Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338728
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2006-06-16
Brief Title:
Letrozole and Imatinib Mesylate in Treating Postmenopausal Participants With Estrogen or Progesterone Positive Metastatic Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Letrozole Femara Plus Imatinib Mesylate Gleevec for Postmenopausal Patients With ER andor PR Positive Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies the side effects and how well letrozole and imatinib mesylate work in treating postmenopausal participants with estrogen or progesterone positive breast cancer that has spread to other places in the body Letrozole is an antihormonal drug used in the standard treatment of hormonal sensitive breast cancer Imatinib mesylate is a drug that binds to certain proteins on the tumor cells and prevents them from further growth Imatinib mesylate is thought to prevent the potential resistance to letrozole which may make the letrozole more effective Giving letrozole and imatinib mesylate may work better in treating participants with breast cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine the efficacy of letrozole plus imatinib mesylate in patients with estrogen receptor ER and or progesterone receptor PgR positive metastatic breast cancer
II To determine the safety and tolerability of letrozole plus imatinib mesylate in patients with metastatic breast cancer
III To determine the time to disease progression and overall survival in patients with metastatic breast cancer who are treated with letrozole plus imatinib mesylate
OUTLINE
Participants receive imatinib mesylate orally PO twice daily BID and letrozole PO once daily QD for 8 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment participants are followed up at 1 and 4 weeks and at 2 4 6 9 and 12 months
I To determine the efficacy of letrozole plus imatinib mesylate in patients with estrogen receptor ER and or progesterone receptor PgR positive metastatic breast cancer
II To determine the safety and tolerability of letrozole plus imatinib mesylate in patients with metastatic breast cancer
III To determine the time to disease progression and overall survival in patients with metastatic breast cancer who are treated with letrozole plus imatinib mesylate
OUTLINE
Participants receive imatinib mesylate orally PO twice daily BID and letrozole PO once daily QD for 8 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment participants are followed up at 1 and 4 weeks and at 2 4 6 9 and 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| NCI-2018-01843 | REGISTRY | None | None |
| 2003-0384 | OTHER | None | None |
| P30CA016672 | NIH | M D Anderson Cancer Center | httpsreporternihgovquickSearchP30CA016672 |