Ductal Lavage in Assessing Women With Early Breast Cancer or at High Risk of Developing Breast Ca… (NCT00083044) | Clinical Trial Compass
WithdrawnNot Applicable
Ductal Lavage in Assessing Women With Early Breast Cancer or at High Risk of Developing Breast Cancer and Who Are Eligible For Tamoxifen Therapy
Stopped: Funding ended and will not be renewed
United States0Started 2003-10
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 spec…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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.
3
Protein profile of nipple aspiration fluid before and after tamoxifen treatment