Arrow Catalog
Arrow Patient Centers
Arrow Breast Cancer
Center Home
Breast Cancer Center
Advanced Breast Cancer

Keeping Current with New and Experimental Treatments

The following article is excerpted from Chapter 6 of Advanced Breast Cancer: A Guide to Living with Metastatic Disease, 2nd Edition, by Musa Mayer, copyright 1998, published by O'Reilly & Associates, Inc. For book orders/information, call (800) 998-9938. Permission is granted to print and distribute this excerpt for noncommercial use as long as the above source is included. The information in this article is meant to educate and should not be used as an alternative for professional medical care.

In the ongoing struggle for control of the disease, new treatments are constantly being introduced into clinical trials. In the last several years, breast cancer research has been burgeoning, spurred in part by the influx of government research funding that advocates from the National Breast Cancer Coalition and other organizations have fought so hard to win since 1992.

Basic cancer research begun a quarter century ago has accelerated understanding of the mechanism of cancers on a cellular level. Many innovative treatment methods are just beginning to flow from these new developments, as well as further refinements of conventional drugs. Now that more energy is being expended in genetic and molecular biology research, there is every reason to believe that within the next few years, sophisticated new methods that are targeted (only to cancer cells) rather than systemic (affecting normal body cells)--and thus less toxic--will be found to further prolong life for those with metastatic breast cancer. Some of the more exciting new developments are touched upon in the section, "What's new?" later in the chapter.

Because this field is rapidly evolving, it makes good sense, when you discover your breast cancer has metastasized, or when the disease progresses further, to devote some real time and effort to researching the state of what is currently known about treatment for your specific situation. As we've pointed out elsewhere, having a spouse, friend or family member do the research for you can work just as well. There may well be new clinical trials for which you are eligible. There may be innovative treatments unpublished as yet in the literature, or not yet widely known, that your doctor may not even be aware of.

Those who do participate in clinical trials perform an invaluable service, advancing and refining knowledge in the field of oncology that will eventually help other patients. The National Alliance of Breast Cancer Organizations (NABCO), in collaboration with the National Cancer Institute, estimates the rate of breast cancer patients receiving treatment in clinical trials at about 5 percent. This very low level of participation is thought to have slowed the rate of progress in treating the disease successfully. Why more women do not take part has to do with limitations on research funding, as well as with public and physician attitudes and barriers erected by the health care system. NABCO speculates that certain misunderstandings perpetuate the low participation rate:

By law, all clinical trials must include safeguards to protect patients. Trials must be reviewed by both the sponsoring institutions and the medical community for patient safety and scientific merit. Trials sponsored by the National Cancer Institute (NCI) are required to meet extensive ethical standards of the National Institutes of Health (NIH).

Participants in a clinical trial must give their informed consent based on extensive, understandable information and explanation, and may withdraw from a trial at any time. Patient information is kept strictly confidential.

Most health plans do not cover experimental treatments or the associated doctor and hospital costs. However, TRICARE/CHAMPUS, the Department of Defense health program, has agreed to reimburse members who participate in NCI clinical trials. The NCI along with the American Society of Clinical Oncology (ASCO) and advocates are working with government and private health providers to insure coverage of patient participation in high quality peer-reviewed clinical trials.1

In a clinical trial, drugs are first tested for dosage and efficacy, and then the best available treatment is compared with one or more experimental treatments that have already been tested in the laboratory and on patients to determine levels of toxicity. Phase III clinical trials are often done at multiple treatment sites so that enough patients can be enrolled to make the findings valid. There are usually strict requirements for acceptance, and extra testing and record keeping is done for evaluating progress. The treatment protocols, both standard and experimental, are designed by experts in the field, based on the latest findings. Patients are closely monitored for symptoms and side effects, so medical care is generally excellent. If possible, the study is "blind," so that raised expectations of the experimental treatment don't confound the findings. So that the results can be scientifically valid, patients are typically randomly assigned by a computer to the different study groups, or "arms." This is the best way to rule out differences in outcome that may be due to other factors. Sometimes, in smaller studies, patients are matched or "case controlled" instead, so that very similar case histories can be compared.

Ask your oncologist to suggest clinical trials that may be relevant to your case, the National Cancer Institute suggests, since he or she is likely to have access to trial information. But be prepared to take a lot of the initiative yourself in investigating and researching possibilities. While most doctors are happy to do so, some may hesitate about losing their patients to a clinical trial team. Others may be biased toward research at their own institutions. Also, oncologists treating patients with many different kinds of cancer may not have the time or inclination to research all available trials, and may be aware only of the higher-profile trials.

Since clinical trials often take years to enroll enough patients and demonstrate results, sometimes ethical problems result when it begins to look as if an experimental drug will be more or less beneficial, or sometimes even harmful, than the standard treatment with which it is being compared. If the protocol being tested involves currently available substances, women will often elect not to join a clinical trial, in which they run a fifty-fifty chance (sometimes less, if there is more than one experimental arm of the study) of being randomized not to receive the drug. Instead, if the drug is already approved for other uses, they may try to find a doctor who will treat them independently. This has happened in recent years with the proliferation of off-trial use of high-dose chemotherapy with stem cell transplant, discussed later in this chapter.

Clinical trials advance medical knowledge, and they also benefit patients. Women who participate in clinical trials do so in part because they know that the knowledge gained will help others, ultimately, and also because this is one way of getting state-of-the-art treatment, observation and care. Most importantly, they choose to participate because they hope to gain access to experimental treatments at least as good as the best standard care for their stage of disease. In her book The Activist Cancer Patient, Beverly Zakarian advises a commonsense approach. Forget the popular myth of trial participants as "guinea pigs," she says:

There is only one important question: Are YOUR best interests served by participating in a clinical trial? Because a clinical trial is, practically speaking, just another treatment option, you should evaluate the information and make treatment choices the same way you would if it were not a trial.2
As stated earlier, the NCI CancerNet Service on the Internet is a good place to look for experimental treatments currently in clinical trials, as is the Centerwatch Clinical Trials Listing Service. Both web sites explain the nature of clinical trials.3


  1. Joining a Clinical Trial, from the National Alliance of Breast Cancer Organizations (NABCO) website.
  2. Zakarian, Beverly, The Activist Cancer Patient: How to Take Charge of Your Treatment (New York: John Wiley and Sons, 1996), p. 120.
  3. NCI CancerNet Clinical Trials information and Centerwatch Clinical Trials Listing Service.

Patient Centers Home |  O'Reilly Home  |  Write for Us
How to Order  |  Contact Customer Service

© 2001 O'Reilly & Associates, Inc.