Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126464
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2005-08-02
Brief Title:
Fulvestrant or Tamoxifen in Treating Postmenopausal Women Who Are Undergoing Surgery for Ductal Carcinoma in Situ of the Breast
Sponsor:
Cedars-Sinai Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant Faslodex in Breast Ductal Carcinoma DCIS
Status:
UNKNOWN
Status Verified Date:
2006-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 can cause the growth of breast cancer cells Hormone therapy using fulvestrant or tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells Giving fulvestrant or tamoxifen before surgery may be an effective treatment for breast cancer
PURPOSE This randomized clinical trial is studying how well giving fulvestrant or tamoxifen works in treating postmenopausal women who are undergoing surgery for ductal carcinoma in situ of the breast
PURPOSE This randomized clinical trial is studying how well giving fulvestrant or tamoxifen works in treating postmenopausal women who are undergoing surgery for ductal carcinoma in situ of the breast
Detailed Description:
OBJECTIVES
Primary
Determine preliminarily the efficacy of neoadjuvant fulvestrant in terms of molecular changes in markers of the estrogen pathway cell proliferation and apoptosis and the epidermal growth factor pathway in postmenopausal women with newly diagnosed ductal carcinoma in situ of the breast
Secondary
Determine the toxicity profile of fulvestrant in these patients
OUTLINE This is a randomized placebo-controlled pilot multicenter study Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive oral placebo once daily on days 1-21
Arm II Patients receive oral tamoxifen once daily on days 1-21
Arm III Patients receive fulvestrant intramuscularly IM on day 1
Arm IV Patients receive fulvestrant IM as in arm III but at a higher dose In all arms treatment continues in the absence of disease progression or unacceptable toxicity All patients undergo surgical resection of the tumor on approximately day 21
PROJECTED ACCRUAL A total of 100 patients 25 per treatment arm will be accrued for this study
Primary
Determine preliminarily the efficacy of neoadjuvant fulvestrant in terms of molecular changes in markers of the estrogen pathway cell proliferation and apoptosis and the epidermal growth factor pathway in postmenopausal women with newly diagnosed ductal carcinoma in situ of the breast
Secondary
Determine the toxicity profile of fulvestrant in these patients
OUTLINE This is a randomized placebo-controlled pilot multicenter study Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive oral placebo once daily on days 1-21
Arm II Patients receive oral tamoxifen once daily on days 1-21
Arm III Patients receive fulvestrant intramuscularly IM on day 1
Arm IV Patients receive fulvestrant IM as in arm III but at a higher dose In all arms treatment continues in the absence of disease progression or unacceptable toxicity All patients undergo surgical resection of the tumor on approximately day 21
PROJECTED ACCRUAL A total of 100 patients 25 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| CSMC-1B-03-7 | None | None | None |
| CSMC-00000244 | None | None | None |
| CSMC-4415CR00000244 | None | None | None |
| ZENECA-CSMC-00000244 | None | None | None |