Featured Clinical Trial
Making Decisions about Cancer Prevention Medications for Breast Cancer
Name of the Trial
Study of Factors Influencing Decision Making about Chemoprevention Agents in Women at Increased Risk for Breast Cancer (NSABP-DMP-1). See the protocol summary.
Dr. Christine Holmberg and Dr. Angela Fagerlin, National Surgical Adjuvant Breast and Bowel Project
Why This Trial Is Important
Breast cancer is the second most common cancer among women in the United States, with more than 200,000 new cases diagnosed each year. Some risk factors for developing breast cancer include age, race, prior breast cancer or breast carcinoma in situ, number of first-degree relatives with the disease, age at onset of menstruation, whether a woman has given birth and at what age, and a history of breast biopsies.
With a risk assessment tool, such as the Gail model, these factors can be used to determine whether a woman is at higher than average risk of developing breast cancer. The Gail model calculates the probability that a woman will develop the disease over the next 5 years and over her lifetime. Women with a 5-year risk of 1.7 percent or higher are considered to be at increased risk and are eligible to take the drug tamoxifen to reduce that risk.
Tamoxifen and a similar-acting drug called raloxifene (Evista) are selective estrogen receptor modulators, or SERMs. These drugs block estrogen's ability to stimulate the growth of breast cancer cells. Large chemoprevention studies have shown that tamoxifen and raloxifene substantially reduce the risk of breast cancer in women at increased risk of this disease.
By some estimates, more than 10 million American women qualify to use a SERM for breast cancer prevention based on their level of risk. Despite proven benefits, however, most women at increased risk of breast cancer either choose not to take these medications or simply do not come to a decision, even after discussing the drugs' risks and benefits with a health care provider and perceiving a personal high risk of disease. Cancer prevention researchers are eager to understand how women make choices about whether to take these drugs for cancer prevention.
In this study, women age 35 or older who discuss the use of a SERM for breast cancer prevention with a health care provider will be asked to complete a questionnaire about their discussion and whether they have come to a decision about using a SERM for risk reduction. Women who indicate that they have made a decision will be asked to complete a second questionnaire about their decision-making process. The second questionnaire will be mailed to women who have not indicated that they have made a decision within 6 months of completing the first questionnaire.
"We want to know how people actually make decisions—what's important for their decision-making," said Dr. Holmberg. "[Researchers and health care providers] are focusing on numbers all the time, but increasingly we know that numbers are not the deciding factor. We need to be sure that we present numbers appropriately, but we also need to understand what other factors play a role in decision-making" about breast cancer chemoprevention.
"We are interested in the decision-making process, so we are fine with any woman who decides she is not going to take a SERM," she explained. "We just want to know, how did you make your decision?
"Our ultimate goals for this study are to use the information we collect to guide us in making better decision aids, and finding out what people's needs are for chemoprevention drugs so that we know what type of drugs we need to focus our efforts on," Dr. Holmberg concluded.