Clinical trials are a vital source of research work conducted in breast cancer and other cancer treatments. The participation of the breast cancer patient is necessary to the success of clinical trials. These clinical trials study the effects of new treatments and monitor side affects so that better medication and therapies can be administered to breast cancer patients across the board. Only about 5 percent of breast cancer patients are currently enrolled in clinical trials. There is not enough information given out about it and generally speaking, clinical trials are misunderstood. Many cancer patients do not even know how to join one.

Breast cancer clinical trials

Clinical trials are necessary to test new treatments on breast cancer patients and to determine if the treatments are effective. Clinical will determine the side affects if any. The clinical trial could also test new medical procedures, for their efficacy in detecting cancer and determining the shape, size, location, and progression of the cancer as well. When a study is done using petri dishes, examining cells, or using animal experimentation, these studies are not clinical studies they are what is called pre clinical studies. A clinical trial is only merited after the initial pre clinical trial suggests that this new treatment would benefit humans. It is then, that testing must be done on people to further ascertain if the results of pre clinical trials are substantiated. Pre clinical trials are an important first step in breast cancer research but they cannot replace the necessity of testing out how effective these new therapies would be on the actual people who are affected by breast cancer.

Clinical trials set out to answer two questions

Does this new therapy, drug, or procedure work in humans and will it be proven to be a better treatment than what is out there now? Will it work in people who are currently benefiting from the current therapies or breast cancer treatments?

The second question that must be answered is to determine the side affects of the drug or procedure and if this medication or breast cancer therapy is so good that it will outweigh the side affects?

Clinical trials show researchers which therapies and procedures will or will not work and why. Unfortunately, researchers cannot predict what the results of the clinical trial will be otherwise there would be no reason to conduct these clinical trials in the first place.

Since this is the case, many breast cancers patients are afraid of participating in a clinical trial. It is important to note that even though there may be some negative affects resulting from the participation in a clinical trial, there is also the fact that thousands of patients have benefited from new and improved therapies and medications because of the clinical trial volunteers.

Deciding on whether or not participating in a breast cancer clinical trial is right for you is a personal choice but it is also one that should be talked over with your doctor. Your doctor will go over the benefits and risks unique to your personal situation.

Many of the current hormonal and targeted therapies such as the use of Herceptin, Aromatase inhibitors, Tamoxifen and even radiation were first tested in clinical trials. There are actually about 1,000 pre clinical tests on new drugs done, before one of them will be deemed successful enough to make it to the clinical trial stage of testing. Furthermore a new drug will be tested at the pre clinical trial stage for about six years before it graduates to the clinical stage if it can make it that far.

Clinical trials can take place at hospitals and various cancer centers across the nation. Researchers wanting to conduct a clinical trial will have to fill out a detailed plan of how the trial will be conducted, what dosages of medication will be given, how this treatment is expected to be better than current therapies and so on. Then a review board will study the plan to determine if the clinical study is justified.

Clinical studies are usually divided into one to four treatment plans.

Randomized studies select breast cancer patients at random

Double blind studies are studies conducted where neither the researcher nor participant will know which treatment will be given to them. This type of study is designed to eliminate any kind of bias such as a preconceived idea of how you would respond to a given treatment. This kind of bias could affect the outcome of the study.

Any person wishing to participate in a clinical trial will be asked for their written consent. Furthermore a participant can quit the trial at any time.

The stages of the drug testing include:

Phase 1 testing in humans, using a small sample of about 15 people. Here the researchers are looking at the best way to administer the drug (pills versus injections) and what is the highest dosage that can be given.

Phase 2 testing will involve about 25 to 100 participants. The goal is to find out if the medication works and whether it will enhance the breast cancer patient’s quality of life.

Phase 3 testing can involve thousands of people and the main focus of this phase is to determine if the new therapy is better than the current therapies in use.

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