Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012025
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2001-03-03
Brief Title:
ICI 182780 in Treating Women With Metastatic Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial Of Fulvestrant Faslodex In Women With Metastatic Breast Cancer And Failure on Aromatase Inhibitor Therapy
Status:
COMPLETED
Status Verified Date:
2016-07
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 Estrogen can stimulate the growth of breast cancer cells Hormone therapy using ICI 182780 may fight breast cancer by blocking the activity of estrogen in the tumor cells
PURPOSE Phase II trial to study the effectiveness of ICI 182780 in treating patients who have metastatic breast cancer that has not responded to previous hormone therapy
PURPOSE Phase II trial to study the effectiveness of ICI 182780 in treating patients who have metastatic breast cancer that has not responded to previous hormone therapy
Detailed Description:
OBJECTIVES
Determine the complete and partial objective response rate and duration of response in women with metastatic breast cancer who have failed aromatase inhibitor therapy treated with fulvestrant
Determine the time to disease progression and overall survival of women treated with this drug
Determine the toxicity of this drug in these women
OUTLINE Patients receive fulvestrant intramuscularly on day 1 Courses repeat approximately every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 5 years or until disease progression After disease progression patients are followed every 3 months for 2 years and then every 6 months for 3 years
Determine the complete and partial objective response rate and duration of response in women with metastatic breast cancer who have failed aromatase inhibitor therapy treated with fulvestrant
Determine the time to disease progression and overall survival of women treated with this drug
Determine the toxicity of this drug in these women
OUTLINE Patients receive fulvestrant intramuscularly on day 1 Courses repeat approximately every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 5 years or until disease progression After disease progression patients are followed every 3 months for 2 years and then every 6 months for 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 |
|---|---|---|---|
| CDR0000068473 | REGISTRY | PDQ Physician Data Query | None |