Forsyth Medical Center 
Cancer Research
STAR Breast Cancer Prevention Trial
| The Study of Tamoxifen and Raloxifene, or STAR, is one of the largest breast cancer prevention clinical trials ever. Below are some frequently asked questions about the STAR trial. |
What is the Study of Tamoxifen and Raloxifene (STAR)?
The Study of Tamoxifen and Raloxifene (STAR) is a clinical trial designed to see how the drug raloxifene compares with the drug tamoxifen in reducing the incidence of breast cancer in women who are at an increased risk of developing the disease.
What is tamoxifen?
Tamoxifen has been used for more than 20 years to treat patients with breast cancer. This drug works against breast cancer by interfering with the activity of estrogen, a female hormone that promotes the growth of breast cancer cells.
What is raloxifene?
Raloxifene was approved in December 1997 by the FDA for the prevention of osteoporosis in postmenopausal women. This drug is being researched because large studies testing its effectiveness against osteoporosis have shown that women taking the drug developed fewer breast cancers than women taking a placebo.
Who is eligible to participate in STAR?
Women at increased risk for developing breast cancer, who have gone through menopause and are at least 35 years old, can participate in STAR.
What factors are used to determine increased risk of breast cancer for the participants?
- Current age
- Number of first-degree relatives (mother, daughters, or sisters) diagnosed with breast cancer
- Whether a woman had any children and her age at her first delivery
- The number of breast biopsies a woman has had, especially if the tissue showed a condition known as atypical hyperplasia
- the woman's age at her first menstrual period
What are the common side effects of tamoxifen and raloxifene?
Tamoxifen and raloxifene can cause adverse effects in some women, just as other medications do. The most common effects are hot flashes and vaginal symptoms, including discharge, dryness, or itching. Leg cramps, constipation, pain with intercourse, sinus irritation or infection, or problems controlling the bladder upon exertion are also possible side effects. Treatments that may minimize or eliminate most of these side effects will be available to the participants.
