Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00255788
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2005-11-18
Brief Title:
Everolimus in Treating Patients WIth Recurrent or Metastatic Breast Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With RecurrentMetastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-04
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 Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor
PURPOSE This randomized phase II trial is studying two different schedules of everolimus to see how well they work in treating patients with recurrent or metastatic breast cancer
PURPOSE This randomized phase II trial is studying two different schedules of everolimus to see how well they work in treating patients with recurrent or metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of 2 different treatment schedules of everolimus in terms of clinicalradiological response and early progression in patients with recurrent or metastatic breast cancer
Secondary
Determine the time to progression and response duration in patients treated with these regimens
Determine the toxic effects of these regimens in these patients
Correlate molecular markers of mTOR activity in tumor tissue with objective tumor response in patients treated with these regimens
OUTLINE This is a randomized open label multicenter study Patients are stratified according to presence of visceral metastases yes vs no and prior chemotherapy regimens for recurrent disease 0 vs 1 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral everolimus once daily on days 1-28
Arm II Patients receive oral everolimus on days 1 8 15 and 22 In both arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 4 weeks and then periodically until disease progression
PROJECTED ACCRUAL A total of 60 patients 30 per treatment arm will be accrued for this study
Primary
Determine the efficacy of 2 different treatment schedules of everolimus in terms of clinicalradiological response and early progression in patients with recurrent or metastatic breast cancer
Secondary
Determine the time to progression and response duration in patients treated with these regimens
Determine the toxic effects of these regimens in these patients
Correlate molecular markers of mTOR activity in tumor tissue with objective tumor response in patients treated with these regimens
OUTLINE This is a randomized open label multicenter study Patients are stratified according to presence of visceral metastases yes vs no and prior chemotherapy regimens for recurrent disease 0 vs 1 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral everolimus once daily on days 1-28
Arm II Patients receive oral everolimus on days 1 8 15 and 22 In both arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 4 weeks and then periodically until disease progression
PROJECTED ACCRUAL A total of 60 patients 30 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| CAN-NCIC-IND163 | OTHER | None | None |
| NOVARTIS-CAN-NCIC-IND163 | OTHER | None | None |
| CDR0000450849 | OTHER | PDQ | None |