Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003010
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
1999-11-01
Brief Title:
Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Randomized Phase III Trial of Marimastat Versus Placebo in Patients With Metastatic Breast Cancer Who Have Responding or Stable Disease After Induction Chemotherapy
Status:
COMPLETED
Status Verified Date:
2023-06
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 Marimastat may stop the growth of breast cancer by stopping blood flow to the tumor It is not known whether chemotherapy is more effective with or without marimastat for breast cancer
PURPOSE Randomized double-blinded phase III trial to compare the effectiveness of marimastat with that of no further therapy in treating women who have metastatic breast cancer that is responding or stable after chemotherapy
PURPOSE Randomized double-blinded phase III trial to compare the effectiveness of marimastat with that of no further therapy in treating women who have metastatic breast cancer that is responding or stable after chemotherapy
Detailed Description:
OBJECTIVES I Determine whether marimastat prolongs progression-free survival in women with metastatic breast cancer who have responding or stable disease after receiving standard systemic chemotherapy II Determine the toxic effects of marimastat compared with placebo in patients with metastatic breast cancer who have responding or stable disease after receiving standard systemic chemotherapy III Determine whether there is an association between trough marimastat concentration and time to disease progression and toxicity
OUTLINE This is a randomized double blind placebo controlled study Patients are stratified by the number of involved disease sites at study entry prior chemotherapy for metastases osseous disease only at study entry and bisphosphonate therapy at study entry and concurrent hormonal therapy yes vs no Patients are randomized into two groups Patients take either marimastat or placebo one capsule orally twice a day approximately every 12 hours ie during or after breakfast and dinner The drug or placebo is given until the development of progressive disease or prohibitive toxicity
PROJECTED ACCRUAL A total of 334 patients will be accrued for this study over 2 years
OUTLINE This is a randomized double blind placebo controlled study Patients are stratified by the number of involved disease sites at study entry prior chemotherapy for metastases osseous disease only at study entry and bisphosphonate therapy at study entry and concurrent hormonal therapy yes vs no Patients are randomized into two groups Patients take either marimastat or placebo one capsule orally twice a day approximately every 12 hours ie during or after breakfast and dinner The drug or placebo is given until the development of progressive disease or prohibitive toxicity
PROJECTED ACCRUAL A total of 334 patients will be accrued for this study over 2 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 |
|---|---|---|---|
| NCCTG-E2196 | None | None | None |
| E2196 | None | None | None |