Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086749
Status:
COMPLETED
Last Update Posted:
2012-07-11
First Post:
2004-07-08
Brief Title:
Effect of Tamoxifen on Breast Density in Premenopausal Women With Breast Cancer or High Risk for Breast Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Prospective Study Of The Effect Of Tamoxifen On Breast Density In Premenopausal Women
Status:
COMPLETED
Status Verified Date:
2012-07
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 High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer Tamoxifen may be effective in reducing breast density by decreasing estrogen levels
PURPOSE This phase I trial is studying how well tamoxifen works in reducing breast density in premenopausal women with breast cancer or at high risk of developing breast cancer
PURPOSE This phase I trial is studying how well tamoxifen works in reducing breast density in premenopausal women with breast cancer or at high risk of developing breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine whether breast density as measured by digital mammography decreases in premenopausal women receiving tamoxifen for breast cancer or for breast cancer risk reduction
Determine whether breast density as determined by a trained mammographer decreases in patients treated with this drug
Correlate tamoxifen-induced symptoms in estrogen target tissue with change in salivary steroids in patients treated with this drug
Secondary
Determine the effect of this drug on salivary steroids in regularly cycling and amenorrheic patients
Correlate changes in breast density with tamoxifen-induced alterations in sex steroid levels as measured in the saliva of patients treated with this drug
OUTLINE Patients receive oral tamoxifen once daily Treatment continues for 5 years in the absence of disease metastasis patients with known breast cancer or a diagnosis of breast cancer patients undergoing risk reduction
Patients undergo mammography to determine breast density at baseline at 6 and 12 months and then annually for 4 years Patients also collect daily salivary samples during the 30-day periods surrounding the imaging studies to measure salivary estradiol and progesterone levels The results of the salivary hormone studies are correlated with density changes at study completion
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study
Primary
Determine whether breast density as measured by digital mammography decreases in premenopausal women receiving tamoxifen for breast cancer or for breast cancer risk reduction
Determine whether breast density as determined by a trained mammographer decreases in patients treated with this drug
Correlate tamoxifen-induced symptoms in estrogen target tissue with change in salivary steroids in patients treated with this drug
Secondary
Determine the effect of this drug on salivary steroids in regularly cycling and amenorrheic patients
Correlate changes in breast density with tamoxifen-induced alterations in sex steroid levels as measured in the saliva of patients treated with this drug
OUTLINE Patients receive oral tamoxifen once daily Treatment continues for 5 years in the absence of disease metastasis patients with known breast cancer or a diagnosis of breast cancer patients undergoing risk reduction
Patients undergo mammography to determine breast density at baseline at 6 and 12 months and then annually for 4 years Patients also collect daily salivary samples during the 30-day periods surrounding the imaging studies to measure salivary estradiol and progesterone levels The results of the salivary hormone studies are correlated with density changes at study completion
PROJECTED ACCRUAL A total of 100 patients 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 |
|---|---|---|---|
| NCI-00B2 | None | None | None |
| NU-NCI-00B2 | None | None | None |