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Breast cancer research: What you need to know

Dayton Daily News (OH) - 10/18/2014

Oct. 17--Significant strides are being made in the fight against a common enemy that will attack one out of eight women in the United States.

After increasing for years, the occurrence of breast cancer in women declined in the early 2000s, largely the result of breakthroughs in research, such as the discovery of the her2/neu gene which was found to play an important role in the development and progression of certain types of aggressive breast cancer. Today, the drug, Herceptin, is used to treat thousands of women with these types of breast cancer.

"Thanks in part to the progress we're making together, death rates from breast cancer have dropped by 34 percent since the early 1990s," says William Phelps, program director for the American Cancer Society. "This translates to 203,000 lives saved that would have otherwise been lost to breast cancer."

The importance of trials

Cancer clinical trials play an essential role in improving treatment options.

"Everyone dealing with a diagnosis of cancer should be encouraged to speak with their doctor to see if clinical trial participation is right for them," said Dr. Charles Bane, a medical oncologist who is president of Dayton Physicians Network and a doctor with Premier Health. It is through clinical trial, he said, that new treatment options are evaluated, tested and approved.

"Many clinical trials opportunities are available in Dayton and there is no need to travel to distant facilities to receive treatment," he added. "Each trial does have specific requirements and some people may not be eligible for participation due to the status of their cancer or the presence of other complicating medical conditions."

There are currently more than 20 clinical trials for patients with breast cancer living in the Miami Valley, according to Bane. The trials are available to all the medical oncologists in the area.

"Patients with early stage breast cancer often receive some treatment to prevent recurrence of their cancer," he said. "There are many proven treatment combinations designed for this purpose and many current clinical trials are investigating ways to make these treatments better."

This type of trial, he explains, may involve the modification of an existing treatment to make the treatment easier to tolerate or the addition of a new medication, which is given along with the current proven therapy, to make it more effective.

"Other clinical trials are designed for people with more advanced stages of cancer who may have already received some cancer treatment," Bane said. "These trials often involve testing a new form of therapy which we hope may be successful after other available standard treatments have already been tried."

Other research options

Suzanne Coleman, director of Innovation, Research & Grants at Kettering Health Network, says her network provides numerous opportunities for breast cancer patients to participate in research studies.

"These range from active treatment trials with new therapies to studies that examine the issues patients face with regard to quality of life, and emotional and spiritual challenges when met with a diagnosis of breast cancer," she explains.

Coleman said there are now 16 open studies for treatment of breast cancer through KHN's association with Dayton Clinical Oncology Program, the collaborative effort among hospitals in the region to have leading edge research available locally from the National Cancer Institute's vast number of cancer studies.

"These studies offer a variety of treatment regimens including pharmaceutical therapies (IV or oral), radiation treatment, or a combination of both," Coleman said, adding that patients may be participants in studies for a few weeks, months or even years, depending on the protocol and the extent of their disease.

"In addition to these treatment trials, we have had a high participation rate in the studies we have initiated over the past two years to determine how best we can provide the services that support a holistic approach to navigating the breast cancer journey," she added. "While treatment trials address the more immediate concerns of patients, these quality-of-life studies help us to better understand the range of issues breast cancer patients face and how we can positively support their needs."

Tina Osborne of Cedarville took part in a breast cancer clinical trial in 2007 after she was diagnosed with invasive ductal carcinoma. The trial was designed to determine if one of the drugs that had traditionally been given could be eliminated.

"If you can help somebody down the road to take the best medicine for them or the one with the least side effects, that's what you want to do," said Osborne, who has four granddaughters. "I want to spare them from breast cancer if I can."

An example of a recent trial

One of the more recent grant-funded trials Kettering has been asked to conduct is a study comparing two different FDA-approved nuclear medicine imaging agents used to better define the sentinel lymph node when undergoing breast cancer surgery. A sentinel lymph node is the first lymph node to which the cancer cells are most likely to spread from a primary tumor.

For this study, on the day of surgery, patients receive an injection of the study drug, followed by nuclear medicine imaging to help identify the sentinel lymph node(s). Coleman said the important information is used by the surgeon during breast surgery to target the most likely pathway for possible spread of the breast cancer to the surrounding lymph nodes and is critically important in developing the most appropriate treatment plan for that patient after surgery.

Research for Triple Negative breast cancer

Triple negative -- a classification of breast cancer -- represents 15-20 percent of the more than 211,000 women diagnosed with breast cancer annually in the United States. These cancers are often more aggressive, occur in younger women and have limited treatment options. This kind of cancer typically affects women -- not men -- in the 18-40 age range with a higher propensity in African-American women. Typical treatment is chemotherapy through IV.

"This cancer has a lack of the estrogen receptor --the protein on the outside of the cell that causes it to grow and divide and the place we can target a medication," said Dr. Erin Macrae, a breast medical oncologist with The Ohio State University Comprehensive Cancer Center -- Arthur G. James Cancer Hospital. "There are no targeted therapies for this type of aggressive cancer so if we can find a new treatment that specifically inhibits the way it grows, it would be a major advancement in triple negative breast cancer treatment."

Macrae is leading a phase 2 clinical trial that opened in 2013 and tests a new two-drug combination. Participants take two pills a day: an experimental agent is given in combination with the drug, trametinib, to simultaneously target two distinct pathways thought to interact to cause cell growth and enable cells to become cancerous.

"By blocking two cancer-promoting signaling pathways simultaneously, you have the potential to stop a cancer's ability to become resistant to treatment," Macrae said. "This is novel because these medicines are given by mouth and can be taken at home. The results are unknown, however, we are hopeful that the clinical trial will show that this drug combination may decrease tumor growth in these patients."

Relieving side effects

Dr. Rebecca Glaser, a breast cancer surgeon for more than 16 years, is now devoting her time to making life easier and improving symptoms for breast cancer survivors. She presented her most recent findings last month at a Breast Cancer Symposium of the American Society of Clinical Oncology in San Francisco.

She reported that testosterone, combined with an estrogen blocker, anastrozole, was safely able to relieve menopausal symptoms in breast cancer survivors.

"Most people are under the impression that estrogen is a female hormone and testosterone is the male hormone but that's not the case," Glaser said. "In fact, women have much higher levels of testosterone than they have estrogen. Women with breast cancer who are experiencing troubling symptoms are typically told they can't be treated with hormones because estrogen may stimulate the breast cancer and cause it to grow.

Testosterone, she explained, inhibits the growth of the breast cancer cells but it can convert to estrogen. The new twist is that Glaser has added an estrogen blocker to the testosterone in a slow release, pellet implant, and has shown that it is effective and safe.

"Every three months in a procedure that only takes a minute or so, two small pellets are placed under the skin, releasing both testosterone and anastrozole together 24 hours a day," she said, adding that the new treatment is being used on breast cancer survivors who are experiencing menopausal symptoms -- sleeplessness, hot flashes, fatigue, depression, sexual problems, urinary symptoms, mood changes and more.

Glenda Christian, a 22-year breast cancer survivor, is a patient of Glaser's.

"This treatment has really helped me live a more fulfilled and better quality of life," said the Centerville woman, who has been receiving the pellet treatment for the past six years. "It has alleviated a lot of my symptoms -- fatigue, stress -- it helps me function better."

What she discovered by studying the symptoms of 72 breast cancer survivors was that the new treatment has been effective in treating those symptoms and improved the quality of life for those women who received it. Glaser, an assistant clinical professor at Wright State University'sBoonshoft School of Medicine, worked on the study with Dr. Constantine Dimitrakakis, a professor at Athens University School of Medicine in Greece who collaborates with the National Institute of Health, in Bethesda, Md.

"We've performed over 1,000 testosterone plus anastrozole pellet insertions in breast cancer survivors since 2006, there have been no adverse drug events in any breast cancer survivor that received this treatment and no cancer recurrences in up to 8 years of therapy," she said.

There is now a national trial -- Alliance: A221102-1 -- sponsored by the Mayo Clinic and the National Cancer Institute looking at the ability of the combination implants to relieve joint pain caused by oral aromatase inhibitors, which are used to treat breast cancer. The trial is available locally through the Dayton Clinical Oncology Program.

Glaser believes that controlling joint pain, along with hot flashes and other symptoms, is important because up to 40 percent of women stop taking their cancer medications because of these side effects.

The battle isn't over

The American Cancer Society's Phelps said we still need to be full speed ahead when it comes to breast cancer research.

"Today, we're seeing research efforts focused on immunotherapy, new targeted drugs, and a wealth of new opportunities which could lead to the prevention or inhibition of breast cancer metastases," he said. "We are also seeing a sustained emphasis on discovering the causes of breast cancer. While we want to be able to cure the disease, we'd prefer it never happen in the first place."

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