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Effects of Therapeutic Agents on Estrogens in the Breast


N/A
19 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Effects of Therapeutic Agents on Estrogens in the Breast


OBJECTIVES:

- Learn the effects of selected chemotherapy agents on the profile of estrogen
metabolites, glutathione conjugates, and depurinating DNA adducts in urine from women
with breast cancer.

- Determine whether tamoxifen citrate or aromatase inhibitor alters the metabolism of
estrogens.

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Newly diagnosed ductal carcinoma in situ or invasive breast cancer

- Scheduled to receive tamoxifen citrate or an aromatase inhibitor

- Estrogen receptor or progesterone receptor positive

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- ECOG performance status 0, 1, or 2

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

- No prior antiestrogen drug such as tamoxifen citrate or raloxifene

- No concurrent estrogens

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Comparison of the estrogen compounds in urine

Outcome Time Frame:

before and after treatment with tamoxifen or an aromatase inhibitor for two-to-six months

Safety Issue:

No

Principal Investigator

Ercole Cavalieri, DSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska

Authority:

United States: Federal Government

Study ID:

081-05

NCT ID:

NCT00569543

Start Date:

May 2005

Completion Date:

August 2012

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms

Name

Location
Mayo Clinic Cancer Center Rochester, Minnesota  55905
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680