Clinical Trials for Breast Cancer

Overview
Depending on several factors, you may be eligible to participate in clinical trials studying new treatments for breast cancer. Clinical trials are the only way that new treatments for breast cancer can be tested. Eligibility factors may include what type and stage of cancer you have, your age, and which treatments you have already received. Good times to consider entering a clinical trial are just after diagnosis, before treatment begins, or if you have had a recurrence, before you begin treatment for the recurrence.

The goal of Phase 1 clinical trials is to test how a new drug or treatment should be administered, what dosage and frequency is safe and effective, as well as establish side effects. Phase 2 trials test whether the treatment is effective against breast cancer specifically. Phase 3 trials test the effectiveness of the new treatment against current standard treatments. Phase 4 trials may be designed to test long-term results or answer new questions that have arisen about the treatment.

Everyone who participates in a clinical trial receives treatment. Although some people worry that they will receive a placebo, or sugar pill, instead of treatment, the fact is that placebos are not used in clinical trials for cancer. Half of the participants in a study will receive the new, experimental treatment, while the other half will receive the standard treatment currently given for the type of cancer they have. Your treatment will be assigned randomly, and you will not be told which treatment you are receiving.

Clinical trials may test new drugs, new dosages or new combinations of existing drugs; new treatments such as genetic testing to target tumors more precisely; new formats of treatments such as radiation; or new combinations of treatments such as surgery and chemotherapy. Trials may also pair standard treatments with complementary practices such as yoga or acupuncture. Quality-of-life or supportive care trials may be testing new palliative drugs to better control nausea or fatigue during standard cancer treatment. There are also research projects consisting of surveys or interviews with women who have breast cancer to better understand their needs, preferences or decision-making processes.

What all clinical trials have in common is that every participant receives at least the current highest standard of treatment, and that the knowledge gained from the trial may benefit other women with breast cancer.

Clinical trials are often funded by organizations such as the National Cancer Institute, the American College of Radiology Imaging Network, the Department of Defense and the Department of Veterans Affairs. Susan G. Komen lists several websites where you can find clinical trials at the bottom of this page [http://ww5.komen.org/BreastCancer/ClinicalTrial...].

What does it involve?
Before you enroll in a clinical study, read the informed consent form very closely. Ask your doctor or the doctor in charge of the study to explain any portions you have trouble understanding. Pay close attention to descriptions of the potential risks and benefits associated with participation. Work with your medical team to decide whether a clinical trial is right for you.

Don’t be afraid to ask questions; you have the right to know what will take place during the trial and what it could mean for you. Consider taking a family member or friend with you to meetings regarding a clinical trial to help take notes and ask questions. Find out what tests and treatments are involved in each step of the clinical trial. Ask about how the treatment being tested differs from the current standard treatments. Find out which costs are covered, and whether you or your insurance company will be expected to pay for the rest. You can ask whether you will still have access to the treatment after the study ends, in case the new treatment proves effective in your case. You may ask to speak to someone who is already participating in the clinical trial about their experiences. You may also want to know how your private medical information will be protected during and after the trial.

You can withdraw from a clinical trial at any time.

Intended Outcomes
The goal of participating in a clinical trial is to receive the highest possible standard of treatment for breast cancer, whether that is an existing standard or a new, experimental treatment.

Results
Depending on the clinical trial you are considering applying for, there may or may not already be results available from previous clinical trials. Ask the clinical research coordinator or a nurse or doctor participating in the trial for information about results.

A 2006 study by the Coalition of Cancer Cooperative Groups showed that 92 percent of people who survived cancer and had participated in clinical trials said that they were satisfied with their experience, and 91 percent said they would recommend that a friend participate in a clinical trial.

Constraints
Although the new treatment may be more effective than the standard treatment against some breast cancer, it may not be more effective in your specific case.

The new treatment may cause unforeseen side effects. Although the doctors leading the clinical trial will educate you about known risks, it’s impossible to know what might happen with a novel treatment.

Some insurance companies may not cover all costs associated with being in clinical trials. However, any remaining costs will usually be covered by the company or sponsor of the clinical trial. Be sure to ask about costs before enrolling. Find out which medical expenses will be paid by the trial, whether the sponsor will cover any care resulting from injury or damage you may receive as part of the trial, and whether long-term aftercare is included.

Some trials may be located far from your home and necessitate travel.