Breast Cancer

Importance of Clinical Trials in Breast Cancer

Clinical trials have led to advances in treatment that have revolutionized the way women with breast cancer are treated compared with treatments 20 or 30 years ago. For example, many women with breast cancer enjoy longer lives with a better quality of life because hormone (endocrine) therapy, trastuzumab (Herceptin), and lumpectomy were found to be effective in clinical trials. A variety of treatment options continues to be evaluated in clinical trials, offering the promise of additional therapies for breast cancer. Deciding whether to volunteer for a clinical trial is a major decision, and women should understand the potential benefits and risks of a trial before agreeing to enroll.

Potential Benefits and Risks

The primary benefit of a clinical trial is access to the highest quality of cancer treatment, with the possibility of receiving a new treatment before it is widely available. Women who have participated in a clinical trial have noted such advantages as having access to the best available care, receiving newer/better treatment, receiving increased medical attention, playing an active role in their own health care, and making a valuable contribution to cancer research.

Clinical trials are also associated with potential risks. A trial carries the risk of the unknown: Will there be side effects to a new treatment? Will a new treatment or new combination of treatments really improve the survival rate? Because of these unknowns, a requirement of clinical trial research is that individuals are fully informed about all the potential risks and benefits before they agree to participate. It is important to note that clinical trials have several built-in safeguards to ensure the safety of participants. Women who volunteer to participate in a clinical trial will be monitored closely throughout the trial.

What to Expect in a Clinical Trial for Breast Cancer Treatment

In most breast cancer treatment trials, women are randomly assigned to one of two or more groups. In one group, women will receive the currently available best standard treatment and in the other group or groups, women will receive the experimental drug (s) or treatment(s) being studied, usually in addition to the best standard treatment. Most studies are blinded, which means that the doctors and the study participants do not know what group they are in. Blinding helps to prevent the results from being influenced by the expectations of the researchers or the participants.

The research team will give each participant specific instructions pertaining to the trial, will evaluate each participant’s health at the beginning of the trial and monitor it carefully during the trial, and will stay in touch with each participant after the trial ends. Participants get the most benefit from the trial if they carefully follow the instructions and remain in contact with the research staff. Joining — and staying — in a clinical trial is completely voluntary. If you volunteer for a clinical trial, you may change your mind and not participate. You also have the right to leave the clinical trial at any time for any reason, and you could then receive the currently available standard treatment.

Clinical trials are a valuable source of progress in the treatment of breast cancer, but they may not be right for every woman. You should learn as much as you can about clinical trials by talking to your doctor, and reviewing educational resources. Ask your doctor to explain all the potential benefits and risks of a clinical trial in language that you can understand. Some specific questions can help you decide whether a clinical trial is right for you.

Questions You Should Ask to Help You Decide Whether to Volunteer
for a Clinical Trial

• Why is this trial being done? Are there other trials for which I might be eligible?
• Why do the doctors who designed the trial believe that the treatment being studied may be better than the one being used now? Why might it not be better?
• What is likely to happen in my case if I decide to participate/not to participate?
• What are my other options (standard treatments, other studies)? What are their advantages and disadvantages?
• What were the results of any previous studies of this treatment?
• What are the possible side effects or risks of the new treatment? What are the possible benefits?
• How will the doctor know if the treatment is working?
• Can I choose to continue to get this treatment, even after the study ends?
• Are there other sources of information about the study (for example, the Internet)?
• How long will I be in the trial?
• What kinds of tests and treatments are involved?
• How could the trial affect my daily life?
• Will I have to travel somewhere to receive treatment? Will I be compensated for travel expenses?
• How often will I have to come to the hospital or clinic?
• Will I have to be hospitalized? If so, how often and for how long?
• What type of long-term follow-up care is part of the study?
• Will I continue to be under the care of my doctor, or will I be seeing a different one (or both)?
• Are there others participating in the study I could speak to?
• Will I have to pay for any of the treatments or tests?
• What costs will my health insurance cover?

Additional Sources of Information

• American Cancer Society: www.cancer.org
  Clinical Trials: What You Need to Know
• American Society of Clinical Oncology (ASCO) patient site: www.cancer.net
  Clinical Trials
• Coalition of Cancer Cooperative Groups: www.cancertrialshelp.org
  Learn about Cancer Clinical Trials
  Patient Testimonials
• National Cancer Institute: www.cancer.gov
  If You Have Cancer...What You Should Know About Clinical Trials
  Taking Part in Cancer Treatment Research Studies
  Taking Part in Clinical Trials: What Cancer Patients Need to Know
  Understanding Cancer Clinical Trials (17-minute DVD)
  Patient Testimonials
  Should I Take Part in a Clinical Trial?