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Clinical research
studies offer us the best hope for the proper evaluation
of drugs and medical techniques. This site offers you the
opportunity to obtain credible information on clinical trial
research and to assess your chances of getting breast cancer.
Many drugs, agents, and remedies have been suggested to
prevent cancer. This Web site supports and advocates only
those that have undergone the rigorous testing of a U.S.
federally approved clinical trial that are sponsored by
the National Cancer Institute (NCI).
Two such clinical trials include the Breast Cancer Prevention
Trial (BCPT) and the Study of Tamoxifen and Raloxifene (STAR).
The BCPT included more than 13,000 women at increased risk
for breast cancer and demonstrated the value of the drug
tamoxifen in reducing the incidence of the disease in this
population. The second prevention trial, STAR, is one of
the largest breast cancer prevention studies ever untaken.
This study recruited more than 19,000 volunteers and closed
to enrollment in October 2004. Preliminary results of this
trial are now available at www.nsabp.pitt.edu.
This Web site is a product of the
National Surgical Adjuvant Breast and Bowel Project
(NSABP).
What is a clinical trial?
Clinical trials are research studies in
which people help doctors find ways to improve health and
cancer care. Each study tries to answer scientific questions
and to find better ways to prevent, diagnose, or treat cancer.
Why are there clinical trials?
A clinical trial is one of the final stages
of a long and careful cancer research process. Studies are
done with people who volunteer to find out whether promising
approaches to cancer prevention, diagnosis, and treatment
are safe and effective.
What are the different types of clinical trials?
• Treatment Trials test new treatments (like a new cancer
drug, new approaches to surgery or radiation therapy, new
combinations of treatments, or new methods such as gene
therapy).
• Prevention Trials test new approaches, such as medicines,
vitamins, minerals, or other supplements that doctors believe
may lower the risk of a certain type of cancer. These trials
look for the best way to prevent cancer in people who have
never had cancer or to prevent cancer from coming back or
a new cancer occuring in people who have already had cancer.
• Screening Trials test the best way to find cancer, especially
in its early stages.
• Quality of Life Trials (also called Supportive Care trials)
explore ways to improve comfort and quality of life for
cancer patients.
What are the phases of clinical
trials?
Most clinical research that involves the testing of a new
drug progresses in an orderly series of steps, called phases.
This allows researchers to ask and answer questions in a
way that results in reliable information about the drug
and protects the patients. Clinical trials are usually classified
into one of three phases:
• Phase I trials: These first studies in people evaluate
how a new drug should be given (by mouth, injected into
the blood, or injected into the muscle), how often, and
what dose is safe. A Phase I trial usually enrolls only
a small number of patients, sometimes as few as a dozen.
• Phase II trials: A phase II trial continues to test the
safety of the drug, and begins to evaluate how well the
new drug works. Phase II studies usually focus on a particular
type of cancer.
• Phase III trials: These studies test a new drug, a new
combination of drugs, or a new surgical procedure in comparison
to the current standard for treatment. A participant will
usually be assigned to the standard treatment group or the
new treatment group at random (called randomization). Phase
III trials often enroll large numbers of people and may
be conducted at many doctors' offices, clinics, and cancer
centers nationwide.
For more information, please see the National cancer Institute's
brochure, Taking Part in Clinical Trials: Cancer Prevention
Studies.
This Web site is a product
of the
National Surgical Adjuvant Breast and Bowel Project
(NSABP).
http://www.breastcancerprevention.org/
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