Clinical trial · Observational
Ductal Lavage in Assessing Women With Early Breast Cancer or at High Risk of Developing Breast Cancer and Who Are Eligible For Tamoxifen Therapy
Surrogate Endpoints in Prevention Studies and Ductal Lavage
NCT00083044CI-TRIAL-00006781withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding ended and will not be renewed
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Cell morphology and protein expression of breast epithelial cells in duct lavage samples as a marker of tamoxifen effect
- timeFrame
- Before and after tamoxifen treatment
- measure
- Methylation status of genes previously identified to be related to neoplastic progression of cells in ductal lavage samples
- timeFrame
- At time of each ductal lavage.
- measure
- Protein profile of nipple aspiration fluid before and after tamoxifen treatment
- timeFrame
- Before and after tamoxifen treatment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Diagnosis of small invasive breast cancer * Diagnosis of ductal or lobular carcinoma in situ of the breast * At high risk for breast cancer (5-year Gail model risk of \> 1.6%) * 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: * Estrogen receptor-positive (in patients with small invasive breast cancer) PATIENT CHARACTERISTICS: Age * 18 to 64 Sex * Female Menopausal Status * Premenopausal or postmenopausal Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * No prior venous thromboembolism Other * At least 12 months post-partum * Not pregnant * Not nursing within the past 12 months * No known allergy to lidocaine, prilocaine, or bupivacaine * No uterine hyperplasia or polyps * No other contraindication to tamoxifen PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * More than 6 months since prior chemotherapy Endocrine therapy * Concurrent hormone-replacement therapy allowed * Prior tamoxifen or raloxifene allowed provided treatment duration was no more than 6 months * At least 1 year since prior raloxifene Radiotherapy * Not specified Surgery * Not specified
References
Publications (9)
- BACKGROUNDBhandare 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. PMID 16458282
- BACKGROUNDGorla 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.
- BACKGROUNDLi 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. PMID 16322290
- BACKGROUNDGolewale 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.
- RESULTPatil 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. PMID 18097749
- RESULTFackler 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.
- RESULTBhandare 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.
- RESULTBhandare 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.