Leon Hwang, MD

Clinical trials are research studies designed to improve treatment for those diagnosed with cancer. Some trials investigate new cancer drugs and treatments while others compare standard treatments with new treatments. Before a new treatment is offered to a participant in a clinical trial, it is carefully studied in the laboratory. All our current standard cancer therapies were once experimental research therapies evaluated in clinical trials. Only after clinical trials show one treatment to be superior can that therapy become a new standard treatment. All advances in cancer treatment must be evaluated through clinical trials.

People who participate do so for different reasons. Participation in clinical trials may offer the possibility of new therapies not available to all patients. Some of the research therapies prove to be major advances in treatment, some do not. Research trial protocols are created by the national experts in those particular diseases, so the quality of treatments chosen is high. Some people participate in hopes of helping future patients or future generations.

Our research team will assist you in determining if you are eligible for a clinical trial. Simply ask us if a clinical trial is available for your type and stage of cancer. Most clinical trials enroll individuals who are in reasonably good health other than a cancer diagnosis. A number of “eligibility criteria” exist to make sure the trial is safe for the participants. We will also determine final medical eligibility in accordance with the criteria of the trial protocol. You may qualify for our trials if you are an adult with a confirmed cancer diagnosis, are an active participant in your treatment plan, and are interested in learning more about potential novel treatments.

At Kaiser Permanente, we have a commitment to offer state-of-the-art treatment to our members with a diagnosis of cancer. At any one time, there are more than 30 cancer trials available for Kaiser Permanente patients within the KP Oncology Clinical Trials program (KPOCT). More than 300 Kaiser Permanente patients enter oncology clinical trials in Northern California every year. Interested members may be able to participate in promising new cancer treatments even before they are approved by the Food and Drug Administration (FDA) and available commercially to the general medical community. These new treatments are offered though the KPOCT program. This program consists of a team of oncologists, nurses, and research specialists who review and select clinical trials for our program. The majority (95 percent) of the clinical trials offered through Kaiser Permanente are multi-center trials conducted at university medical school cancer centers and other cancer treatment research centers across the U.S. Kaiser Permanente participates in national trials through national cooperative research groups such as NSABP (National Surgical Adjuvant Breast and Bowel Project), SWOG (Southwest Oncology Group), CTSU (Clinical Trials Support Unit), as well as selected pharmaceutical industry sponsored studies. Most people are not aware that Kaiser Permanente in Northern California is a major participant in these organizations and their trials. You can also find all available clinical trials at www.clinicaltrials.gov.

There are 4 phases to the clinical trials process: Phase 1 - Experimental treatments are evaluated to determine the best dosage and evaluate for side effects. Many treatments do not progress past phase 1. Phase 2 - Once dosage and side effects are known, trials are conducted to get an idea if the new treatment has a beneficial effect (a response rate) in a certain disease. More toxicity information is learned. Phase 3 - The new therapy is compared to the current standard therapy in a randomized trial to see which therapy is better. Phase 4 - After a therapy or drug is approved and felt to be a standard therapy, many more cases are reviewed in order to detect uncommon side effects or outcomes. We participate in mostly Phase 3 trials, and in some Phase 2 trials.

The doctors who conduct a clinical trial follow a carefully designed treatment plan called a protocol. This spells out what will be done and why. Our clinical research study protocols are designed by national experts to safeguard the medical health of patients and answer important research questions. Often a standard therapy is compared to a promising new therapy which we hope will be an improvement. The trial is the test to see which treatment is better. Medications that are not yet approved by the Food and Drug Administration (FDA) for another condition but that show promise for your condition are only given within the context of a clinical trial.

Whether you are in a research study or not, you face many medical appointments, examinations, procedures, and therapies. We will explain in detail the risks and benefits and answer all the questions you might have concerning specific clinical trials. If you join a research study, data on your case will be carefully recorded. Patients in clinical trials are followed very closely according to the research protocol. This close follow-up is often more structured than observation outside of a clinical trial.

If you are thinking about taking part in a clinical trial, some important questions to consider include: What is the purpose of this study? What kinds of tests and treatments are there? How does this compare to standard therapy? What are my alternative choices for treatment? What side effects can I expect? How does this compare to standard therapies? How long will the study last?

Informed consent, and understanding the research program you are agreeing to, is an important part of a clinical trial. It is a requirement in all research. You will be given an oral explanation as well as written information in order to understand what is involved in the trial. This includes possible risks and benefits. You will also be given the opportunity to consider taking part in the trial, ask all necessary questions, and freely choose whether you wish to participate. Those who decline to participate or later withdraw will continue to receive the best medical care. If you enter a trial you will be advised of new developments as the trial goes on. After signing the consent form, you are still free to leave the trial at any time. However, we encourage you to take your participation in the trial seriously and to agree to participate only after thoughtful consideration.

Not every patient chooses to participate in a clinical trial. Participation is completely voluntary. We will discuss clinical trials as an option to consider instead of standard therapy. You will never be enrolled in a trial without your knowledge and informed consent. Your treatment will not be affected in any way if you decline to participate in a clinical trial.

To find out about all of our available trials, call the Kaiser Permanente Oncology Clinical Trials Program at (707) 651-2786. The National Cancer Institute web page for clinical trials across the U.S. can be found at www.cancer.gov/clinicaltrials. The Cancer Information Service is a nationwide telephone service that answers questions from patients and their families. Spanish-speaking staff members are available. Call 1-800-4CANCER.

Genes are the instructions that guide the growth and development of your body. Your genes are located in each cell of your body. You are born with two copies of each gene – one inherited from your mother and the other inherited from your father.

There are genes that are important for controlling growth of cells in the breasts and ovaries. These genes are called breast cancer susceptibility genes. The two most common breast cancer susceptibility genes are called BRCA1 and BRCA2. There are other breast cancer susceptibility genes, but BRCA1 and BRCA2 are responsible for most inherited susceptibility to breast and ovarian cancer.

Everyone has two copies of BRCA1 and BRCA2 – one copy from each parent. In some families, there is a mutation (genetic change) in one of the BRCA genes. The BRCA mutation can come from either side of the family. A woman with a BRCA mutation has a much higher chance, or susceptibility, for developing breast and ovarian cancer. Even men in these families have a higher chance of developing breast cancer. While a BRCA mutation results in a higher chance of developing breast and ovarian cancer, it does not cause cancer. Not everyone who inherits a BRCA mutation will develop breast or ovarian cancer.

Not necessarily. Most breast and ovarian cancers that happen in families are not due to a BRCA mutation, but are caused by other factors. Only about 5 to 10 percent of breast and ovarian cancers are related to inherited mutations in BRCA genes.

BRCA mutations have been identified in families worldwide. There are certain risk factors that help identify who might carry a BRCA mutation. You have a higher chance of carrying a BRCA mutation if you answer “yes” to one or more of the following statements: 

• I have had invasive breast cancer and ovarian cancer.
• I have had invasive breast cancer in both breasts.
• I had invasive breast cancer before age 40.
• I had invasive breast cancer before age 50 or ovarian cancer and my ancestry is Central or Eastern European (Ashkenazi) Jewish.
• I have had invasive breast cancer (especially before 50) or ovarian cancer and one or more of my close relatives has also had invasive breast cancer and/or ovarian cancer. 
• I am a male who has had invasive breast cancer.
• I have a strong family history of invasive breast cancer (especially before age 50) and/or ovarian cancer.

Testing is most useful for individuals who are at high risk. If your personal or family history of cancer does not show any special risk factors, then you do not need to have genetic counseling or consider testing. However, you should still follow the routine screening recommendations for breast cancer.

Talk with your provider about your concerns. After reviewing your family history and your personal health history, your provider may refer you to a genetic counselor. Genetic counseling is the first step in determining if a BRCA mutation is in your family, and estimating the chance that you may have inherited this mutation. During counseling, the genetic counselor will review your medical records, your health history, and your family history of cancer.

A blood test is available to look for mutations in the BRCA1 and BRCA2 genes, but the test is not for everyone. Testing is most useful when your personal and family history of cancer shows a pattern of an inherited susceptibility to cancer. Your genetics consultation will help determine whether or not testing would be the best option for you.

Deciding about testing for a cancer susceptibility gene is very personal. It can have complex, and sometimes unexpected, emotional effects. One important part of genetic counseling is helping you explore what testing means for you and your family. Your genetic counselor will discuss the pros and cons of genetic testing, including emotional aspects, impact on the family, confidentiality of results, and cancer screening options.

A positive BRCA test means a mutation has been identified in one of the BRCA genes. A woman with a BRCA mutation has a lifetime chance of developing breast cancer that may be as high as 85 percent, with a chance of at least 15 percent that she will never develop breast cancer. It also means that she has a high risk of ovarian cancer. Men with a BRCA mutation may be at higher risk for breast and other cancers.

Some people who get a negative test result are relieved. Others who test positive use the results to help plan their medical care and personal decisions. Screening more often and starting at a younger age may help find breast cancer early when it can be successfully treated. You may also want to consider certain surgeries that could help to reduce your risk of developing cancer.

A negative test may give some women a false sense of security, so they may not come in for routine mammograms and breast exams. Testing positive can create stress, especially if no clear plan of action is in place to deal with the results.

After reviewing your medical history and obtaining a detailed family history, we offer testing to our members (female and male) who are found to be at risk for carrying a mutation in a cancer susceptibility gene. We also offer online education, group classes, and individual genetic counseling. Our genetics Web site www.genetics.kaiser.org has additional information.