Low Participation in Breast Cancer Prevention Trial

A major breast cancer clinical trial to determine if prophylactic (preventive) chemotherapy can reduce breast cancer risk is desperately lacking sufficient participants.

The trial, although based in the U.K., mirrors the difficulty U.S. researchers have in enrolling sufficient numbers of women to participate in crucial research studies.

Writing in the British medical journal The Lancet, Dr. Gareth Evans of St. Mary's Hospital in Manchester and colleagues reported on their ongoing study of women with a greater than 40 percent lifetime risk of developing breast cancer due to a family history of the disease, carrying the BRCA1 or BRCA2 gene mutations, or other significant risk factors.

Each of the 4,475 women enrolled so far has been given the choice of four treatment options: entry into one of two chemoprevention trials; preventive mastectomy; or ongoing breast screening with MRI. Only 10 percent of the women have chosen a chemoprevention trial or mastectomy; 60 percent have chosen MRI surveillance.

In the case of women determined to be at the highest risk of developing breast cancer (60 - 80 percent), more than 61 percent opted for mastectomy-reducing even further the pool of participants in the chemoprevention studies.

The Importance of Clinical Trials

Most successful treatments used today began as clinical trials, which involve a three-step process to evaluate the safety and effectiveness of a new treatment. Those patients who participate in such trials are the first to potentially benefit from any improved therapies.

Clinical trials take place in many hospitals across the country. Each study is carefully designed to reveal specific information about how safe and effective a new drug or treatment will be.

Clinical trials typically involve three stages or phases:

• Phase I - This is the first time that a new drug or treatment is tested in people. It usually involves only a small number of patients, but gives an early indication of the drug's safety and potential effectiveness. Side effects, while unpredictable, are carefully monitored.
• Phase II - A phase II trial continues to test the safety of a drug, and attempts to measure how well it will actually work. A larger number of patients are enrolled in phase II trials so physicians can better assess the anti-cancer impact of the treatment. Side effects continue to be monitored.
• Phase III - By this time, the new drug or treatment has shown early promise in treating a particular disease. The treatment will now be compared to a current standard. A participant will be randomly assigned to receive either the new treatment or a standard treatment (the "control group"). Phase III trials enroll large numbers of people and are conducted at medical centers nationwide.

All clinical trial participants receive the best care possible, and their reactions to all treatments are closely monitored. If the treatment does not seem to be helping, your doctor will remove you from the study. In addition, you may choose to leave the trial at any time. If you leave a research study for any reason, standard care and treatment are still provided. There is no penalty for leaving a clinical trial.

Unfortunately, participation rates in clinical trials by eligible breast cancer patients-especially older and minority patients-are extremely low. This has major implications for advances in breast cancer treatment.

Nearly all of the treatment options that are available to you today have come from previous breast cancer clinical trials. These include modern mammographic screening techniques; the use of adjuvant chemotherapy and hormonal therapies; and the combination of radiation therapy with lumpectomy for the effective treatment of breast cancer.

If you believe you are eligible for a clinical trial, or would simply like to know more about them, ask your doctor.

SOURCE:
The Lancet, September 15, 2001; 358:853-889-890

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