Clinical Projects

A primary goal of our clinical work is to prevent breast cancer. To achieve this goal, we work intensively on lifestyle factors and study medicines that may help prevent many thousands of cases of breast cancer. This is especially important in special populations, such as Ashkenazi Jewish women with a personal or a family history of breast, ovarian or other cancers.

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Cancer Prevention

Dr. Merajver served as the principal investigator for three breast cancer chemoprevention trials designed study the benefits of drugs given to women without cancer in order to help avoid a cancer diagnosis.

Breast Cancer Prevention Trial (BCPT)

BCPT was designed to test whether the drug tamoxifen can prevent breast cancer in women who are at an increased risk of developing the disease. From 1992-1997, 13,388 women aged 35 and older were enrolled at more than 300 centers across the United States and Canada. The results revealed that tamoxifen prevented estrogen receptor positive breast cancers and reduced the risk of an invasive cancer in women at increased risk by approximately 45%. Based on these encouraging results, additional trials were conducted.

Study of Tamoxifen and Raloxifene (STAR)

STAR was a clinical trial designed to test how the drug raloxifene compares with the drug tamoxifen in reducing the incidence of breast cancer in postmenopausal women who are at increased risk of the disease. A secondary goal was to identify any differences in side effects of the two drugs. One of the largest breast cancer prevention studies ever, STAR took place at more than 500 centers across the United States, Canada, and Puerto Rico. The results reaffirmed the prevention effects of both tamoxifen and raloxifene; the raloxifene group experienced fewer cases of endometrial cancer and blood clots, but the differences were very small. As a result, we recommend both drugs, depending on a patient's specific circumstances.

Study of Low dose Tamoxifen

This trial is designed to study whether low dose Tamoxifen can prevent breast cancer in female survivors of childhood or young adult Hodgkin's lymphoma who underwent mantle radiotherapy as part of their lymphoma treatment (and are, thus, considered to have moderate to high risk for breast cancer). We are excited to cooperate with several other centers on this project.

Comprehensive Risk Evaluation and Management for Carriers of High Susceptibility Genes

The Breast and Ovarian Cancer Risk Evaluation Program at the University of Michigan Comprehensive Cancer Center provides individuals with an accurate assessment of their personal risk for developing breast and other related cancers and also offers a plan for follow-up and preventative care. We started this program in 1994 and is thus one of the oldest (perhaps the oldest) in the world. We approach every patient as a whole person, not as someone who is just at risk for breast cancer; our dialogue with the patient and the family focuses on all health aspects and lifestyle actions to help prevent cancer and other chronic diseases.

The process is outlined below:

  1. A detailed family history is obtained, documenting cancer types and age of diagnosis, along with birth defects, consanguinity, and other medical conditions.
  2. Pathology reports are obtained and reviewed for family members with a diagnosis of cancer.
  3. Patient information is obtained, regarding patient's age, age of menarche, number of breast biopsies and results, age of first live birth, and number of first degree relatives with a diagnosis of breast cancer.
  4. The patient is then scheduled for genetic counseling.

Genetic counseling

Genetic counseling is a communication process that deals with the emotional impact of having or being at risk for a genetic condition. A patient may have many different reasons for seeking a risk assessment consultation, including:

  1. known risk for developing breast cancer
  2. would like to know if gene testing is a viable option given family history
  3. has interest in risk reduction options - i.e. diet and exercise
  4. would like to evaluate risks and benefits of estrogen replacement therapy
  5. has interest in chemoprevention - i.e. tamoxifen
  6. has interest in prophylactic surgery - i.e. mastectomy and/or oophorectomy
  7. has interest in genetic research
  8. has interest in chemoprevention clinical trials

What happens at the genetic counseling consultation?

  • patient's family history is reviewed, highlighting cancer occurrence
  • patient is educated in basic genetic principles as applied to breast and ovarian cancer
  • patient is presented with the known cancer risk factors
  • the patient's individualized risk is discussed, which is based on family history and personal risk factors
  • the patient is instructed in proper breast self-examination technique and behaviors thought to diminish and increase risk of various cancers are discussed
  • the patient is educated regarding availability of genetic testing and current research
  • protocols (clinical trials)
  • the patient is presented with an individualized plan for follow-up care
  • the patient receives recommendations with respect to lifestyle issues and choices

What happens after the consultation?

  • the referring physician is informed by letter that the consultation has taken place and is provided with the recommendations for continuing care
  • the patient is sent a confidential summary letter that reviews the genetic counseling session
  • long term follow-up is ascertained through periodic mailings and/or telephone
  • conversations
  • some patients with specific concerns are routinely followed in our clinic

Risk Communications

Dr. Merajver is also involved in research related to Risk Communication and is actively involved in a number studies.

Development of a Family Communication and Decision-support Intervention for Women that Carry a BRCA1 or a BRCA2 Mutation and Their At-Risk Family Members

This study aims to develop a family communication and decision support intervention to facilitate dissemination of information about hereditary breast and ovarian cancer as well as genetic testing for women that carry a BRCA1 or a BRCA2 mutation to their female relatives who have >10% chance of carrying the same mutation.

Hereditary breast/ovarian cancer risk and family functioning

The study will examine the impact of individual and familial factors on the decision to pursue genetic testing among women who are at high-risk for carrying a genetic mutation in the BRCA1 and BRCA2 genes. The goals of this study include:

1. Examination of the influence of illness representations of hereditary breast/ovarian cancer and family functioning on women's decision to utilize genetic testing for BRCA1 and BRCA2 genes.

2. Determination of whether family functioning modulates the relationship between women's illness representations of hereditary breast/ovarian cancer and their decision to utilize genetic test for BRCA1 and BRCA2 genes.

Development and Evaluation of a Breast Cancer Genetics Education Tool and Decision Aid

This study aims to create an easily disseminated and effective patient-friendly Web-based application using tailored educational materials, personalized cancer risk estimates, and validated risk communication techniques. We hope this will be an effective adjuvant to traditional breast cancer genetic counseling services. Such technologies are needed to expand the reach and improve the cost-effectiveness of breast cancer genetic services and are part of a growing movement within clinical care to provide validated patient decision aids.

Identification and analysis of families with genetic susceptibility to breast and/or Ovarian cancer

This study is designed to identify novel breast and ovarian cancer susceptibility genes by looking for genes that may be involved in the development of cancer. These genes may be implicated in the development of certain breast and/or ovarian cancer, which can run in families.

Comparing Male and Female BRCA Mutation Carriers' Communication of their BRCA Test Results to At-Risk Relatives and Spouses/Partners

Dr. Merajver is also very active in student research, and is a mentor to many graduate student research projects involving risk communication, including this recent study.