Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083044
Status:
WITHDRAWN
Last Update Posted:
2012-04-25
First Post:
2004-05-14
Brief Title:
Ductal Lavage in Assessing Women With Early Breast Cancer or at High Risk of Developing Breast Cancer and Who Are Eligible For Tamoxifen Therapy
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Surrogate Endpoints in Prevention Studies and Ductal Lavage
Status:
WITHDRAWN
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding ended and will not be renewed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer Diagnostic procedures such as ductal lavage may improve the ability to assess the effectiveness of chemopreventive drugs such as tamoxifen on breast cells and may help doctors plan more effective treatment
PURPOSE This phase II trial is studying how well ductal lavage works in assessing changes in breast cells in women with early breast cancer or in those at high risk of developing breast cancer who are eligible for tamoxifen therapy
PURPOSE This phase II trial is studying how well ductal lavage works in assessing changes in breast cells in women with early breast cancer or in those at high risk of developing breast cancer who are eligible for tamoxifen therapy
Detailed Description:
OBJECTIVES
Evaluate cell morphology and protein expression of breast epithelial cells in ductal lavage samples as a marker of tamoxifen effect from women with breast cancer or from women at high risk for developing breast cancer
Evaluate methylation status of genes previously identified to be related to neoplastic progression of cells in ductal lavage samples from these participants
Evaluate the protein profile of nipple aspiration fluid from these participants before and after treatment with tamoxifen
OUTLINE This is a multicenter study
Participants who are eligible for tamoxifen chemoprevention therapy undergo ductal lavage Participants are informed of cytological findings and choose to receive oral tamoxifen once daily for 5 years vs observation only All participants undergo repeat ductal lavage at 6 months Participants with atypical cytology undergo a third ductal lavage at 12 months
Mammographic density is measured at study entry and at 12 months
Ductal cells are analyzed for methylation status of candidate genes
Participants are followed as clinically indicated
PROJECTED ACCRUAL A total of 200 participants will be accrued for this study
Evaluate cell morphology and protein expression of breast epithelial cells in ductal lavage samples as a marker of tamoxifen effect from women with breast cancer or from women at high risk for developing breast cancer
Evaluate methylation status of genes previously identified to be related to neoplastic progression of cells in ductal lavage samples from these participants
Evaluate the protein profile of nipple aspiration fluid from these participants before and after treatment with tamoxifen
OUTLINE This is a multicenter study
Participants who are eligible for tamoxifen chemoprevention therapy undergo ductal lavage Participants are informed of cytological findings and choose to receive oral tamoxifen once daily for 5 years vs observation only All participants undergo repeat ductal lavage at 6 months Participants with atypical cytology undergo a third ductal lavage at 12 months
Mammographic density is measured at study entry and at 12 months
Ductal cells are analyzed for methylation status of candidate genes
Participants are followed as clinically indicated
PROJECTED ACCRUAL A total of 200 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 |
|---|---|---|---|
| NU-0649-003 | None | None | None |