Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080613
Status:
WITHDRAWN
Last Update Posted:
2013-07-10
First Post:
2004-04-07
Brief Title:
Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
Sponsor:
Robert H Lurie Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Neoadjuvant and Adjuvant Exemestane in Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2006-12
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:
RATIONALE Estrogen and progesterone can stimulate the growth of breast cancer cells Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen and progesterone Giving hormone therapy before surgery may shrink the tumor so it can be removed with breast-conserving surgery Giving hormone therapy after surgery may kill any remaining tumor cells
PURPOSE Phase II trial to study the effectiveness of neoadjuvant and adjuvant exemestane in treating postmenopausal women who have locally advancedestrogen andor progesterone receptor-positive breast cancer
PURPOSE Phase II trial to study the effectiveness of neoadjuvant and adjuvant exemestane in treating postmenopausal women who have locally advancedestrogen andor progesterone receptor-positive breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the clinical response rate in postmenopausal women with locally advanced hormone receptor-positive breast cancer treated with neoadjuvant and adjuvant exemestane
Secondary
Determine the response rate by mammography ultrasound MRI and positron emission tomography scan in patients treated with this drug
Determine the time to progression in patients treated with this drug
Compare the expression of hormone receptors and epidermal growth factor receptors including HER2neu in patients prior to and after treatment with this drug and correlate these results with clinical response rates
OUTLINE Patients receive oral exemestane once daily for 16 weeks in the absence of disease progression or unacceptable toxicity After 16 weeks patients undergo surgery and then continue exemestane once daily for a total of 5 years including the 16 weeks before surgery
Patients are followed every 3 months for 2 years after surgery and then every 6 months thereafter
PROJECTED ACCRUAL A total of 16-46 patients will be accrued for this study within 2 years
Primary
Determine the clinical response rate in postmenopausal women with locally advanced hormone receptor-positive breast cancer treated with neoadjuvant and adjuvant exemestane
Secondary
Determine the response rate by mammography ultrasound MRI and positron emission tomography scan in patients treated with this drug
Determine the time to progression in patients treated with this drug
Compare the expression of hormone receptors and epidermal growth factor receptors including HER2neu in patients prior to and after treatment with this drug and correlate these results with clinical response rates
OUTLINE Patients receive oral exemestane once daily for 16 weeks in the absence of disease progression or unacceptable toxicity After 16 weeks patients undergo surgery and then continue exemestane once daily for a total of 5 years including the 16 weeks before surgery
Patients are followed every 3 months for 2 years after surgery and then every 6 months thereafter
PROJECTED ACCRUAL A total of 16-46 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000346457 | REGISTRY | PDQ Physician Data Query | None |