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Clinical Trials: The "Gold Standard" of Breast Cancer Treatment
NSABP Foundation

Clinical Trials: The "Gold Standard" of Breast Cancer Treatment

By Dr. Jame Abraham, Director, Breast Oncology Program, Taussig Cancer Institute, Cleveland Clinic

The chair in front of my desk is where some of my hardest conversations take place. Yet it is also where some of the most inspiring and hopeful moments of my career happen. All my patients at one time or another have sat in “the chair.” We talk about their diagnosis, their treatment options, test results and always, we talk about the patient’s option to participate in clinical trials.

Clinical trials change the game for the treatment of breast cancer. Indeed, clinical trials change the game for all cancers. They are the gold standard of treatment and save countless lives.

In the 1980’s, 5-year survival rates for breast cancer were 75% percent. Now, thanks to advances in treatment made through clinical trials, that number is 90%. As doctors and researchers, we’re not satisfied with that—we’re nowhere near finished. We aim for 100%. The needle keeps moving forward, and survival rates increase, thanks for the thousands of sisters, daughters and mothers who sat in their doctor’s chair and said, “I will participate in a clinical trial.”

Saying “I will” means that, at minimum, the patient gets the current standard of care for her type of breast cancer. In addition, a tightly controlled and regulated trial of a new drug or treatment protocol is administered, in hopes that it makes a positive difference in outcome and can then become approved as a new treatment. During a clinical trial, the patient is monitored by a comprehensive care team. There are more touchpoints and checkups for a patient in a trial than one not in a trial, which is an added benefit as any health changes (positive or negative) are closely followed.

I can’t underestimate the importance of trials. Starting with my very first patient in 2001, a clinical trial made a difference. She was a 34-year- old with Stage II-B cancer, four lymph nodes were involved. She was a high-risk patient. At the time, NSABP was running a trial to see if the drug Herceptin, already approved for use in Stage IV patients, could be helpful for Stage II and III patients as well. This was a “randomized” trial, which means that 50% of participants would get Herceptin and the other half would not receive it. My patient enrolled. She did not get Herceptin, but did receive the current standard of care. After the trial, results came in and they were so exciting: the use of Herceptin increased survival rates by 50%! I immediately called my patient and told her the good news, that she was now eligible (along with thousands of other women) to receive Herceptin to prevent recurrence. Because of my patient and women like her, the lives of countless patients were extended. Herceptin is now part of the standard of care for women with this particular cancer—and now the bar is raised higher. We continually search for ways to improve survival rates even more. Game-changers like this are made possible through trials. They are the only way.

I have so much respect and appreciation for the women who make the choice to participate. They have so much on their plate—their diagnosis, their treatment, their jobs, their children, their families. Yet they are moved to participate. They think about the possibilities for the future, and the hope that a new treatment will provide for yes, perhaps themselves, but also for the women that come after them.

In the U.S. alone, we still lose about 40,000 mothers, daughters and sisters a year to breast cancer. It’s too many. Across the world, more than half a million women will die annually from breast cancer. If more of the nearly 250,000 women a year who are diagnosed with breast cancer participated in one of the 4,000 available trials, we could save so many more.

When I have a woman sitting across from me in that chair, and I review their treatment options, it often comes as a surprise to find out that their current treatment, whatever it is, came about because of a trial. Because a woman just like her sat in a chair, pondered a future of possibility, and said, “I will.”

For more information about clinical trials, visit clinicaltrials.gov. Even more important, talk to your doctor.

Jame Abraham, MD, FACP, is the Director of the Breast Oncology Program at Taussig Cancer Institute at Cleveland Clinic and co-director of the Cleveland Clinic Comprehensive Breast Cancer Program. Dr. Abraham is also a professor of medicine at Cleveland Clinic Lerner College of Medicine. Dr. Abraham’s primary focus and passion is taking care of patients with breast cancer. He has been selected by Cleveland Magazine and Newsweek as the top oncologist locally and nationally, respectively. You can follow Dr. Abraham on Twitter: @jamecancerdoc.

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