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