Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00290758
Status:
COMPLETED
Last Update Posted:
2017-02-08
First Post:
2006-02-09
Brief Title:
Genistein in Preventing Breast Cancer in Women at High Risk for Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase IIB Trial of G-2535 Unconjugated Isoflavones-100 in Women at High Risk for Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
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:
This randomized phase II trial is studying how well genistein works in preventing breast cancer in women at high risk for breast cancer Chemoprevention is the use of certain drugs to keep cancer from forming growing or coming back The use of genistein may prevent breast cancer in women at high risk for breast cancer
Detailed Description:
PRIMARY OBJECTIVE
I Determine the effect of genistein on the proliferation of breast epithelial cells obtained by fine needle aspiration FNA as measured by Ki-67 labeling index in women who are at high risk for breast cancer
SECONDARY OBJECTIVE
I Determine the effect of this drug on cellular and molecular parameters using epithelial cells obtained by FNA nipple aspirate fluid and blood from these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to menopausal status premenopausal vs postmenopausal and history of breast cancer no history of breast cancer vs history of estrogen receptor ER positive breast cancer vs history of ER negative breast cancer Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive oral genistein once daily
ARM II Patients receive oral placebo once daily
In both arms treatment continues for up to 6 months in the absence of unacceptable toxicity
After completion of study treatment patients are followed at 30-37 days
I Determine the effect of genistein on the proliferation of breast epithelial cells obtained by fine needle aspiration FNA as measured by Ki-67 labeling index in women who are at high risk for breast cancer
SECONDARY OBJECTIVE
I Determine the effect of this drug on cellular and molecular parameters using epithelial cells obtained by FNA nipple aspirate fluid and blood from these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to menopausal status premenopausal vs postmenopausal and history of breast cancer no history of breast cancer vs history of estrogen receptor ER positive breast cancer vs history of ER negative breast cancer Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive oral genistein once daily
ARM II Patients receive oral placebo once daily
In both arms treatment continues for up to 6 months in the absence of unacceptable toxicity
After completion of study treatment patients are followed at 30-37 days
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 |
|---|---|---|---|
| NCI-2009-00840 | REGISTRY | None | None |
| CDR0000652922 | None | None | None |
| NCI-04B3 | OTHER | None | None |
| NWU03-1-04 | OTHER | None | None |
| N01CN35157 | NIH | DCP | httpsreporternihgovquickSearchN01CN35157 |