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Why Clinical Trials?

It is an interesting time in breast cancer research. As the molecular biology reveals new potential targets (biomarkers) for therapy, we are starting to test them-not in rats, but in real women.

One example is triple negative breast cancer, which has gotten a bad rap lately. The name triple negative is enough to scare anyone. Yet, this type of tumor really isn't so bad. In fact, it is the type of tumor that responds best to chemotherapy.

Even so, there is little doubt that finding a targeted therapy for this type of tumor-like we have for HER2+ and ER+ tumors- would be a huge advance. That's why researchers are very excited about a new class of drugs called PARP 2 (poly(ADP-ribose) polymerase ) inhibitors.

The first studies on PARP2 inhibitors-like those on all new treatments-were done in rats. When these studies had promising results, the researchers were ready to move on to the next step: seeing if this treatment would also be beneficial in women. The first step in this process is studying women with metastatic disease. Researchers study these women first because they are the women who have tried everything else and who are most in need of a new treatment.

These initial small trials allow us to see if the drug is safe and effective. If it is, the next step is to conduct a randomized clinical trial that would compare a PARP2 inhibitor to another drug. If the women on the PARP2 inhibitor do better, then we know it has promise. But, you say, why not just try the drug in everyone from the beginning? The problem is that drugs that work great in rats don't always work well in women.

Not that long ago, we thought that very high doses of chemotherapy with stem cell rescue would be better than regular dose chemotherapy. Because everyone thought this was true, it was hard to get enough women to participate in a clinical trial that would compare the two treatment options. Finally, though, enough women enrolled, and when the trial results were published we learned that standard dose chemotherapy is just as effective as high dose chemotherapy! Our guesses are not always right!

My goal in explaining this is to highlight for all of you the value of clinical trials. These trials provide us with the evidence that can tell us whether our hunches and hypotheses are correct, and form the foundation of good breast cancer care. (You can learn more about clinical trials here.)

Those of you who are contemplating a change in treatment or even starting a new treatment might well want to investigate the clinical trials that are available to you at www.breastcancertrials.org. This site has an easy-to-use matching service that can help women find trials they may qualify for. It also provides easy-to-read trial summaries, a secure message service for contacting participating research sites, and a trial alert service that will notify you when newly posted trials match your health history.

If not for a group of courageous women who agreed to participate in a groundbreaking study that randomly assigned women to have either a mastectomy or a lumpectomy followed by radiation, we would not know that breast conservation is just as viable an option as mastectomy. Those women are heroines, and you can be too!

You've signed up for the Army of Women and you've made a pact to help eradicate breast cancer. Our trials are focused on prevention and detection. But women with breast cancer should also consider trials that are studying breast cancer treatments.

Let us know if you find a trial that is right for you! Sharing information about your experience may encourage others to take part, too!

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