Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131924
Status:
TERMINATED
Last Update Posted:
2012-06-11
First Post:
2005-08-16
Brief Title:
High-Dose Esterified Estrogens in Treating Postmenopausal Women With Metastatic Breast Cancer That Has Failed Previous Hormone Therapy
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase II Study of High-Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Data Monitoring Committee recommended closure due to poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE High doses of esterified estrogens may stop the growth of breast cancer cells that no longer respond to hormone therapy
PURPOSE This phase II trial is studying how well high-dose esterified estrogens work in treating postmenopausal women with metastatic breast cancer that has failed previous hormone therapy
PURPOSE This phase II trial is studying how well high-dose esterified estrogens work in treating postmenopausal women with metastatic breast cancer that has failed previous hormone therapy
Detailed Description:
OBJECTIVES
Primary
Determine the clinical response rate in postmenopausal women with estrogen andor progesterone receptor-positive metastatic breast cancer that has failed prior sequential endocrine therapy treated with high-dose esterified estrogens Menest
Secondary
Determine time to disease progression in patients treated with this drug
Determine the toxic effects of this drug in these patients
OUTLINE Patients receive oral high-dose esterified estrogens Menest 3 times daily Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for 2 months
PROJECTED ACCRUAL A total of 18-35 patients will be accrued for this study within 2 years
Primary
Determine the clinical response rate in postmenopausal women with estrogen andor progesterone receptor-positive metastatic breast cancer that has failed prior sequential endocrine therapy treated with high-dose esterified estrogens Menest
Secondary
Determine time to disease progression in patients treated with this drug
Determine the toxic effects of this drug in these patients
OUTLINE Patients receive oral high-dose esterified estrogens Menest 3 times daily Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for 2 months
PROJECTED ACCRUAL A total of 18-35 patients will be accrued for this study within 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 |
|---|---|---|---|
| NU-03B5 | None | None | None |