Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217399
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2005-09-20
Brief Title:
Sorafenib and Anastrozole in Treating Postmenopausal Women With Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial of BAY 43-9006 Sorafenib in Combination With Anastrozole in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-12
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:
Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth Estradiol can cause the growth of breast cancer Hormone therapy using anastrozole may fight breast cancer by blocking the use of estradiol by the tumor cells Sometimes when hormone therapy is given it does not stop the growth of tumor cells The tumor is said to be resistant to hormone therapy Giving sorafenib together with anastrozole may reduce drug resistance and allow the tumor cells to be killed This phase III trial is studying the side effects and best dose of sorafenib when given in combination with anastrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the clinical benefit rate of sorafenib in combination with anastrazole in women with estrogen receptor- andor progesterone receptor-positive metastatic breast cancer
II Determine the recommended phase II dose of sorafenib when administered with anastrozole in these patients
SECONDARY OBJECTIVES
I Determine the toxic effects of this regimen in these patients II Determine the changes in Raf-MAPK and VEGF-signaling pathways in tumor tissue and stroma before and after treatment with this regimen in these patients
OUTLINE This is a multicenter dose-escalation study of sorafenib
PHASE I Patients receive oral sorafenib twice daily and oral anastrozole once daily on days 1-28
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity A minimum of 6 patients are treated at the MTD
PHASE II Patients receive sorafenib at the MTD and anastrozole as in phase I
After completion of study treatment patients are followed every 4-8 weeks
I Determine the clinical benefit rate of sorafenib in combination with anastrazole in women with estrogen receptor- andor progesterone receptor-positive metastatic breast cancer
II Determine the recommended phase II dose of sorafenib when administered with anastrozole in these patients
SECONDARY OBJECTIVES
I Determine the toxic effects of this regimen in these patients II Determine the changes in Raf-MAPK and VEGF-signaling pathways in tumor tissue and stroma before and after treatment with this regimen in these patients
OUTLINE This is a multicenter dose-escalation study of sorafenib
PHASE I Patients receive oral sorafenib twice daily and oral anastrozole once daily on days 1-28
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity A minimum of 6 patients are treated at the MTD
PHASE II Patients receive sorafenib at the MTD and anastrozole as in phase I
After completion of study treatment patients are followed every 4-8 weeks
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 |
|---|---|---|---|
| 6584 | OTHER | CTEP | None |
| NCI-2009-00069 | REGISTRY | None | None |
| CDR0000440067 | None | None | None |
| 2004-251 | None | None | None |
| 2004-251 | OTHER | None | None |