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1) Effects of Therapeutic Agents on Estrogens in the Breast 2) Utilizing the Resources of the Breast Cancer Collaborative Registry (BCCR)


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

Thank you

Trial Information

1) Effects of Therapeutic Agents on Estrogens in the Breast 2) Utilizing the Resources of the Breast Cancer Collaborative Registry (BCCR)


OBJECTIVES:

- To learn the effects of selected agents (tamoxifen and aromatase inhibitors) on the
profile of estrogen metabolites, glutathione conjugates, and depurinating DNA adducts
in urine from women with breast cancer.

OUTLINE: Previously collected urine samples are analyzed for 40 estrogen metabolites,
conjugates, and depurinating DNA adducts by ultra-performance liquid chromatography with
tandem mass spectrometric detection.

Patient information (e.g., race, body mass index, age at menarche, menopausal status, age at
menopause if applicable, smoking history, alcohol consumption) is collected through medical
record review.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Newly diagnosed ductal carcinoma in situ or invasive breast cancer

- Urine biospecimens available from participation in protocol UNMC-08105 (IRB#311-06),
the Breast Cancer Collaborative Registry (BCCR), which included treatment with
tamoxifen or an aromatase inhibitor

- Urine specimens were collected at baseline, 6 months, and then annually

- Estrogen receptor or progesterone receptor positive

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- ECOG performance status 0-2

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No concurrent use of estrogen(s)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Estrogen compounds in urine

Outcome Time Frame:

at baseline at 6 months and annually

Safety Issue:

No

Principal Investigator

Ercole Cavalieri, DSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska

Authority:

United States: Federal Government

Study ID:

502-08

NCT ID:

NCT00959244

Start Date:

February 2009

Completion Date:

September 2009

Related Keywords:

  • Breast Cancer
  • 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

UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680