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Over 6,000 women at high risk of breast cancer have already
enrolled in
the STAR clinical trial , and researchers are
hoping that another 16,000 women will join within the next few
years. The STAR (Study of Tamoxifen and Raloxifene) clinical
trial is a national trial run by the National Surgical Adjuvant
Breast and Bowel Project (NSABP). STAR is designed to determine
whether the drug
raloxifene (brand name, Evista) is as
effective as the drug tamoxifen (brand name, Nolvadex) in
preventing breast cancer.
Tamoxifen, an antiestrogen, has recently been approved by the
U.S. Food and Drug Administration (FDA) for women at high risk of
developing breast cancer. Research prior to FDA approval showed that
tamoxifen can reduce the chances of developing breast cancer by 49%
in women at high risk. Raloxifene, also an anti-estrogen, is
FDA approved to help treat and prevent
osteoporosis, a degenerative bone disease.
Early research has shown that raloxifene may help prevent breast
cancer and could have fewer side effects than tamoxifen.
Side effects of tamoxifen may include:
- Hot flashes
- Vaginal dryness
- Unusual vaginal discharge or bleeding
- Irritation of skin around the vagina
Tamoxifen also increases a woman's chances of developing
serious health problems including:
- Endometrial cancer (cancer of the lining of the uterus)
- Deep vein thrombosis (blood clots in large veins,
particularly in the legs)
- Pulmonary embolism (blood clot in the lung)
- Possibly stroke
The STAR trial began one year ago, and recruitment will
continue for up to four more years. STAR is a randomized,
double-blind study that will include 22,000 post-menopausal women
(age 35 or older) who are at increased risk for developing breast
cancer as determined by their age, family history of breast cancer,
personal medical history (such as a diagnosis of
lobular carcinoma in situ
), age at first menstrual
period, and age at first childbirth.
Candidates must go through a process known as informed
consent, during which they learn about the potential benefits and
risks of tamoxifen and raloxifene before deciding whether to
participate in STAR. The women who choose to enroll are randomly
assigned to a regimen of either 20 milligrams of tamoxifen or 60
milligrams of raloxifene daily for five years. All participants will
receive close follow-up examinations, including
mammography and physician performed
clinical breast
exams on a
regular basis for at least seven years. Women who participate
in STAR will not be charged for the cost of either tamoxifen or
raloxifene.
More than 500 centers in the United States, Canada, and
Puerto Rico are enrolling women in STAR.
Click here for additional information on eligibility requirements and
how to enroll in STAR.
Additional Resources and
References
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