arm I
Arm IV Patients receive oral cyclophosphamide once daily on days 1-7 and oral methotrexate twice daily on days 1 and 4 Treatment repeats every week for 16 courses in the absence of disease progression or unacceptable toxicity
All patients may undergo radiotherapy according to institutional standards either during surgery or after the completion of chemotherapy
Quality of life is assessed at baseline and at 3 6 and 12 months
After completion of study treatment patients are followed periodically for 1 year
PROJECTED ACCRUAL A total of 1296 patients will be accrued for this study
Primary
Compare the breast cancer-free interval in elderly women with resectable hormone receptor-negative breast cancer treated with pegylated doxorubicin hydrochloride liposome PDL vs observation or PDL vs cyclophosphamide and methotrexate
Secondary
Compare the tolerability of these regimens in these patients
Compare the safety and toxic effects of these regimens in these patients
Compare the overall and progression-free survival of patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Compare the sites of failure in patients treated with these regimens
Compare the competing causes of death in patients treated with these regimens
Compare the rate of second non-breast malignancy in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center Patients are assigned based on patient preference to 1 of 2 treatment groups
Group 1 Patients are randomized to 1 of 2 arms arms I and II
Arm I Patients receive pegylated doxorubicin hydrochloride liposome PDL IV over 1 hour on day 1 Treatment repeats every 2 weeks for 8 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo observation only
Group 2 Patients are randomized to 1 of 2 treatment arms arms III and IV
Arm III Patients receive PDL as in arm I
Arm IV Patients receive oral cyclophosphamide once daily on days 1-7 and oral methotrexate twice daily on days 1 and 4 Treatment repeats every week for 16 courses in the absence of disease progression or unacceptable toxicity
All patients may undergo radiotherapy according to institutional standards either during surgery or after the completion of chemotherapy
Quality of life is assessed at baseline and at 3 6 and 12 months
After completion of study treatment patients are followed periodically for 1 year
PROJECTED ACCRUAL A total of 1296 patients will be accrued for this 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-205112 | Other Identifier | Breast International Group | None |
| IBCSG-32-05 | OTHER | None | None |
| BIG-CASA | OTHER | None | None |
| 2005-003434-18 | EUDRACT_NUMBER | None | None |
| BIG-1-05 | OTHER | None | None |