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The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: A Companion Study to NCIC CTG MA.27

18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: A Companion Study to NCIC CTG MA.27



- Assess the change in percent breast density and dense area in response to aromatase
inhibitor therapy from pretreatment to 1 year, 1 year to 2 years, and pretreatment to 2
years in women with invasive breast cancer.

- Determine the changes in percent breast density and dense area in response to aromatase
inhibitor therapy from pretreatment to 1 year and correlate the changes with changes in
plasma hormones (e.g., estrone, estrone-sulfate, estradiol, and sex hormone binding
globulin) and drug levels (anastrozole or exemestane) over the same period in women
with invasive breast cancer.

- Determine the change over time in percent breast density and dense area (from
pretreatment to the time period prior to local recurrence) in the contralateral breast
in correlation to local recurrence of breast cancer.


- Determine the change over time in percent breast density and dense area in the
contralateral breast in correlation to the development of contralateral breast cancer.

- Determine whether women with high pretreatment percent density (upper tertile)
experience greater decreases in percent breast density at 1 and 2 years of aromatase
inhibitor therapy than women with low pretreatment percent density (lower tertile).

- Determine whether women with high pretreatment dense area (upper tertile) experience
greater decreases in dense area at 1 and 2 years of aromatase inhibitor therapy than
women with low pretreatment dense area (lower tertile).

- Correlate haplotype tagged single nucleotide polymorphisms in genes in the aromatase
pathway (identified thorough the Mayo Clinic and Indiana University Pharmacogenomics
Research Network Projects) with changes in percent and area breast density, plasma
hormone levels, and 1-year drug levels.

OUTLINE: This is a multicenter, companion study.

Patients complete a 10-minute questionnaire about factors that might affect changes in
breast density at baseline and another questionnaire at 1 year and 2 years post
registration. Blood samples are collected at baseline (before initiation of treatment ) and
at 1 year post registration for hormone and drug level analysis. Mammograms taken prior to
registration (within 12 months prior to enrollment) and at approximately 1 and 2 years
post-registration to this study are retrieved and digitized for determination of percent
breast density and dense area.

PROJECTED ACCRUAL: A total of 550 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed invasive breast cancer

- Completely resected disease

- One intact, noncancerous breast with no prior breast surgery in that breast except
breast biopsy

- Mammogram available taken within 12 months prior to enrollment that includes
side- and top-down views of the intact, noncancerous breast

- Estrogen receptor- and/or progesterone receptor-positive tumor


- Female

- Postmenopausal

- Agrees to retrieve and digitize mammograms taken prior to registration (within 12
months prior to atudy entry) and at approximately 1 and 2 years post-registration to
this study

- Agrees to have an additional blood banking specimen drawn at the same time as
pre-treatment specimens are drawn for parent protocol CAN-NCIC-MA27

- Agrees to have blood sample taken at 12 months post-registration on this study


- See Disease Characteristics

- More than 6 months since prior hormone replacement therapy, oral contraceptives,
tamoxifen, raloxifene, other selective estrogen-receptor modulators, or gonadotropin
releasing-hormone analogues before pre-registration mammogram

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Changes in breast density measured by percent and area at 1 and 2 years

Safety Issue:


Principal Investigator

James N. Ingle, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

April 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms



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