Status:
COMPLETED
Studying Biomarkers in Nipple Fluid, Urine, and Blood Samples From Women With Newly Diagnosed Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer and in Women at Risk of Developing Breast Cancer
Lead Sponsor:
Mayo Clinic
Conditions:
Breast Cancer
Eligibility:
FEMALE
19-80 years
Brief Summary
RATIONALE: Studying samples of nipple fluid, urine, and blood in the laboratory from patients with cancer and from patients at risk of developing cancer may help doctors identify and learn more about ...
Detailed Description
OBJECTIVES: * To determine the levels of catechol estrogens (CE), CE metabolites, CE-DNA adducts, and CE conjugates in nipple aspirate fluid samples obtained from women with newly diagnosed ductal ca...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Newly diagnosed (within 30 calendar days of diagnosis) stage I or II breast cancer
- Node-negative or node-positive disease
- Newly diagnosed ductal carcinoma in situ (stage 0) of the breast
- At high risk of developing breast cancer, as indicated by at least 1 of the following criteria:
- Gail model 5-year risk score ≥ 1.66%
- Gail model lifetime-risk estimate ≥ 20%
- Known deleterious BRCA 1 or 2 gene mutation carrier
- History of lobular carcinoma in situ or atypical ductal or lobular hyperplasia
- At low or average risk of developing breast cancer (control group)
- Gail model 5-year risk score \< 1.66% or lifetime risk \< 20%
- No advanced breast cancer
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Pre- or post-menopausal
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for breast cancer or any other cancer
- More than 3 months since prior and no concurrent estrogen or other hormones
- More than 3 months since prior oral contraceptives
- No concurrent selective estrogen receptor modulators (tamoxifen citrate or raloxifene)
- No concurrent aromatase inhibitors
Exclusion
Key Trial Info
Start Date :
May 20 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2015
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT00897208
Start Date
May 20 2005
End Date
June 30 2015
Last Update
October 5 2018
Active Locations (1)
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1
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905