STAR is Under Way at M. D. Anderson
First Enrollee Gives Why's of Participating

If one step begins the journey of a thousand miles, Mary Watson-Ellyson hopes this first pill will start her on the road to breast cancer prevention - and peace of mind for women everywhere.

Watson-Ellyson is the first participant to begin taking a drug for the Study of Tamoxifen and Raloxifene (STAR) at The University of Texas M. D. Anderson Cancer Center. The National Cancer Institute, funding the nationwide five-year study to determine the best drug to prevent breast cancer in women at high risk, opened STAR enrollment in May. This is one of the largest breast cancer prevention studies conducted to date.

"Breast cancer crosses my mind several times a month, usually when I hear of a friend or co-worker who's been diagnosed," says Watson-Ellyson, who was saddened when a 36-year-old co-worker died of breast cancer recently, leaving two young children motherless.

"Whenever a friend is diagnosed with breast cancer, I always think, `why them?'" says the 57-year-old Continental Airlines ticket agent, on special assignment in the airline's President's Club in Houston.

M. D. Anderson is one of 400 participating centers that expect to enroll 22,000 post-menopausal women at increased risk for developing breast cancer. Watson-Ellyson is one of 400 women that M. D. Anderson expects to participate in STAR.

Because of her participation, every day for the next five years Watson-Ellyson will repeat her evening ritual, with one small addition. She will take a shower, brush her teeth, take her vitamins - and take her STAR pill.

It's just that simple, as is her reason for participating.

"This research gives us hope," she says.

No one, not even her M. D. Anderson research physicians and nurses, know which drug - tamoxifen or raloxifene - she will take for the next five years.

Her can-do attitude, apparent in her bright smile and easy laugh, is one reason she decided to participate.

"Sitting around worrying is worse for you. My attitude is that I'm not going to get breast cancer," says the mother of three grown sons. Her husband, Hershel, and sons support her decision to help researchers as they continue efforts to combat breast cancer.

"Years ago when I joined the Breast Cancer Prevention Trial, I felt like it was my contribution to womankind," she says.

An important part of STAR will be to compare the long-term safety of raloxifene and tamoxifen in women at increased risk for breast cancer, says Dr. Therese Bevers, principal investigator of STAR at M. D. Anderson.

"Tamoxifen is a medically proven intervention, but is not perfect," Dr. Bevers says. "Women who are at an increased risk of breast cancer need options for preventing this disease with a minimum of side effects, and STAR is a concerted effort to find one."

Watson-Ellyson is eligible to participate in STAR because researchers have determined that she is at high risk of developing breast cancer. In addition to Watson-Ellyson's mother being diagnosed with breast cancer at age 62, her sister developed breast cancer at age 47, and died at age 52.

"My sister dealt with it for five years. Following her lumpectomy, she remarried, traveled the world and lived in Denmark. She lived her life to the fullest," says Watson-Ellyson of her sister, who had two daughters and a son.

"Breast cancer scares me a lot more for my two nieces than for me. My sister had breast cancer before menopause," she says, aware that heredity plays a bigger part in breast cancer risk for women diagnosed before menopause.

In addition to breast cancer prevention investigations, more help is available for women who may be at higher risk for breast or ovarian cancers.

The Genetic Risk Assessment Clinic in M. D. Anderson's Cancer Prevention Center offers genetic counseling and testing for women and men who are interested in learning whether they carry a genetic change that increases their risk for several types of cancer. In addition to breast and ovarian, genetic counseling and testing is available for colorectal, thyroid and more.

"My heart just broke for my mom when she developed breast cancer. She had always dreaded getting it, ever since her sister was diagnosed with breast cancer. But my mother wasn't very good about going to the doctor. She didn't participate in screening exams. I don't know if she ever had a mammogram."

True to her upbeat, positive demeanor, Watson-Ellyson says she feels lucky that she hasn't developed breast cancer, and she hasn't allowed herself to worry too much about it.

She actively takes charge of her health by participating in regular cancer screening and early detection examinations.

"I've always gone for yearly mammograms. Following my hysterectomy, I had Pap tests every six months. I've participated in breast cancer screening for nearly 20 years. I've always been health-conscious. In the early 1970s, my doctor recommended that I become active in screening exams," she says.

Participating in breast cancer research was a natural step for her, says Watson-Ellyson. Her decision to participate in the first study, BCPT, was based on the disease of her sister and mother.

"I wanted to be a part of STAR because this study is a continuation of BCPT," Walton-Ellyson says.

When the NCI halted the BCPT study in May 1998, because of stunning findings that tamoxifen could prevent breast cancer, BCPT participants learned for the first time whether they had been taking tamoxifen or a placebo.

"I found out I was on placebo. For the last five years, I hadn't had any of the benefit of reduced risk of osteoporosis or heart disease, which tamoxifen can provide," she says.

Women who choose to participate in STAR are randomly assigned to receive either 20 milligrams of tamoxifen or 60 milligrams of raloxifene daily for five years and will have regular follow-up examinations, including mammograms and gynecologic exams.

"With STAR, I definitely will be getting a drug, either tamoxifen or raloxifene," Watson-Ellyson says.

Information about the safety of raloxifene is limited compared to the data available on tamoxifen, Dr. Bevers notes. Raloxifene was approved in December 1997 by the FDA to prevent osteoporosis and has been in clinical trials for about five years. Tamoxifen has been approved by the FDA for more than 20 years to treat women with breast cancer, and it has been in clinical trials for about 30 years.

Women taking raloxifene in studies of osteoporosis have had an increased chance of developing a deep vein thrombosis or pulmonary embolism similar to the risk seen with tamoxifen. In these studies, raloxifene did not increase the risk of endometrial cancer.

For more information, call the "STAR line" at M. D. Anderson at (713) 792-8064.

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©2006 Texas Medical Center

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