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| ID | Type | Description | Link |
|---|---|---|---|
| NU-0649-003 |
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Funding ended and will not be renewed
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Cell morphology and protein expression of breast epithelial cells in duct lavage samples as a marker of tamoxifen effect | Before and after tamoxifen treatment | |
| Methylation status of genes previously identified to be related to neoplastic progression of cells in ductal lavage samples | At time of each ductal lavage. | |
| Protein profile of nipple aspiration fluid before and after tamoxifen treatment | Before and after tamoxifen treatment. |
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DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Eligible for tamoxifen therapy
No plans for adjuvant chemotherapy
Prior unilateral early breast cancer allowed* NOTE: *Only the unaffected breast will be examined during this study
Hormone-receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal Status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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Women with early breast cancer or at high risk of developing breast cancer and who are eligible for tamoxifen therapy
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| Name | Affiliation | Role |
|---|---|---|
| Seema A. Khan, MD | Robert H. Lurie Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16458282 | Background | Bhandare DJ, Khan SA, Motchoulskaia NA, Melnikov AA, Levenson Chernokhvostov VV. Isolation of highly purified DNA from low-abundance archived and stained cytological specimens. Clin Chim Acta. 2006 May;367(1-2):211-3. doi: 10.1016/j.cca.2005.12.022. Epub 2006 Feb 2. No abstract available. | |
| Background | Gorla SR, Steel J, Cohn R, et al.: Impact of surgical resection of primary breast tumor in stage IV breast cancer on local control and survival. [Abstract] J Clin Oncol 23 (Suppl 16): A-629, 35s, 2005. | ||
| 16322290 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Robert H. Lurie Comprehensive Cancer Center at Northwestern University |
| Chicago |
| Illinois |
| 60611-3013 |
| United States |
| Background |
| Li J, Zhao J, Yu X, Lange J, Kuerer H, Krishnamurthy S, Schilling E, Khan SA, Sukumar S, Chan DW. Identification of biomarkers for breast cancer in nipple aspiration and ductal lavage fluid. Clin Cancer Res. 2005 Dec 1;11(23):8312-20. doi: 10.1158/1078-0432.CCR-05-1538. |
| Background | Golewale NH, Bryk M, Nayar R, et al.: Technical modifications of ductal lavage to improve cell yield. [Abstract] Breast Cancer Research and Treatment 82 (Suppl 1): A-1024, 2003. |
| 18097749 | Result | Patil DB, Lankes HA, Nayar R, Masood S, Bryk M, Hou N, Rademaker A, Khan SA. Reproducibility of ductal lavage cytology and cellularity over a six month interval in high risk women. Breast Cancer Res Treat. 2008 Nov;112(2):327-33. doi: 10.1007/s10549-007-9861-8. Epub 2007 Dec 21. |
| Result | Fackler MJ, Malone K, Schilling E, et al.: Methylated genes in ductal lavage fluid from women with known breast cancer undergoing mastectomy. [Abstract] Breast Cancer Res Treat 94 (Suppl 1): A-2007, S85, 2005. |
| Result | Bhandare D, Bryk M, Nayar R, et al.: Effect of Tamoxifen (TAM) on estrogen-related biomarkers in ductal lavage (DL) samples a study on follow-up lavages. [Abstract] Breast Cancer Research and Treatment 88 (Suppl 1): A-4031, 2004. |
| Result | Bhandare D, Golewale N, Geiger A, et al.: Estrogen related biomarkers and cellular atypia in ductal lavage (DL) samples from women at high risk for breast cancer. [Abstract] Breast Cancer Res Treat 82 (Suppl 1): A-1032, S178, 2003. |
| Result | Didwania A, Golewale NH, Khan SA, et al.: Influence of ductal lavage (DL) findings on tamoxifen decision for high risk women. [Abstract] Breast Cancer Res Treat 82 (Suppl 1): A-1037, S179, 2003. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |