Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT00290758
Status:
COMPLETED
Last Update Posted:
2017-02-08
First Post:
2006-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Genistein in Preventing Breast Cancer in Women at High Risk for Breast Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
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:
True
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?: