Screening study for cancer biomarkers in breast milk.

Objectives and Purpose:

The purpose of this study is to:

  1. Determine if oncogenic markers are indeed present in human milk.
  2. Compare the presence of oncogenic protein markers in the milk of mothers at low and high risk for breast cancer.
  3. Compare the change in oncogenic protein markers over time in the milk of mothers at low and high risk for breast cancer.
  4. Determine the presence of Human Papilloma Virus in human breast milk in low and high risk breast cancer groups.


It is important to understand that human milk contains numerous components, including a vast amount of maternal living breast cells, largely derived from the lactogenic tissues of the breast. In essence, it is an almost perfect biopsy of the woman's breast. Thus, milk provides a beautiful picture of the cellular components of the lactating breast. In this study, we will use this vast network of cells to derive information about the presence of oncogenic antigens, and even the HPV virus. We already have preliminary information that the breast cells from a woman with a family history of BRCA1, contains a large amount of some cancer antigens. This data led us to try and determine the presence of other well-known oncogenic markers in breast milk. As far as we know, this has only been done to a limited degree in the literature.

Pregnancy, lactation and breast remodeling has long been shown to alter the cell structure of the breast, particularly the epithelial and ductal system. Multiple studies have shown that support the theory that this process may confer risk reduction for breast cancer as a function of duration of breastfeeding. In essence, breastfeeding reduces your risk of breast cancer. Therefore, we are requesting single milk samples from all kinds of mothers. We will stratify each mom according to her risk. To do this we’ll ask you to take an online evaluation, which will suggest if you are at high or low risk of getting breast cancer. Then we will simply ask for a 1-6 milk samples.

We will ship you a collection tube and we will pay for the return postage.

So if you fit the inclusion criteria below, please let us know of you willingness to participate in this important study.

Subject Selection:

Inclusion Criteria

a) Breastfeeding mother >18 years of age less than 6 months postpartum
b) Women who are at high risk, i.e more than 5% on 10-year breast cancer risk, in the Tyrer Cuzick model or past history of breast cancer
c) Mothers with low risk (< 5% as control).
d) Mothers with an infant 37 weeks gestation or greater.

Exclusion Criteria

a) Women who are pregnant
b) Women who are not breastfeeding
c) Women at consent, who are > 6 months post partum
d) Women consuming anti-viral medications, corticosteroids, or any other immunosuppressant drugs

So if you fit the inclusion criteria, please contact my Clinical Research Center staff for more information: 806-414-9742

Thomas W. Hale R.Ph.,Ph.d.
InfantRisk Center
Texas Tech University School of Medicine