Two Major Trials Set to Launch
Two major new breast cancer clinical trials will soon be launched to see whether combining different breast cancer treatments will actually increase their effectiveness. According to The Breast Cancer International Research Group, these studies will evaluate different combinations of four different treatments for aggressive breast cancer associated with the HER2-neu gene: Adriamycin, Cytoxan, Taxotere and Herceptin.
In total, about 15,000 patients will be screened at more than 650 institutions. Out of this pool, researchers plan to enroll about 6,000 patients.
These trials come on the heels of a major initiative launched last year by the National Cancer Institute-the STAR trial (Study of Tamoxifen and Raloxifene)-which hopes to determine which of these two major breast cancer drugs works better to actually prevent breast cancer. As many as 400 medical institutions nationwide are participating in the study, which plans to eventually enroll more than 22,000 postmenopausal women at high risk for the disease.
Clinical trials are research studies conducted with people. Many trials try to find better ways to prevent or treat diseases, while others test new ways to detect or diagnose a disease.
Participants take part in clinical trials for many reasons. Usually, they hope for a cure and for a way to contribute to a research effort that may help others. Also, participants in a clinical trial are among the first to receive the new treatments before they are widely available. The care they receive is always the best available.
There are three main phases of clinical trials:
If you enroll in a clinical trial and your treatment does not seem to be helping, the medical doctor can decide to take you off the trial. Also, you can personally decide to leave the trial at any time. If you leave the trial for any reason, your continued care will not be jeopardized.
Unfortunately, despite the extraordinary promise of these and other clinical trials, the participation by cancer patients in general-and breast cancer patients in particular-is dismal.
In a presentation to delegates at the recent annual meeting of the American Society for Clinical Oncology, Dr. Robert Comis of the MCP Hahnemann University Clinical Trials Research Center in Philadelphia, said that 84 percent of cancer patients are simply unaware of clinical trials or not sure that they would be an option for them. The findings were based on a survey of 6,000 cancer patients by Harris Interactive.
Only 4 percent of the cancer patients interviewed by Harris Interactive said they had participated in clinical trials. About 58 percent of the respondents said they would never participate in a clinical trial; fear of getting insurance coverage for the trial costs was mentioned as a concern by a majority of these respondents. They also cited worries that they would not get the best treatment or that they would get a placebo instead of a real drug. More than 20 percent said they would feel like a "guinea pig."
Yet, in the same survey 97 percent of the patients who had participated in clinical trials said they received excellent or good quality care and that they were treated with dignity. And the vast majority said they would recommend participating in clinical trials to others. Eighty-six percent of the patients also said they were able to secure insurance coverage for their participation.
A recent panel discussion sponsored by the Susan G. Komen Breast Cancer Foundation reported that only 3 percent of eligible breast cancer patients participate in clinical trials in the United States, while enrollment rates are as high as 70 percent for breast cancer trials in Scandinavia and 50 percent for U.S. pediatric cancer trials.
Reasons cited for this low enrollment rate were: failure by the physician to mention that trials existed; time requirements on physicians; and basic misperceptions about the nature of trials. Furthermore, both patients and physicians may be uncomfortable with randomization, said the panelists, even though cancer patients are randomized either to the best standard therapy or to promising new therapies.
A recent study published in the New England Journal of Medicine looked at how many patients 65 years of age and older were involved in 164 Southwest Oncology Group (SWOG) cancer treatment trials between 1993 and 1996. Dr. Laura Hutchins of the University of Arkansas for Medical Sciences in Little Rock and colleagues analyzed treatment trials for 15 types of cancer and found that older patients are "substantially underrepresented."
Patients who were 65 years of age or older accounted for only 25 percent of patients in SWOG trials, but they comprised 63 percent of the cancer patients in the U.S. population, they wrote.
They added that the under-enrollment of older patients was "particularly striking" for breast cancer trials. In those studies, only 9 percent of participants were 65 years of age or older, versus 49 percent of patients in the general population with breast cancer.
And a recent trial that investigated the preventive use of tamoxifen for breast cancer had so few African-American participants that there was insufficient data to show whether tamoxifen could benefit these women. African-American women are known to have estrogen-receptor-negative tumors more often than white women and to develop the disease at a younger age.
Experts are unanimous about the dire need to dramatically increase enrollments in cancer clinical trials. As Dr. Nancy Davidson of the Johns Hopkins Oncology Center in Baltimore noted during the Komen Foundation symposium, "Everything we can tell patients today is based on the results of clinical trials that have been done in the past."
Nearly all of the advances in current breast cancer clinical treatment now available to women have come from major randomized clinical trials. These include the use of mammography for screening, the use of adjuvant chemotherapy and hormonal therapy, and the use of lumpectomy and radiation. In addition, these trials usually provide for long-term follow-up care.
If you want additional information regarding breast cancer clinical trials, ask your doctor what trials may be open to you. And the following organizations may also be helpful:
National Alliance of Breast Cancer Organizations
Susan G. Komen Breast Cancer Foundation
CenterWatch Clinical Trials Listing Service
Journal of Clinical Oncology, August 2000; 18: 2805-2810
New England Journal of Medicine, December 30, 1999; 341:2061-2067 "African Americans and Breast Cancer," a symposium sponsored by the Magic Johnson Foundation, Sept. 14, 2000, New York, NY
The National Cancer Institute (http://www.nci.nih.gov)
Abstracts from the annual meeting of the American Society of Clinical Oncology, May 23, 2000, New Orleans, LA
Susan G. Komen Breast Cancer Foundation (http://www.komen.org)
Office of Research on Minority Health, National Institutes of Health
Drug Benefit Trends, 1999; 11(12):17-18
National Surgical Adjuvant Breast and Bowel Project (http://www.nsabp.pitt.edu)
National Cancer Institute clinical trials Web site (http://cancertrials.nci.nih.gov.)
Abstracts from the 17th Annual Miami Breast Cancer Conference, Miami, FL, March 3, 2000
American Cancer Society (www.cancer.org)
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