AzTrials
AzTrials

Breast CancerNCT00083044

Ductal Lavage in Assessing Women With Early Breast Cancer or at High Risk of Developing Breast Cancer and Who Are Eligible For Tamoxifen Therapy

An observational study of Breast Cancer, run by Northwestern University at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 64 years, women only
Conditions the study is for
Breast Cancer
How many people
0 participants
Where
2 sitesUnited States
Study dates
Oct 2003to Jul 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • Women only
  • No healthy volunteers
  • Adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Comprehensive Cancer Center at University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

Other trials in United States

About this study

Official title: Surrogate Endpoints in Prevention Studies and Ductal Lavage

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.

Read the 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.

Conditions
Breast Cancer
Keywords
breast cancer, breast cancer in situ, stage I breast cancer, lobular breast carcinoma in situ, ductal breast carcinoma in situ
Medical subject headings
Breast Neoplasms, Breast Carcinoma In Situ, Carcinoma, Intraductal, Noninfiltrating

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cell morphology and protein expression of breast epithelial cells in duct lavage samples as a marker of tamoxifen effect

    Measured: Before and after tamoxifen treatment

  2. Methylation status of genes previously identified to be related to neoplastic progression of cells in ductal lavage samples

    Measured: At time of each ductal lavage.

  3. Protein profile of nipple aspiration fluid before and after tamoxifen treatment

    Measured: Before and after tamoxifen treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2004 (estimated)
  2. Study startOct 2003
  3. Primary completionJul 2008
  4. Study completionJul 2008

Why it stopped: Funding ended and will not be renewed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00083044
Sponsor's protocol ID
GRANT P50CA89018
Other IDs
NU-0649-003
Status last verified
Apr 2012
First submitted
14 May 2004
Last updated
25 Apr 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16458282

  • 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.

  • 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.

    PubMed 16322290

  • 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.

  • 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.

    PubMed 18097749

  • 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.

  • 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.

  • 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.

  • 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Northwestern University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cell morphology and protein expression of breast epithelial cells in duct lavage samples as a marker of tamoxifen effect (time frame: Before and after tamoxifen treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00083044, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in