The process of demonstrating whether a novel treatment method is better than the previous ones requires breast cancer patients to volunteer to take part in the testing of new drugs and procedures. These tests are called clinical trials.
Clinical trials need to be done in an unbiased way, if their results are to be deemed reliable. This would call for women to be randomly assigned into one or more treatment groups. In the end, the outcomes of the treatment of the various groups of the trial are compared against each other. Randomization of research subjects in clinical trials is responsible for the many recent advances in cancer treatment. Data drawn from several trials have shown that less surgery and radiation therapy are as effective as more invasive mastectomies (breast resection). Some also show that providing chemotherapy to women with non-metastasized breast cancer prevents the appearance of systemic spread and that the use of tamoxifen (a selective estrogen receptor modulator) increases the cure rate in women with hormone positive breast cancer. Through the randomized method, the physician and investigator bias has been eliminated, which is a major problem in clinical research trials comparing a novel therapy to standard treatment.
Women who have been willing to participate in clinical research trials have made a significant contribution to medical advancement. Each of these trials tests a new hypothesis and the results then become a knowledge base for succeeding clinical trials. In order to show significant differences in therapeutic modalities, several thousand women are needed as research subjects for each trial. These volunteers are well aware that they may be getting established or experimental treatment and will not be told which. These women bravely participated with this magnitude of uncertainty, not knowing if one treatment is more or less effective than the other, but agreed to help answer the question of which the more optimal therapy was. The difference in each treatment regimen in trials today involves the sequencing of various treatments or the addition of a new drug.
There are also studies called pilot trials. These are usually done in a center that is implementing clinical research that is not sponsored by the National Cancer Institute and is not randomized. Usually, these studies are sponsored by drug companies, or conducted at a university. There are safeguards in place in pilot studies to protect the research subjects as much as possible. Oftentimes, these protocols are only for women with advanced cancer who may be willing to place themselves at risk because of limited treatment options available to them at that that late stage of breast cancer.
Most human clinical research trials are divided into three phases depending upon the question, which it is attempting to answer. Phase I testing is designed to determine if a new treatment has acceptable tolerability to cancer patients and at what dosage significant side effects start to occur. Once a drug or a treatment method has been proven safe, Phase II clinical trials quantifies the objective response rate, that is, if treatment results in a measurable reduction in cancer. In women with breast cancer, both Phase I and II testing is performed on those with metastatic spread. Phase III testing involves a comparison of standard treatment to a promising one that has already gone through Phase I and II testing. Most women enrolled in this phase of clinical trials are those with a newly diagnosed breast cancer.
If you have breast cancer and you would wish to participate in such a trial, ask your oncologist if you are eligible to enroll in one. Your ability to participate may depend on the health care delivery system you are in, so you should talk to your Health Insurance Company or HMO representative. Generally, the coming years should prove very promising in the field of breast cancer research, primarily because there are phenomenal scientific resources being dedicated to the cause.
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