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Clinical Trials
WHAT ARE CLINICAL TRIALS?
A clinical trial is one of the final stages of a long and careful cancer research process and the main way to make progress in treating cancer. A clinical trial matches cancer patients, doctors, and new therapies aimed at preventing disease, improving chances of cure, increasing life expectancy, and/or improving quality of life.
Doctors perform clinical trials because they believe the drugs or techniques they are testing could be more effective or safer than the standard treatments. They have to show this belief scientifically and beyond a measurable doubt so that the FDA (Food and Drug Administration) will consider approving the drugs/techniques for other people with the same cancers.Â
WHY ARE THEY IMPORTANT?
Clinical trials are the only accepted scientific method to determine if a new treatment works better than the current standard of care. Despite the promise offered by clinical trials, less than 5% of adult cancer patients enroll in them. This lack of participation slows progress in the development of new, more effective therapies. By contrast, more than 60% of children with cancer are enrolled in clinical trials. Approximately three-quarters of children with cancer survive their disease long-term, compared with half of adults. The increased survival rate for children can be directly linked to their higher rate of participation in cancer clinical trials.
Nationally, there are close to 5,000 cancer clinical trials underway. Clinical trials are sponsored by the National Cancer Institute (NCI), drug companies, medical institutions, and other research-based organizations. They are carried out in environments that ensure patient safety and care: doctors’ offices, cancer centers, other medical centers, community hospitals and clinics, and veterans’ and military hospitals. All of today’s recognized cancer treatments were proven by cancer clinical trials before they became generally available.
EXAMPLES OF ADVANCES IN BREAST CANCER TREATMENT FROM CLINICAL TRIALS
- Raloxifene (Evista) as treatment for prevention of invasive breast cancer in certain groups of high-risk women.
- Tamoxifen as treatment for reducing the incidence of breast cancer.
- Herceptin as treatment for reducing the recurrence of breast cancer for HER2-positive breast cancer patients.
- Neoadjuvant therapy for locally advanced breast cancer patients. These trials proved that neoadjuvant therapy (that is therapy administered before surgical resection) could safely be administered to patients with locally advanced breast cancer allowing the surgeons to proceed with breast preservation while achieving comparable local control rates and survival rates as the more extensive surgery.
- Efficacy of Lapatinib in women with Her2-positive breast cancer that had failed Herceptin based chemotherapy. This has given new hope to women with advanced Her2-positive breast cancer and has led to many new trials looking at the combination of Lapatinib and Herceptin in this population of patients. Many of these trials are showing remarkably higher response rates for the combination therapy than previously seen for the single agents, many with very impressive pathological complete response rates when the combination is used in the neoadjuvant fashion.
- New drug development for women with triple negative breast cancer using novel agents such as the PARP inhibitors for women with triple negative breast cancer.
Ask your doctor if there is a clinical trial you should consider as you learn about your treatment options.
A good place to begin looking for information is at www.cancer.gov, the primary website for the National Cancer Institute (NCI), and www.cancer.net, the website for the American Society of Clinical Oncology (ASCO).