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| Sponsors and Collaborators: |
University of Nebraska National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00569543 |
Purpose
RATIONALE: Studying samples of urine in the laboratory from women with breast cancer may help doctors learn whether tamoxifen and aromatase inhibitors alter the metabolism of estrogens.
PURPOSE: This clinical trial is studying the effect of tamoxifen or an aromatase inhibitor on estrogen metabolism in women undergoing treatment for newly diagnosed breast cancer.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Drug: aromatase inhibition therapy Drug: tamoxifen citrate Other: high performance liquid chromatography Other: laboratory biomarker analysis Other: mass spectrometry Other: medical chart review |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Effects of Therapeutic Agents on Estrogens in the Breast |
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2005 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients are stratified according to planned therapy (tamoxifen citrate vs aromatase inhibitor).
Patients receive tamoxifen citrate or an aromatase inhibitor as planned. Urine samples (and nipple aspirate fluid, if possible) are collected before beginning treatment and after 2-6 months of treatment. Samples are analyzed for 40 estrogen metabolites, conjugates, and depurinating DNA adducts by ultraperformance liquid chromatography with tandem mass spectrometric detection.
Patients' information, including race, body mass index, age at menarche, menopausal status, age at menopause if applicable, smoking history, alcohol consumption, pregnancy history including age at each pregnancy, lactation, history of benign breast disease, hysterectomy, and disease type, is collected through medical record review.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Nebraska | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-6805 | |
| Principal Investigator: | Ercole Cavalieri, DSc | University of Nebraska |
More Information
| Study ID Numbers: | CDR0000579225, UNMC-08105 |
| Study First Received: | December 6, 2007 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00569543 History of Changes |
| Health Authority: | United States: Federal Government |
|
breast cancer in situ ductal breast carcinoma in situ stage I breast cancer stage II breast cancer |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
|
Estrogen Antagonists Estrogens Skin Diseases Antineoplastic Agents, Hormonal Hormone Antagonists Citric Acid Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Bone Density Conservation Agents Selective Estrogen Receptor Modulators |
Hormones Tamoxifen Carcinoma Estrogen Receptor Modulators Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Aromatase Inhibitors Breast Diseases |
|
Estrogen Antagonists Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Enzyme Inhibitors |
Bone Density Conservation Agents Selective Estrogen Receptor Modulators Tamoxifen Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Aromatase Inhibitors Breast Diseases |
