P-2: The Study of Tamoxifen and Raloxifene (STAR) Prevention Trial
P-2, the Study of Tamoxifen and Raloxifene (STAR), will determine whether raloxifene is more or less effective than tamoxifen
in reducing the incidence of invasive breast cancer in postmenopausal women who are at increased risk for developing it.
Secondary goals of the STAR study include determining whether raloxifene reduces:
- the rate of endometrial cancer compared to tamoxifen;
- incidence of intraductal carcinoma in situ;
- endometrial cancer;
- ischemic heart disease; and
- incidence of hip, spine and wrist fractures.
In addition, the STAR study will compare the toxicity of tamoxifen and raloxifene and measure each participant's quality of
life.
Postmenopausal women may be eligible to participate in the study if:
- their projected five-year probability for developing invasive breast cancer is at least 1.66 percent. The five-year probability
of developing invasive breast cancer will be determined by
NSABP's breast cancer risk assessment profile
.
- they have a history of lobular carcinoma in situ (LCIS). LCIS is a pre-cancerous condition.
Tamoxifen has been used to treat breast cancer since it was first approved by the FDA in 1976. In 1998, another NSABP study
revealed that tamoxifen also prevents breast cancer recurrences in many women.
In a study of postmenopausal women with osteoporosis, raloxifene was shown to reduce the incidence of breast cancer compared
to a placebo group.
Women who participate in the STAR study will receive breast exams every six months and annual mammograms, gynecological exams
and lab work.
STAR is a study of the
National Surgical Adjuvant Breast and Bowel Project (NSABP).
For more information, please call (215) 456-7215.
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