Clinical trial NCT00897208: 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
Official title: Estrogen-DNA Adducts in Breast, Urine and Serum as Biomarkers of Breast Cancer Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
ductal breast carcinoma in situ
breast cancer in situ
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-05-12
Enrollment: 316
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population is adult women, ages 19 to 80 years of age. In 2003, there were approximately 2000 new and 3000 established patient visits in the Breast Diagnostic Clinic (BDC) and Breast Cancer Clinic (BCC) Our new patients include those seen in the BDC with new breast concerns and those at seeking counseling regarding a family history or at high risk for developing breast cancer, as well as those women seen in the BCC with a new diagnosis of invasive or non-invasive breast cancer.

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 biomarkers related to cancer. It may also help doctors learn more about breast cancer and identify patients at risk of developing breast cancer.

PURPOSE: This laboratory study is looking at 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.

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 carcinoma in situ or stage I or II breast cancer and from women at high risk of developing breast cancer.

OUTLINE: Patients with newly diagnosed breast cancer or at high risk of developing breast cancer undergo nipple aspiration. The nipple aspirate fluid is obtained from the unaffected breast and is analyzed for 31 estrogen metabolites, conjugates, and depurinating DNA adducts by high-performance liquid chromatography (LC) with electrochemical and mass spectrometric detectors. All patients undergo urine and serum sample collection. The urine samples are analyzed by ultraperformance LC monitored by tandem mass spectrometry for estrogen metabolites, conjugates, and depurinating DNA adducts.

Patients' charts are reviewed to obtain information about age, race, general health, any endocrine disorders, history of cancer, estrogen and progesterone receptor status, and HER2/neu status (for patients with newly diagnosed breast cancer), menopausal status, reproductive history, history of breast disease, medication use, smoking history, and history of alcohol consumption.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the levels of estrogens, catechol estrogen (CE) metabolites, CE-glutathione conjugates, and CE-DNA adducts (N3Ade and N7Gua) among healthy women, high-risk women, and women with breast cancer
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sandhya Pruthi, MD
role: PRINCIPAL_INVESTIGATOR
References: