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Premenopausal Hormone Concentrations in a Population of Women at Very Low Risk of Breast Cancer

25 Years
44 Years
Not Enrolling
Breast Cancer

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Trial Information

Premenopausal Hormone Concentrations in a Population of Women at Very Low Risk of Breast Cancer

There are striking differences in breast cancer incidence rates between Asian and North
American and Western European populations, but within Asia variation is also wide. Incidence
in Mongolia is one of the lowest in the world (6.6/100,000) while China, its neighbor to the
south, has about three times this rate (18.7/100,000). Furthermore, rates appear higher in
urban than in rural areas in Mongolia. Over the last decade and a half Mongolia has
experienced profound economic changes resulting in mass migration from a nomadic or
semi-nomadic existence to a more western lifestyle in the capital city of Ulaanbaatar, and
some back migration to rural areas. Together with the contrast in exposures between
traditional and urban settings, migration presents the opportunity to study women as they
acculturate to a more western lifestyle.

We propose collecting blood and urine samples from premenopausal Mongolian women living in
UlaanBaatar, the capital of Mongolia, to describe concentrations of several steroid hormones
and growth factors that play a role in breast cancer development. The purpose of the study
is to assess whether endocrine profile differs by degree of Western acculturation among
those who have recently migrated to the capital. Subjects will be recruited among mothers of
girls participating in a study of milk consumption and hormonal status presently being
conducted by our colleagues at Harvard Medical School. In addition to the blood draw and
urine collection, participants will have their height and weight measured and will complete
a questionnaire on reproductive and medical history, migration status and lifestyle factors.
Premenopausal blood samples with accompanying information on medical history and lifestyle
factors from women participating in Project Viva in Boston, Massachusetts will provide a
comparison group of US women at high breast cancer risk.

In general, Asian countries have been treated as one entity and the substantial variation in
breast cancer incidence among the countries that make up this large geographic area has not
been addressed. This variation among Asian countries may provide further opportunity for
hypothesis generating as we seek to determine what factors explain differences in breast
cancer rates between populations. Studies of a range of biological parameters in
premenopausal women among different racial/ethnic populations with varying breast cancer
incidence would be informative.

Inclusion Criteria

- Participants will be drawn from a group of mothers whose children are participating
in a study that will be conducted by our colleagues at Harvard Medical School. The
Harvard study is a randomized trial among 750 3rd grade children (aged 9-11) to
determine the impact of various types of vitamin D fortified and unfortified milk and
vitamin D supplements on levels of 25(OHD), growth hormone, and IGF-1. Children in
this study will be recruited at eleven primary schools in Ulaanbaatar. The trial will
run from January through March 2009 and will include 375 girls; we estimate that
their mothers will be roughly 30-45 years of age, and few will be pregnant.

We plan to recruit participants for our study at the time of the baseline blood draw in
their daughters. Women ages 25-44 are eligible who are not pregnant or breastfeeding.

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Serum concentrations of angiogenic factors and urinary steroid hormone.

Principal Investigator

Robert N Hoover, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

February 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Mongolia
  • Asia
  • Breast Cancer
  • Hormones
  • Premenopausal
  • Breast Neoplasms



Brigham and Women's Hospital Boston, Massachusetts  02115
Dana Farber Cancer Institute Boston, Massachusetts  02115
Harvard Medical School Boston, Massachusetts  02115