Clinical Trials

It is by conducting research of this kind that science will determine treatments that work best and rule out ones that don't work as effectively. For some people this will result in lives saved. For others, it will mean a longer life in weeks, months, years, decades.

If you have been diagnosed with breast cancer, you might be interested in learning about clinical trials that might be appropriate for you. Not all clinical trials will apply to you, so not everyone is eligible to participate in one.

Thousands of women have received bone marrow or stem cell transplants for locally advanced or metastatic breast cancer. There has been a lot of controversy lately about whether this procedure is better than standard chemotherapy in prolonging survival for breast cancer. Many feel that the existing data indicates that it is not better than standard chemotherapy. Others feel that there are shortcomings in the existing studies and that more research is needed to answer this question. The fact is that if the thousands of women who have received transplants over the years were enrolled in clinical trials designed to answer this question, we would have the answer by now.

Clinical trials are crucial to answering these questions and we need answers now.

What is a clinical trial?
A clinical trials is a research study in which patients participate by receiving a treatment which is being investigated as a new way to prevent, diagnose or treat a disease.

A randomized controlled clinical trial is a research study in which a particular treatment (which can be a drug, a kind of surgery, a type of radiation, for example) is tested against the standard accepted treatment for the disease. This kind of research study is considered the gold standard for scientific research.

Many of the treatments that we now consider standard therapy for breast cancer have come about through the results of this kind of clinical trial. The efficacy of mastectomy versus lumpectomy versus lumpectomy plus radiation is one example. Women with breast cancer were randomized to one of the three arms in this study to answer this question.

The efficacies of chemotherapeutic agents like CA, CMF, tamoxifen and herceptin have all been subjected to this kind of research in patient populations.

More information on clinical trials
1. New therapies are tested on people only after laboratory and animal studies show promising results.

2. A placebo is an inactive pill, liquid or powder that has no treatment value. Placebos are not given in cancer treatment clinical trials, however, they may be used in prevention trials.

3. What is informed consent? Anyone entering a clinical trial in the U.S. is required to sign a form indicating that they understand what will happen to them during the research study. This form starts the informed consent process. Even if a patient signs an informed consent, she may withdraw from a clinical trial at any time.

4. What protections are there for patients participating in clinical trials? To protect patients participating in clinical trials, every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits.

5. What is the FDA? The Food and Drug Administration is an agency within the Dept. of Health and Human Services. The FDA does not do research. Part of their mission is to promote public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner.

There are different kinds of clinical trials
There are clinical trials for women who have been diagnosed with breast cancer; these are "treatment trials."

There are clinical trials for women who haven't been diagnosed with breast cancer but may be at high risk; these are "prevention trials."

There are clinical trials to determine the best way to screen for cancer; these are "screening trials."

There are trials to determine ways to improve comfort and quality of life for cancer patients. These are "quality of life" trials.

There are different phases of clinical trial research
Phase 1 trials involve a small number of patients (15-30) and test the best way to administer a drug (orally, intravenously, injection etc.), how often and the safest dose with the best effect. About 70% of drugs tested in Phase 1 trials are successfully tested and go on to Phase 2 trials.

Phase 2 trials continue to test the safety of the drug and evaluate how well it works.

Phase 3 trials test a new drug against the standard therapy accepted for treatment of the disease. These trials assign patients at random to one of the two groups, one for standard therapy or one for the treatment under research. These trials enroll large groups of people and may be conducted nationwide.

Donate Now