Click It for the Cure

Breast Cancer Treatment is not always the same - Japan's approach

More Women getting double mastectomies

The value of exercise during radiation therapy for breast and prostate cancer.

Hormones Used In Breast Cancer Fight

Low Fat Diets May Help Some Dodge Cancer

Breast Cancer Drop Tied to Hormones

Abortion Pill Thwarts Breast Cancer Gene

Prempo Suits

Study:Estratest Doubles Breast Cancer Risk

Device Detects Cancer Early

NY STUDY No Environmental Link to Cancer

Study Links Estrogen, Breast Cancer RIsk

Study:Pumping Iron Helps Cancer Survivors

Vitamin D may cut breast cancer risk

Court:British NHS Wrong in Cancer Case

Sisters of breast cancer victims studiedBanner

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Breast Cancer Facts

One in eight women or 12.6% of all women will get breast cancer in her lifetime.

Breast cancer risk increases with age and every woman is at risk.

Every 13 minutes a woman dies of breast cancer.

Seventy-seven percent of women with breast cancer are over 50.

More than 1.7 million women who have had breast cancer are still alive in the United States.

Breast cancer is the leading cause of cancer death in women between the ages of 15 and 54, and the second cause of cancer death in women 55 to 74.

Seventy-one percent of black women diagnosed with breast cancer experience a five-year survival rate, while eighty-six percent of white women experience five-year survival.

The first sign of breast cancer usually shows up on a woman's mammogram before it can be felt or any other symptoms are present.

Risks for breast cancer include a family history, atypical hyperplasia, delaying pregnancy until after age 30 or never becoming pregnant, early menstruation (before age 12), late menopause (after age 55), current use or use in the last ten years of oral contraceptives, and daily consumption of alcohol.

Early detection of breast cancer, through monthly breast self-exam and particularly yearly mammography after age 40, offers the best chance for survival.

Ninety-six percent of women who find and treat breast cancer early will be cancer-free after five years.

Over eighty percent of breast lumps are not cancerous, but benign such as fibrocystic breast disease.

Oral contraceptives may cause a slight increase in breast cancer risk; however 10 years after discontinuing use of oral contraceptives the risk is the same as for women who never used the pill.

Estrogen replacement therapy for over 5 years slightly increases breast cancer risk; however the increased risk appears to disappear 5-10 years after discontinuing the use of estrogen replacement therapy.

You are never too young to develop breast cancer! Breast Self-Exam should begin by the age of twenty.

American Cancer Society
National Cancer Institute
Komen Foundation

Getting tested or treated for a life-threatening disease is nerve-racking for anyone, but it can be all the more so when outside of your home country.

Japan's approach to breast cancer, with the annual death toll exceeding 10,000 (lower than typical rates in the West) is unique to some degree, what with the country's egalitarian health-care system and particularly its long-standing custom of surgeons doing all the work. Experts say that surgeons here do everything from making a diagnosis to performing surgery to even prescribing medication.This is different from practices in the West, especially in the United States, where treatment is divided among a team of specialists that include radiologists, oncologists, surgeons and in later stages of cancer palliative-care specialists, says Hirofumi Mukai, a breast oncologist at the National Cancer Center Hospital East in Chiba Prefecture.

"The Japanese practice has some merit, in that there is a sense of continuity in the treatment," Mukai says. "Many Japanese feel more comfortable dealing with one doctor who knows everything about them."

But even the best surgeons cannot specialize in all aspects of care, so doctors who are strong in some areas, such as diagnostic skills or chemotherapy, can be weak in other areas, Mukai says.

Health-care systems vary from country to country. The good news in Japan is that the country has a national health insurance system, which requires everybody to be insured, either as individuals or through their employer. This universal care system provides treatments that are approved by the government relatively cheaply. The bad news is that unapproved treatments, including ones common in the West, are out of reach for most patients.

Take, for example, a drug called trastuzumab, more commonly known under the trade name of Herceptin. Herceptin is an antibody used in the treatment of breast cancer, which attacks the HER2 protein that can fuel tumors. It has "a big influence" on patients here, Mukai says, because it is known to reduce the recurrence of breast cancer by half and is the only "targeted therapy" drug for breast cancer approved in Japan. Targeted therapy refers to medications that block the growth of cancer by interfering with the molecules needed for tumor growth, rather than simply attacking rapidly-dividing cells.

In Japan, Herceptin is covered by insurance only after the cancer returns or spreads to different parts of the body; Mukai says that in the United States and many parts of Europe, the drug is available for use in post-surgery treatment to prevent the cancer from coming back.

Herceptin will probably be available insurance coverage for such usage next year, but currently those who want to have the drug prescribed must pay 3 million for the full-course, yearlong treatment, which excludes the cost of consultations with doctors and other fees, according to Mukai. What is worse, under Japanese law, patients who receive uninsured treatments such as Herceptin have their insurance coverage cut off for all other related procedures, because the government does not allow patients to mix insured and uninsured treatments. This could change, though, following a recent district court ruling that deemed such practices unlawful.

In Japan, more women are now having only parts of their breast removed and are keeping non-cancerous areas, whereas in the United States, the trend is going in the opposite direction. An October study published in the Journal of Clinical Oncology found that 4.5 percent of 152,755 breast-cancer patients examined had their unaffected breast surgically removed along with their affected breast in 2003, up from 1.8 percent in 1998. Todd Tuttle, the study's lead author and chief of surgical oncology at the University of Minnesota Medical School, has been quoted in the New York Times saying: "The comment patients make is, 'I just want to be done with it.' They never want to have another mammogram again; they never want to have another biopsy again."

Seigo Nakamura, director of breast surgical oncology and director of the Breast Center at St. Luke's International Hospital in Tokyo, says that, unlike in the United States, a double mastectomy immediately followed by breast reconstruction surgery is not a treatment option here because breast construction is not insured and, besides, few reconstruction experts exist.

Another disadvantage for patients in Japan is that genetic testing for BRCA1 and BRCA2 genes, inherited mutations of which can greatly increase a woman's breast-cancer risk, is not covered by insurance, either. St. Luke's Breast Center is one of the few places that offer the test, but at a hefty cost of 200,000, Nakamura says.

The upside is, for anyone interested in a screening for breast cancer, most municipalities now offer subsidized mammography X-ray tests for women aged 40 or older. Screening programs vary from city to city, cover different age groups and are offered at different intervals. Most cities offer an X-ray exam every two years, either free of charge or for a nominal fee of 500 or 1,000. Some provide a combination of mammography and, if requested, screening using ultrasound.

Though both mammography and ultrasound screening can detect small tumors, some experts say ultrasound is preferred for those younger than 40 because the high density of mammary glands in women in their 30s makes it difficult for cancerous tissues to be found. Ultrasound is also widely used during surgery, as many Japanese surgeons are skilled at operating ultrasound machines and removing tumors on the spot, says Nakamura.

"That's probably the only thing we can be proud of as being advanced in the world," he says. by Tomoko Otake

10/23/2007 More women who have cancer in only one breast are getting both breasts removed, says research that found the trend more than doubled in just six years. It's still a rare option: Most breast cancer in this country is treated by lumpectomy, removing just the tumor while saving the breast.

But the new study suggests 4.5 percent of breast cancer surgery in 2003 involved women getting cancerous and healthy breasts simultaneously removed, a 150 percent increase from 1998 _ with no sign that the trend was slowing.

Young women are most likely to choose the aggressive operation, researchers report Monday in the Journal of Clinical Oncology.

The concern is whether they're choosing in the heat of the moment _ breast cancer surgery often is within two weeks of diagnosis _ or with good understanding of its pros and cons.

"Are these realistic decisions or not?" asks Dr. Todd Tuttle, cancer surgery chief at the University of Minnesota, who led the study after more women sought the option in his own hospital.

"I'm afraid that women believe having their opposite breast removed is somehow going to improve their breast cancer survival. In fact, it probably will not affect their survival," he said.

The initial tumor already may have sent out seeds of spread to key organs, Tuttle explained.

But removing the remaining healthy breast does greatly lower, although not eliminate, chances of a new cancer developing on the opposite side.

Don't underestimate the peace of mind that brings, said Trisha Stotler Meyer of Vienna, Va., who had her breasts removed three weeks ago.

"Doctors are not up at night crying" in fear of their next mammogram, said Meyer, 37, who went back for a double mastectomy after her initial cancer surgery. "I don't want to have to deal with the stress."

Meyer is far from alone.

In a single day last week, Dr. Shawna Willey of Georgetown University's Lombardi Cancer Center had two patients seek the operation.

One needed her entire cancerous breast removed, and immediately asked to have the healthy one removed, too. Another woman had recently undergone a lumpectomy and was sick from chemotherapy _ and returned to ask that both breasts be fully removed.

"Her perception is, 'If I have my breasts taken off, I never have to do this again,'" said Willey, who asked the woman to see a counselor and finish chemo before deciding.

"I can understand that point of view," she added. "But I always tell them, it's not a guarantee."

The American Cancer Society estimates 178,480 U.S. women will be diagnosed with breast cancer this year. About 40,460 will die of it.

Some women at high risk, because of notorious breast cancer genes or family history, choose preventive mastectomies before cancer ever strikes.

Tuttle's study is the first national look at how many women choose to remove both a diseased and healthy breast together.

He used a government cancer registry that covers 16 regions, a representative sample of the U.S. population, to track more than 150,000 breast cancer surgeries between 1998 and 2003.

Tuttle calculated that lumpectomies accounted for almost 60 percent of those surgeries in 2003. Lumpectomies have gradually increased since they were proven just as effective as breast removal for early cancer in 1991.

The surprise: Single mastectomies remain the No. 2 option but are dropping _ while double mastectomies, although uncommon, were on the rise for every stage of cancer. Even women who qualify for anti-hormone drugs that greatly protect the remaining breast were as likely to choose removal as women with harder-to-treat tumors.

Why? Tuttle is planning a new study to tell, and to see if candidates are warned about such risks as infection that increase with the bigger surgery.

Meyer, the Virginia woman, had time to fully consider the option. She was diagnosed with cancer in January 2005, shortly after her son's birth. At first, she was content with a lumpectomy, followed by chemotherapy and radiation. But she didn't qualify for protective anti-hormone drugs. And then in March, Meyer found a lump in her healthy breast. It wasn't cancer but a cyst that would wax and wane, making for tense checkups.

"It really freaked me out," Meyer said. "It was at that moment that my breasts became like tonsils. I don't need them anymore. They're gone."

Georgetown's Willey says better reconstructive surgery is partly spurring the trend. Still, she often encourages women to wait to remove the second breast, as lining up reconstruction sometimes dangerously delays treating the cancer.

"When I was younger ... I really tried to argue with patients and talk them out of it," Willey said. Now, if they've weighed the options, she doesn't.

"I can't recall a single patient who tells me they regret that decision."


The value of exercise during radiation therapy for breast and prostate cancer

 Submitted by Dr. Carol Kornmehl on February 25, 2007 - 2:28pm. 

 Complementary medicine integrates non-Western treatment methods into mainstream medical practice. Examples include light exercise, guided imagery, massage, yoga, reiki, tai chi, acupuncture, music therapy, and art therapy.


Fatigue is a common symptom during cancer treatment, such as chemotherapy and radiation therapy. It can stem from the underlying illness, insomnia/sleep deprivation, anxiety, and/or the cancer treatment itself. Helping people manage and reduce fatigue is an important component in enhancing their overall well-being. After all, oncologists strive to treat the whole person and not just the disease.

The mechanism of fatigue in radiation therapy is not known. Often, it is not purely radiation treatment induced, but rather, is due to one or more of the factors outlined above.

In people with breast and prostate cancer, the National Cancer Institute undertook a randomized controlled study of cancer related fatigue in 38 individuals. 27 were women with breast cancer and 11 were men with prostate cancer. All received at least 30 radiation treatments, five days a week for six weeks.

Baseline tests to assess fatigue, strength, and cardiovascular heath were performed before the people received radiation therapy. The study compared a half the people in the group who followed an exercise program to the half who were randomized to receive radiation therapy without exercise therapy.


The exercise group was required to take walks daily and to try to increase the number of steps taken each day. They wore pedometers and kept a diary. In addition, they were assigned to complete 11 resistance band exercises daily, performing one set of eight to 15 repetitions daily and gradually increasing to three to four sets. Results revealed an 82% increase in the number of steps walked daily and the use of resistance bands an average of 3 1/2 days per week for 20 minutes at a moderate intensity level.


The mechanism by which exercise alleviates fatigue is not clear. Although this study is small and more clinical trials will be helpful, the results suggest that when exercise is non-burdensome, safe and feasible, it serves as an inexpensive, valuable tool in improving the quality of life of cancer survivors.

For more information about radiation therapy, visit , the website of The American Society of Therapeutic Radiology and Oncology.

Dr. Kornmehl is a board certified radiation oncologist and author of the critically acclaimed consumer health book, "The Best News About Radiation Therapy" (M. Evans, 2004). Her website is 


2006-12-17   Robin Khadduri gets monthly shots of a drug that blocks the male hormone testosterone and is often used to treat prostate cancer.

But Khadduri doesn't have a prostate or much testosterone either. She and many other young women are getting the drug for breast cancer as part of a super-hormone treatment that new research suggests may improve their survival odds.

This chemical equivalent of ovary removal has one big advantage over surgery: it's not permanent, so it may preserve a woman's ability to have children.

In premenopausal women, the drugs suppress the pituitary gland, which produces hormones that control the ovaries and cause a woman to have a period every month. Side effects of this induced early menopause are similar to those of natural menopause _ hot flashes, night sweats, etc., according to new research presented at the San Antonio Breast Cancer Symposium, which ended Sunday.

Women like Khadduri, who fear cancer's return, consider that a small price to pay.

The drugs include triptorelin, goserelin, leuprolide and buserelin, sold as Lupron, Zoladex, Prostap and other brands.

Such drugs have been around for 20 years and are used more in Europe than in the United States, where attention has focused more heavily on chemotherapy, said V. Craig Jordan of Fox Chase Cancer Center in Philadelphia, the scientist who developed tamoxifen, a mainstay hormone drug for preventing cancer recurrence.

"This has been like tumbleweed slowing gaining momentum," he said of ovarian suppression.

The drugs are most often used in two situations:

_ As an alternative to chemotherapy for women who have had surgery for small, hormone-fueled tumors and are considered at relatively low risk for recurrence.

_ As a way to keep the ovaries suppressed in women whose periods return after temporarily stopping during chemotherapy.

"They call it 'chemopause,'" said Khadduri, who is getting triptorelin shots now. The 37-year-old mother of three from Needham, Mass., was found in January to have two small tumors that had spread to at least one lymph node but not extensively.

"The thing I liked about it is, it was not permanent," she said of the treatment. "It wasn't like I was having surgery to have my ovaries removed. If the side effects were too much, I could stop."

Her physician, Dr. Eric Winer of the Dana-Farber Cancer Institute in Boston, enrolled her in one of three large experiments currently under way to test this approach.

"It's the oldest of all treatments," but doctors still do not know how much benefit it gives or how best to use it, Winer said.

In the latest research, Jack Cuzick of the Wolfson Institute of Preventive Medicine in London combined results from more than a dozen studies involving 9,000 women from 1987 to 2001.

Those that tested ovary-suppressing drugs on top or in place of chemotherapy and standard hormone therapy with tamoxifen found a lower risk of recurrence after an average of seven years _ 24 percent versus 29 percent _ among women given the more intense treatment.

Such women also had a smaller risk of death _ 11 percent versus 13 percent.

A second report at the cancer conference reinforced the value of ovarian suppression.

Dr. Michael Gnant of the Medical University of Vienna in Austria reported that women whose periods did not return after chemotherapy had lower cancer relapse rates than those resuming menstruation.

"Additional hormone suppression may be advisable" to keep periods from returning, he said.


On the Net:

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2006-12-16   The first experiment ever to show that low-fat diets could help prevent a return of breast cancer now reveals, with longer follow-up, that the benefit was almost exclusively to women whose tumor growth was not driven by hormones.

That could be huge _ the new results suggest but cannot prove that these women might be able to cut their risk of dying by up to 66 percent with such diets.

"That's as great or better than any treatment intervention that we've given" for this type of cancer, which is notoriously hard to treat, said Dr. C. Kent Osborne of Baylor College of Medicine in Houston, who had no role in the study.

However, for women whose cancers are fueled by hormones _ the vast majority of breast cancer patients _ the diet change seemed to make little difference in the risk of recurrence or survival. Questions remained about whether those who did benefit truly were helped by cutting fat or by the weight loss that resulted.

"Maybe it raises as many issues as it answers," said John Milner, chief of nutrition science research for the National Cancer Institute, which paid for the first phase of the study.

Initial findings from the study were reported at a cancer conference in 2005 and will appear in this week's Journal of the National Cancer Institute. Updated results with longer follow-up on many of the original participants were presented Saturday at the San Antonio Breast Cancer Symposium.

The mixed results were a surprise because doctors had expected all women to benefit, said Dr. Rowan Chlebowski of the University of California at Los Angeles, who led the work.

Hormones might play such a strong role in some cancers that dietary changes have only weak impact on future risk, experts said.

The study involved 2,437 women with early stage breast cancer, average age 58, at 39 sites around the country. All had surgery followed by chemotherapy and five years of tamoxifen if their tumors were hormone-fueled.

At the start of the study, 29 percent of their calories came from fat _ 10 percent to 12 percent lower than the typical American diet. Doctors told 1,462 of them to continue their normal diets. The other 975 had counseling with dietitians to cut fat to around 20 percent of daily calories.

The diet group averaged 33.3 grams of fat a day compared to 51.3 grams for the others, and lost five to six pounds during the study.

Five years later, cancer had returned in 9.8 percent of the diet group and 12.4 percent of those on standard diets, which translated to a modest 24 percent lower risk for the group as a whole.

But the result barely reached statistical significance, meaning that the difference almost could have occurred by chance alone. The new results, with longer followup, put the difference for the overall group at 21 percent and even weaker statistically.

Researchers' ability to study the women beyond the first five years was hampered by the federal grant running out. Two charities _ the Breast Cancer Research Foundation and the American Institute for Cancer Research _ gave money so they could resume.

Ten of the original 39 study sites have provided complete information on their participants for an additional two years, and information on deaths is available for all women in the study, Chlebowski said.

The new results: 14 percent of women on low-fat diets and 17 percent of the others have had a recurrence or second cancer. About 8 percent of dieters and 10 percent of the others have died.

However, there was a huge difference in the subgroup of women whose tumors were fueled by neither estrogen nor progesterone. Only 6 percent on low-fat diets died compared with 17 percent of the others. That translated to 66 percent lower risk of death for those who trimmed fat.

Was the benefit due to weight loss, eating more fruits and vegetables or something else? Researchers do not know.

"When you change the diet, you're probably changing thousands of circulating proteins that could interact with other targets," like insulin, that might impact cancer risk in different ways depending on hormones, Chlebowski said.

"Excess calories, be they fat or otherwise, are associated with cancer risk," Milner said.

Some earlier studies did not find low-fat diets to reduce breast cancer risk. The new one's conclusion that some may benefit from substantially cutting fat "suggests that getting below a certain threshold of fat intake may be important," said Dr. JoAnn Manson, a women's health expert at Harvard-affiliated Brigham and Women's Hospital.

Chlebowski will help lead a new study in the United States and Canada that will start next year and test weight loss and increased exercise in addition to low-fat diets to try to reduce cancer risk in women whose tumors are helped to grow by estrogen.


On the Net:

Breast cancer meeting:

Cancer institute:


Breast Cancer Drop Tied to Hormones

2006-12-15   The millions of women who quit taking menopause hormones after a big federal study found that the pills raised the risk of breast cancer now have more reason to be glad they stopped.

A new analysis reveals that U.S. breast cancer rates plunged more than 7 percent in 2003 and strongly suggests that the reason is less hormone use.

"It's a big deal ... amazing, really," said one of the researchers, Dr. Rowan Chlebowski of Harbor-UCLA Medical Center in Los Angeles. "It's better than a cure" because these are cases that never occurred, he said.

About 14,000 fewer women were diagnosed with the disease than had been expected, researchers reported Thursday at the San Antonio Breast Cancer Symposium.

Cancers take years to form, so going off hormones would not instantly prevent new tumors. But tumors that had been developing might stop growing, shrink or disappear, so they were no longer detected by mammograms, doctors theorized.

Cases dropped most among women 50 and older _ the age group taking hormones. The decline was biggest for tumors whose growth is fueled by estrogen _ the type most affected by hormone use.

In fact, when both factors were combined _ older women with estrogen-positive tumors _ the drop was 12 percent.

The decline was seen in every single cancer registry that reports information to the federal government, and no big change occurred with any other major type of cancer. These are strong signs that the breast cancer decline is no statistical fluke or error.

A separate study by the American Cancer Society, currently in press with a medical journal, also documents the drop in cases. Lead author Ahmedin Jemal attributes two-thirds of it to a decline in hormone use and the rest to mammography use leveling off, resulting in fewer tumors being detected.

"We are really trying to look at the big picture," he said. "You cannot rule out the effect of screening."

Breast cancer is the most common major cancer in American women and the second leading cause of cancer deaths in women. About 213,000 new cases are expected to occur in the United States this year and more than 1 million worldwide.

Incidence in the United States rose almost 2 percent per year from 1990 to 1998, then began to slightly decrease, said Dr. Peter Ravdin of the University of Texas M.D. Anderson Cancer Center in Houston, who led the analysis presented at the Texas conference.

In July 2002, the federal Women's Health Initiative study was stopped after more breast cancers and heart problems occurred among women taking estrogen-progestin pills.

That led to new warning labels on the drugs and doctor groups urging women to use the lowest dose for the shortest time possible for hot flashes and other menopause symptoms.

Within a year, about half of women who had been taking hormones stopped. Prescriptions had been steady at around 22 million each quarter, but plummeted to 12.7 million in the last quarter of 2003, according to IMS Health, which tracks drug sales.

Breast cancer rates declined, too. In 2002, there were roughly 134 cases per 100,000 women _ a 2.5 percent drop from about 137 the previous year. In 2003, there were only 124 cases per 100,000 women _ about a 7 percent drop over 2002. That is the most significant decline in the breast cancer rate since records have been kept beginning in the 1970s.

Researchers saw an even stronger trend when they looked month-to-month. Cases dropped 6 percent in the first half of 2003 and 9 percent in the second half.

"Consistently across the entire year, there appeared to be a trend toward decrease," Ravdin said.

Estrogen-sensitive tumors declined twice as much as tumors that are not fueled by estrogen. The decline in incidence among women ages 50-69 was three times that of other age groups.

The numbers come from the National Cancer Institute's surveillance database, which uses cancer registries around the country to project national incidence and death rates.

When the 2003 numbers were first released a few months ago, they were grouped with 2001 and 2002 and portrayed as a leveling off of breast cancer after decades of steady rise. The big single-year drop was not pointed out.

"You don't want to overinterpret one point" without knowing whether it is a trend, said Kathy Cronin, a National Cancer Institute statistician who worked on the new analysis.

"The major health organizations have been cautious because of not wanting to call attention to something of this much interest to everyone prematurely," said Dr. Michael Thun of the cancer society.

Ravdin disagreed.

"It doesn't have to be a trend to be real," he said. "Such a rapid effect is most consistent with the idea that cancers that were already there ... were actually being stopped in their growth to the point where they would not be detected."

It is not known whether these tumors will regress and never become a problem or just take longer to show up, he said.

However, doctors already know that withdrawing hormones causes tumors to shrink. If a woman with estrogen-sensitive breast cancer has her ovaries removed, "her tumor will stop growing immediately," Ravdin said.

Dr. JoAnn Manson, a women's health expert at Harvard-affiliated Brigham and Women's Hospital in Boston who has a new book out on hormones and menopause, thinks the big drop in breast cancer cases could be due to hormones, "especially a reduction in long duration of use."

"It's also possible that a trend toward lower doses of hormones has played a role," she said.

She and other doctors are continuing to study women in the big federal study who had been on hormones and then quit.

Federal statistics for 2004 are expected in April. Information from one large registry, California's, published recently in the Journal of Clinical Oncology, hints that the trend is continuing.

Wyeth Pharmaceuticals, which makes the hormone pills Prempro and Premarin, may not be much affected by the new data, said Deutsche Bank analyst Barbara Ryan. Most women are already aware of the drugs' risks and those that choose to use them do so only for a short time, she said.

"I wouldn't expect a big impact."

On the Net:

San Antonio Breast Cancer meeting:

Hormone study: off(%)

Government's cancer report: s/ReportNation2005release


2006-11-30   Scientists used the abortion drug RU-486 to keep tumors at bay in mice bred with a gene destined to give them breast cancer.

No one is suggesting women use the abortion pill that way. But the provocative experiment helped illustrate how the notorious breast cancer gene BRCA1 does its dirty work, by spurring a hormone called progesterone that RU-486 happens to block.

If researchers could create a safer hormone blocker, it might offer a long-awaited alternative for women with the bad gene. They have few good options today to prevent breast cancer.

"All of us have to be cautious," said cell biologist Eva Lee of the University of California, Irvine, who led the research published in Friday's edition of the journal Science. "But I do think if there is a better anti-progesterone available, hopefully there will be other options in the future for these women."

Cancer specialists not involved with the experiment praised the work, even as they cautioned women not to get their hopes up yet.

"This is an avenue worth pursuing on a research level," said Dr. Claudine Isaacs, an oncologist at Georgetown University Hospital who works closely with carriers of BRCA1 and a related gene.

"This is work in a mouse," she said. "It's clearly too early to start recommending use of this agent."

Dr. Len Lichtenfeld, the American Cancer Society's deputy chief medical officer, said researchers and patients will "take interest in this topic and explore it further."

He called the paper "elegant research," but stressed that "it would not be appropriate in any way, shape or form that women start taking RU-486 for this purpose."

Long-term use of RU-486 could suppress the immune system and cause other side effects.

Some 212,000 women in the United States will be diagnosed with breast cancer this year. Only 5 percent to 10 percent will have a hereditary form. Women who inherit mutations in the BRCA1 gene are at far greater risk of cancer than the average woman. By age 70, more than half of those gene carriers develop either breast or ovarian cancer.

Their options today include:

_Frequent cancer screening, in hopes of catching it early.

_Removing both breasts while they are still healthy.

_Taking the anticancer drug tamoxifen, which helps some women.

_Removing the ovaries before age 50, cutting the risk of both cancers.

These are anxiety-provoking options. Hence the push to determine exactly how BRCA1 triggers tumors, so maybe doctors and women could fight its bad effects more easily.

Particularly puzzling, BRCA1 mutations occur in every cell of the body, raising questions about why the defect would trigger cancer just in reproductive organs.

In their research, Lee and colleagues created mice whose mammary glands only harbor the BRCA1 mutation.

The scientists found that the bad gene caused breast tissue to have too-high levels of progesterone receptors. That means the hormone sticks around longer than it should, in turn sparking excess cell growth. In fact, the mice's breast tissue looked like it should have during pregnancy, when temporarily high progesterone levels cause breast growth as the gland prepares to make milk.

The final evidence came from RU-486, also called mifepristone. It causes human abortions by suppressing progesterone, a hormone crucial to sustaining pregnancy.

Instead of a human pill, Lee implanted some of the cancer-prone mice with an RU-486 pellet designed to slowly emit the drug into their bodies over two months.

By 8 months of age, each of the untreated gene-defective mice had developed tumors. But none of the mice given RU-486 had developed tumors by 12 months, when the study stopped.

Lee cautioned that RU-486 is not a good candidate for such long-term use in people. She said more targeted progesterone blockers already are being developed.


2006-08-21   As lawyers argued over which evidence should be allowed, a judge Monday delayed jury selection in the first trial of 4,500 lawsuits filed nationwide that challenge Prempro, a hormone-replacement therapy that some women say causes breast cancer.

Linda Reeves of Benton sued drug maker Wyeth, claiming she developed breast cancer after taking Prempro for eight years. Helene Rush of Little Rock has argued similar claims in a federal suit against the drug maker. Rush has an Oct. 10 court date.

Prempro is a widely prescribed estrogen-progestin combination used to treat premenopausal symptoms, such as hot flashes.

While plaintiffs say Wyeth was more worried about money than patient safety while developing the drug, the drug company wants jurors to see its request _ made to the Food and Drug Administration in 1983 _ for a study about the effects of combining estrogen and progestin. Reeves' lawyers want the evidence limited, saying jurors could be overwhelmed by such a huge file and miss its key portions.

Lawyers for both sides argued about the evidence before U.S. Magistrate Judge Henry L. Jones Jr. on Monday as Jones filled in temporarily for U.S. District Judge William R. Wilson, who will preside over the trial. Jones pushed back jury selection to Tuesday.

A Women's Health Initiative study found that women who took Prempro had a higher risk of breast cancer, stroke and coronary heart disease.

Wyeth recently reached more than $21 billion in settlements for lawsuits over another drug combination, fen-phen, which was prescribed as a diet drug. Analysts have said they don't think Wyeth's hormone-replacement therapy settlements will be nearly as high as the fen-phen cases.


2006-07-24   Older women who take hormone pills that combine estrogen and testosterone more than double their risk of breast cancer, according to a study of more than 70,000 nurses.

"This type of hormone therapy may help with mood, libido and bone mineral density, but the possible risk of breast cancer may outweigh these benefits," said study co-author Rulla Tamimi of Harvard Medical School.

The findings, published in Monday's Archives of Internal Medicine, add to the evidence that certain types of hormone supplements, such as estrogen-progestin pills, increase women's risk of breast cancer, strokes and heart attacks. Earlier research also found a greater breast cancer risk in women with higher natural levels of testosterone.

The overall risk of breast cancer among the participants in the latest study was small, with 17 cases of the disease among the 500 or so women who took the estrogen-testosterone combination.

Women's natural levels of estrogen and testosterone decline with menopause.

Only about 2 percent of women taking hormones in the study in 2000 used a form that included testosterone. But usage climbed during the 24 years of the study as evidence appeared linking the hormone combination to better bone density, improved mood and greater sexual enjoyment.

Estrogen-testosterone pills are sold under the brand names Estratest and Estratest H.S. by Solvay Pharmaceuticals of Marietta, Ga. Those brand names appear on a Washington-based advocacy group's "Worst Pills" list because of breast cancer risk.

"We strongly urge women not to use this product or similar products from compounding pharmacists," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, which produces the Worst Pills list.

The Food and Drug Administration has asked Solvay for evidence the drug eases hot flashes in menopausal women, as the label claims. The company has requested a hearing on the matter.

The drug was approved 30 years ago, before such evidence was required.

The new study used data from the long-running Nurses' Health Study. The women who took estrogen and testosterone after menopause had a 2 1/2 times higher risk of developing breast cancer than women who never took hormones. Most of the women taking the combination used Estratest.

"The company has not yet had the opportunity to review the details of the study or the content of the article," said Solvay spokesman Gabrielle Braswell.

The researchers took into account other breast cancer risk factors, such as family history, weight and age at menopause and still found an increased risk associated with estrogen-testosterone pills.


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Last update: 2006-07-24

Device detects cancer early

By Craig Joseph
Staff Writer
With the combined efforts of three West Virginia University professors, a device was created that will serve as an early detector for various types of cancer.
Dr. Peter Gannett of the WVU School of Pharmacy, Dr. Daniel Flynn, associate director for basic research at the Mary Babb Randolph Cancer Center, and Dr. David Lederman, WVU physics professor, are awaiting patent protection on a nanodevice that tests a patient's biological fluid for a cancer marker protein called Vascular Endothelial Growth Factor.
The amount of VEGF produced in the body is correlated with whether a person has many types of common cancers, such as breast or lung cancer, Gannett said.
The device is about the size of an eraser tip on a pencil but elongated with a sharp point on one end called a cantilever, Flynn said.
Antibodies (proteins that identify harmful antigens, or toxins), called anti-VEGF, are attached to the tip of the cantilever to capture the antigen, VEGF.
When the cantilever coated with the antibody runs into VEGF, the VEGF sticks and the weight of the cantilever increases, Gannett said.
"So we have a very small cantilever, which sort of resembles a diving board. Flick it, and it will vibrate. Flick it again, it'll vibrate the same weight. This is its natural vibration frequency. Now, add weight to it, flick it, and it will vibrate more slowly. If a sample has VEGF, it will bind to the anti body, increase the weight, and there will be a change in frequency," Gannett said. "It is actually a very simple device except for the size."
Flynn said when the VEGF protein binds to the antibodies, the tip of the cantilever bends by one angstrom or more, which can be measured using a laser.
An angstrom is a unit of length equal to 100-millionth of a centimeter.
"Initial discussions of how to make this were started in December during finals week. The physicists calculated how to make it and the probability that it would work. The prototype device was ready for testing in April," Flynn said.
In addition to Gannett, Flynn, and Lederman, additional research and development for the device has been carried out by graduate student Jarod Kabulski, post-doctoral student Dr. Jianhua Gu, undergraduate student Cristina Pastuch and research assistant Odille Meyers, PhD.
Funding for development of the apparatus has come from the West Virginia Nanotechnology Initiative, which has recently been expanded by a $13.5 million state-wide grant from the National Science Foundation and Governor Joe Manchin.
Additional funding has been given by the Mary Babb Randolph Cancer Center.
The group has also requested $250,000 in funding from the National Institutes of Health. The application is pending, Gannett said.
"A prototype device has an estimate cost of $40,000-$50,000, and this is doing all the work on campus (as inexpensive as it gets). A production device may be simpler than what we are constructing and might cost less to make, but this also depends on how many get made, etc," Gannett said.
Including the equipment required to connect the cantilever device to the real world and measure its vibration frequency, everything could fit into a small suitcase, according to Gannett.
The device will be used on patients for the first time this summer when the group will begin screening stage IV lung cancer patients in attempts to show that VEGF can be detected in their sputum (the biological fluid used in tests), Flynn said.
"The idea is this; most lung cancers are found by accident, say by an x-ray obtained because someone thinks they may have pneumonia," Gannett said.
If instead a tumor is found, it will likely be 1-2 centimeters in size and therefore probably be closer to stage III. At stage III, a patient has about an eight percent chance of living more than five years, Gannett said.
"What we hope is that the cantilever based device can be used in routine screening of all patients as part of an annual check-up and that if a person has cancer, the method will detect it as stage I or II where the odds of living more than five years are nearly 50 percent," Gannett added.
Gannett said the cost of screening to patients will be quite low and in the vicinity of many standard blood tests.



2006-06-24   A multiyear study of elevated breast cancer rates in several Long Island communities found no environmental factors contributing to the spike, the state Health Department announced Friday.

"The results of the investigation found nothing unusual," the agency said in a statement released in Albany.

"We hope that our findings will ease concern among residents in Suffolk County about breast cancer and the local environment," said Health Commissioner Antonia C. Novello. "This investigation represented the largest and most thorough examination of environmental risk factors that may be related to cancer in a particular geographic area."

Despite Novello's comments, a breast cancer advocate immediately derided the findings.

"I totally do not agree," Karen Joy Miller, president and founder of the Huntington Breast Cancer Action Coalition, said in a telephone interview. "We definitely know genetics alone does not cause diseases. To say there are no environmental causes is totally ridiculous."

The study sought to identify unusual environmental factors to explain elevated breast cancer rates _ sometimes as high as 50 percent above average _ between 1993 and 1997 in Coram, Mount Sinai, Port Jefferson Station, Miller Place, Port Jefferson, Sound Beach and East Setauket. The communities are on the north shore of Long Island in eastern Suffolk County.

Researchers met with residents to learn about possible environmental exposures and then obtained data from state and local agencies. The study found the higher than expected breast cancer rate was not significantly different after risk factors about age, race, income and educational level were considered, the health department said.

Also, the study found that the levels of contaminants and other possible environmental exposures in the area were similar to, or lower than, levels in the rest of the state for the majority of those evaluated.

Rep. Timothy Bishop, D-N.Y., said in a statement that further study of the issue is required.

"While no one wants cancer-causing agents to be found in their community, everyone wants to know what is causing such alarmingly high rates of breast cancer," he said. "The finding of `nothing unusual' in these communities does not mean we should give up; it means we should work that much harder to determine the truth."


2006-05-08   Women who take estrogen-only pills for at least 15 years run a markedly higher risk of developing breast cancer, according to a study of nearly 29,000 nurses. But no increased danger was found among those who took the hormone for less than 10 years.

Researchers said the findings should be reassuring for women who want to use estrogen for a short time to relieve menopausal symptoms such as hot flashes and vaginal dryness.

Hormone supplements were once thought to help postmenopausal women postpone age-related ills. But the government's Women's Health Initiative study in 2002 contradicted those beliefs for estrogen-progestin supplements, finding an increased risk of breast cancer, strokes and heart attacks. That led millions of American women to stop taking supplements.

Later, a WHI study of estrogen alone _ an option only for women who have had a hysterectomy _ linked the supplements to strokes and memory problems. But it found that using estrogen alone for seven years does not raise the risk of breast cancer.

The new findings came from the less-rigorous but longer-running Nurses' Health Study, overseen by Harvard-affiliated researchers.

It found no increased risk of breast cancer in women who had taken estrogen for less than 10 years. But for women who had been on estrogen for at least 15 years, the risk of hormonally driven breast cancer (the most common type in the United States) climbed 48 percent. At the 20-year mark, the risk of any type of breast cancer rose 42 percent.

"This says at least for the shorter-term users, you don't need to panic" about breast cancer, said lead author Dr. Wendy Chen, an oncologist and epidemiologist at Brigham and Women's Hospital and the Dana-Farber Cancer Institute in Boston. "But for the longer-term users, you need to think about why am I still taking estrogen for this long of time, and are there are alternatives I could take instead?"

The risk of breast cancer also appeared to rise between 10 and 15 years of use, but the increase was not statistically significant, the researchers said.

The study, published in Monday's Archives of Internal Medicine, involved 28,835 women who were postmenopausal, had had a hysterectomy and reported their estrogen use every two years. Just 3.2 percent of the women, or 934, developed breast cancer during the study.

The researchers said it is unclear how many American women are taking estrogen for 15 or 20 years, especially in light of the WHI findings and doctors' recommendation since then that women who want to use the pills take them for the shortest possible duration.

Dr. Carolyn D. Runowicz, president of the American Cancer Society, said a few women in her practice have chosen to remain on estrogen for a long time because they feel the improvement in their quality of life outweighs the risks.

Runowicz called the study reassuring for short-term estrogen use but also said it underscores the need for patients to regularly "justify every medication" they take with their doctors.

"Is it estrogen forever? That's what we thought in the 1970s," said Runowicz, director of the Cancer Center at the University of Connecticut Health Center, "but we've completely reversed our thinking on that."

Estrogen-alone supplements are given only to women who have had their uteruses removed, because the hormone can spur uterine cancer. Other women get estrogen plus progestin, to counteract the risk of uterine cancer.

The Women's Health Initiative was a clinical trial in which women were randomly assigned estrogen pills or placebos. Scientists consider that approach the gold standard. The new study relied on nurses who reported on their own health every two years.

Runowicz said nurses could differ somewhat from women in the general population _ perhaps they are healthier, for instance _ but she said she had no reason to doubt the validity of the data, especially because its conclusions regarding short-term estrogen use are backed up the WHI findings.

Wyeth, which produces the estrogen pill Premarin, considers the Nurse's Health Study a well-respected study and the most recent research a "fairly reasonable trial," said Dr. James Pickar, assistant vice president for clinical research and development.

Pickar said he sees the results as good news for women because they back up the WHI findings that found no increased breast cancer risk for short-term estrogen users.

"I think it's very important for women to talk to their physician and review on a regular basis whether they need to continue therapy," Pickar said. "Each patient has an individual risk profile that only they and their physician can evaluate."

2006-03-27   Weightlifting appears to improve breast cancer survivors' outlook on life, suggests one of the first studies to scientifically measure the effects of such exercise.

About 80 percent of women who took up twice-a-week weight-training saw improved scores on a quality-of-life survey, researchers said, in a study to be published in an upcoming issue of the journal Cancer.

In contrast, 51 percent of participants in a control group did.

The physical and psychological benefits of exercise are well-documented. But this study is the first to apply scientific methodology to looking at how weight-training helps women who have had breast cancer.

"This may seem like common sense to most folks, but there's really been no literature or science where researchers tried to quantify and verify the effect," said Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society.

Researchers recruited 86 women from the Minneapolis-St. Paul area in late 2001 and early 2002. Each of the women had completed successful treatment of breast cancer within the previous three years.

Half the women were assigned to an exercise group. For three months they met twice a week with personal fitness trainers to develop a weightlifting regimen. They were then encouraged to follow it for another three months.

The second group had no such regimen.

Researchers asked women in both groups a series of questions about physical well-being, marital happiness, sexual activity and other aspects of life.

Women in the exercise group had a modest improvement over members of the non-exercising group, Lichtenfeld noted.

However, the women in the exercise group said they felt they had more strength, speed and self-confidence as a result of the workouts. It appears the weightlifting helped them regain a feeling of control of their bodies, researchers said.

The more women improved on bench press, the better they said they felt overall. That may be because breast cancer treatment can reduce the ability to lift and carry things, said Kathryn Schmitz, a University of Pennsylvania researcher who co-authored the study.

The study also tried to observe weight-training's effect on depression. The researchers didn't measure any significant effect, but they said that might be because such a small number of women were deemed to suffer from depression at the outset of the study.

Last update: 2006-03-27

Vitamin D May Cut Breast Cancer Risk

2006-04-04   Women who get lots of vitamin D are less likely to develop breast cancer, suggests a pair of studies that add to the already strong evidence that the "sunshine vitamin" helps prevent many types of cancer.

High levels of vitamin D translated to a 50 percent lower risk of breast cancer, one study found. Even modestly higher levels resulted in 10 percent less risk, which would translate to 20,000 fewer cases a year if it were true of all American women.

A second study, by Canadian researchers, found that women who spent time outdoors or got a lot of vitamin D from their diets or supplements _ especially as teens _ were 25 percent to 45 percent less likely to develop breast cancer than women with less of the nutrient.

"Exposure to vitamin D at the time breasts are developing, particularly around adolescence, might be important," said lead researcher Julia Knight of Mount Sinai Hospital in Toronto.

Both studies were presented Tuesday at a meeting of the American Association for Cancer Research.

The body makes vitamin D from sunlight, but sun exposure is controversial because of the risk of skin cancer. Many health experts see little harm in 15 minutes several times a week.

Vitamin D is found in salmon, tuna and other oily fish, and is routinely added to milk, but diet accounts for very little of the nutrient that actually makes it into the bloodstream.

Supplements contain the nutrient, but most contain an old form, D-2, that is less potent than the harder-to-find D-3. Multivitamins typically contain little D-2 and include vitamin A, which offsets many of D's benefits.

So getting enough D safely and effectively is tough, but important, as the new studies show.

One, led by Cedric Garland of the University of California in San Diego, involved more than 120,000 women participating in two studies at Harvard University and Saint George's Hospital Medical School in London. Blood samples were obtained from 701 with breast cancer and a similar group of 724 healthy women.

Those with the highest blood levels of vitamin D had a 50 percent reduced risk of breast cancer, but very few women are at this level. It would require taking 1,000 international units of vitamin D a day, and most Americans get only about 320, Garland said.

Government advisers can't agree on an RDA, or recommended daily allowance, for vitamin D but say "adequate intake" is 200 international units a day up to age 50, 400 IUs for ages 50 to 70, and 600 IUs for people over 70.

Garland and many other scientists have been advocating 1,000 IUs a day, but warn people not to overdo it because too much can cause a dangerous buildup of calcium in the body.

Still, "it's becoming clearer now that we can take higher doses than people used to think," said Knight, who led the Canadian study.

It involved about 1,000 women with breast cancer and a comparison group of healthy women randomly selected through phone calls.

Those without breast cancer were less likely to cover up whenever they were outside and more likely to get dietary sources of vitamin D or to have had cod liver oil, which is rich in the nutrient, as children.

Diet is one of the few factors women can modify to affect their risk of developing breast cancer, so the vitamin D evidence is important, said Dr. William Nelson, a cancer specialist at Johns Hopkins School of Public Health who had no role in the studies.

"Consumers are looking for guidance" on what foods can help protect against cancer, he said.


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Last update: 2006-04-04
2006-04-13   Britain's health service broke the law when it refused to pay for a woman's breast cancer treatment with a potentially life saving drug, an appeals court ruled Wednesday.

Herceptin is not licensed for treating early stage breast cancer in England and Wales and is only authorized for use on patients in advanced stages of cancer.

The case began when a local branch of the National Health Service denied Ann Marie Rogers, 54, the drug, saying her circumstances were not so exceptional she should be offered the drug in contravention of licensing rules.

Rogers challenged the decision, but a lower court found the Swindon Primary Care Trust acted appropriately.

But Wednesday, Britain's Court of Appeal ruled the Swindon Primary Care Trust acted unlawfully when it refused her request for the drug.

"I couldn't have asked for a better verdict, I did this for all women battling this dreadful disease," Rogers said, as she wept and hugged supporters.

Yogi Amin, one of Rogers' lawyers, said the judgment means hundreds of women in Britain may now be eligible for treatment with the drug, funded by their health authority.

Rogers' lawyers told the court that she considered the decision to deny her Herceptin to be a virtual "death sentence."

Some patients in Britain have paid for the drug themselves when denied the treatment by the health service, believing it offers them better prospects than conventional treatment.

Herceptin is thought to cut in half the chances of a recurrence of the HER-2 early form of breast cancer, Rogers' lawyers said.

Jan Stubbings, chief executive of the Swindon trust, said it had provided Herceptin for Rogers as her case went through the courts.

The Swindon trust had operated a policy of offering treatment with Herceptin in cases where a doctor considered there to be exceptional circumstances, she said.

Rogers' attorneys argued that it was wrong for the trust to discriminate between cases in such a way.

In his ruling, judge Sir Anthony Clarke _ one of three judges who decided on the case _ said the policy "in this particular case was irrational and therefore unlawful."

Lawyers for the health authority had argued that Britain's National Institute for Clinical Excellence _ which regulates use of prescription drugs in Britain _ has not yet determined if Herceptin was safe or effective.

Last update: 2006-04-13

Sisters of Breast Cancer Victims Studied

2006-04-15   When Gina Gordick heard her younger sister had breast cancer, she wanted to do something more than just make her soup and run errands. Gordick, 55, of Fayette, says watching someone you love fight breast cancer is a "painful, miserable, awful" experience.

"My sister's diagnosis sent the whole family into a tizzy," Gordick said. "It's a helpless feeling. You want to do something, but there isn't anything to do."

Gordick finally found a way to help through the Sister Study, a national effort centered on women whose sisters have had breast cancer. Conducted by the National Institute of Environmental Health Sciences, investigators hope to determine how environment and genes in families affect the chances of getting breast cancer.

Sisters of someone who has breast cancer have twice the risk of developing breast cancer than women whose sisters don't have the cancer, not only because they share genetic factors but also because they likely have been exposed to similar potential carcinogens, said Dr. Dale Sandler, chief of the epidemiology branch of NIEH.

"When they've grown up together, they ate the same, maybe lived next to the same factory, perhaps have the same tendency to gain weight," Sandler said. "Sisters will be more identical in those sorts of things, even if as adults they have very different lives."

Investigators hope to find 50,000 women aged 35 to 74 who will agree to fill out four questionnaires, complete two one-hour phone interviews and donate blood, urine, toenail and household dust samples. After that, participants are asked to update investigators at least once a year for the next 10 years on any health-related issues.

That information will be compared between women who do and do not get breast cancer, in hopes of finding common factors.

Since the study began in October 2004, 26,000 women from across the country have signed up. Investigators are making a strong effort to include women from all economic and racial backgrounds so the eventual results apply to everyone, Sandler said.

"We need variation to pick up the subtle signals," she said. "No one has found the one big environmental factor for breast cancer. There hasn't been a link made like smoking to lung cancer."

Despite the variations, Sandler said the volunteers generally are motivated by the same things.

"The fear of getting breast cancer may be a motivation. But we're finding that people really do this more out of a love for their sisters," Sandler said. "And they say it may not help them avoid cancer, but maybe we'll learn something so their daughters don't get breast cancer."

Those were the motivations for Susan Meilink, 48, of St. Charles County, a nurse whose sister was diagnosed with breast cancer 10 years ago at the age of 32. Her sister, also a nurse, has been through several other health crises but currently is doing well and is pregnant.

"She's the most phenomenal person I know," Meilink said. "She was only 32, we had no family history of breast cancer. We thought 'Where did this come from?'"

Neither Meilink or Gordick can think of any particular environmental factor in their pasts that may have caused their sisters to get cancer and both believe researchers will eventually find a range of risk factors that women will need to avoid.

While Meilink's sister was the first in the immediate family to get breast cancer, the disease has haunted Gordick's family. Since her sister was diagnosed, her mother, aunt and sister-in-law have been diagnosed.

All are currently healthy, but the cancers made Gordick and other family members quit their jobs to move within 20 minutes of each other, and to become deeply involved in educating women about preventing breast cancer.

Gordick's sister, Patricia Broeckling, of Columbia, said she participated in several clinical trials while fighting breast cancer, mostly to help her three daughters and other young women arm themselves against the disease.

And she and her sister say they push women who are eligible to participate in the Sister Study.

"This is the easiest thing a woman can do to help," Gordick said. "The answer to cancer is going to be in the research. That's where they are going to find out what factors contribute to a majority of this and, hopefully, researchers will be able someday to prevent it from happening."


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