Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00253539
Status:
COMPLETED
Last Update Posted:
2011-04-13
First Post:
2005-11-11
Brief Title:
Arzoxifene or Tamoxifen in Preventing Breast Cancer in Premenopausal Women at High Risk for Breast Cancer
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
A Phase II Study of a Selective Estrogen Receptor Modulator LY353381 vs Tamoxifen vs Placebo in Premenopausal Women With and Increased Risk for Breast Cancer
Status:
COMPLETED
Status Verified Date:
2011-04
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 Chemoprevention is the use of certain drugs to keep cancer from forming growing or coming back Estrogen can cause the growth of breast cancer cells Hormone therapy using arzoxifene or tamoxifen may prevent breast cancer by lowering the amount of estrogen the body makes The use of arzoxifene or tamoxifen may keep breast cancer from forming in women at high risk for breast cancer
PURPOSE This randomized phase II trial is studying arzoxifene to see how well it works compared to tamoxifen or a placebo in preventing breast cancer in premenopausal women at high risk for breast cancer
PURPOSE This randomized phase II trial is studying arzoxifene to see how well it works compared to tamoxifen or a placebo in preventing breast cancer in premenopausal women at high risk for breast cancer
Detailed Description:
OBJECTIVES
Compare the effect of arzoxifene vs tamoxifen vs placebo on surrogate endpoints biomarkers especially systemic insulin-like growth factor levels in women at high risk for breast cancer
Compare the toxic effects biologic effects clinical pharmacology and pharmacodynamics of these drugs in these participants
Determine the effect of these drugs on surrogate endpoint biomarkers in participants with BRCA1 and BRCA2 mutations
Determine the feasibility of a chemoprevention study in participants with a strong family history of breast cancer
OUTLINE This is a randomized placebo-controlled double-blind study Participants are randomized to 1 of 3 treatment arms
Arm I Participants receive oral tamoxifen once daily
Arm II Participants receive oral arzoxifene once daily
Arm III Participants receive an oral placebo once daily In all arms treatment continues for 6 months in the absence of disease progression or unacceptable toxicity After the completion of 6 months of treatment participants are offered the opportunity to continue treatment with their assigned study drug for an additional 6 months Participants randomized to receive placebo are offered treatment with arzoxifene for an additional 6 months
After completion of study treatment participants are followed annually
PROJECTED ACCRUAL A total of 120 participants will be accrued for this study
Compare the effect of arzoxifene vs tamoxifen vs placebo on surrogate endpoints biomarkers especially systemic insulin-like growth factor levels in women at high risk for breast cancer
Compare the toxic effects biologic effects clinical pharmacology and pharmacodynamics of these drugs in these participants
Determine the effect of these drugs on surrogate endpoint biomarkers in participants with BRCA1 and BRCA2 mutations
Determine the feasibility of a chemoprevention study in participants with a strong family history of breast cancer
OUTLINE This is a randomized placebo-controlled double-blind study Participants are randomized to 1 of 3 treatment arms
Arm I Participants receive oral tamoxifen once daily
Arm II Participants receive oral arzoxifene once daily
Arm III Participants receive an oral placebo once daily In all arms treatment continues for 6 months in the absence of disease progression or unacceptable toxicity After the completion of 6 months of treatment participants are offered the opportunity to continue treatment with their assigned study drug for an additional 6 months Participants randomized to receive placebo are offered treatment with arzoxifene for an additional 6 months
After completion of study treatment participants are followed annually
PROJECTED ACCRUAL A total of 120 participants will be accrued for this study
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 |
|---|---|---|---|
| P30CA043703 | NIH | None | httpsreporternihgovquickSearchP30CA043703 |