NCT00083044

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2003

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2004

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

April 25, 2012

Status Verified

April 1, 2012

Enrollment Period

4.8 years

First QC Date

May 14, 2004

Last Update Submit

April 24, 2012

Conditions

Breast Cancer

Keywords

breast cancerbreast cancer in situstage I breast cancerlobular breast carcinoma in situductal breast carcinoma in situ

Outcome Measures

Primary Outcomes (3)

  • 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.

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women with early breast cancer or at high risk of developing breast cancer and who are eligible for tamoxifen therapy

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Related Publications (9)

  • 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.

    PMID: 16458282BACKGROUND

  • 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.

    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.

    PMID: 16322290BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 18097749RESULT

  • 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.

    RESULT

MeSH Terms

Conditions

Breast NeoplasmsBreast Carcinoma In SituCarcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeAdenocarcinomaNeoplasms, Ductal, Lobular, and Medullary

Study Officials

  • Seema A. Khan, MD

    Robert H. Lurie Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2004

First Posted

May 17, 2004

Study Start

October 1, 2003

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

April 25, 2012

Record last verified: 2012-04

Locations

US(2)