Here's the last part:
PUBLIC CONCERNS
25. Was any special effort made to include minority women on the trial?
Throughout the trial, several strategies were used to increase participation of women from racial and ethnic minority groups. These strategies included placing study-related recruitment materials in businesses and churches located in minority communities; collaborating with a minority-owned public relations firm to develop a structured media campaign targeting racial and ethnic minorities; developing and broadly disseminating a Public Service Announcement that featured singer Nancy Wilson; and communicating information to study sites about how other sites successfully reached racial and ethnic minorities.
When the early strategies did not attract sufficient numbers of minority participants, the NSABP launched the Pilot Minority Recruitment Program in August 1996. The goal of the program was to increase participation by increasing awareness and educating minority populations about the trial. A multidimensional approach was used: Community Outreach Coordinators employed at five BCPT sites offered personalized presentations on breast cancer risk factors, incidence, and survival rates, and on clinical trial research at African-American churches, community hospitals and health clinics, health fairs, public housing sites, businesses, and local chapters of sororities, the Urban League, and minority medical societies. In less than a year, these strategies enabled the coordinators to establish many relationships in their communities. As a result of these efforts, the number of Risk Assessment Forms submitted by minority groups increased, and during this period, the BCPT experienced the highest level of randomizations from racial and ethnic minority groups since the trial began. The Pilot Minority Recruitment Program has been the most effective strategy to date and will serve as the model for minority recruitment for future prevention trials.
ÿ
26. Will the study results be published?
Further analyses of the data are under way. A manuscript will be prepared and submitted to a peer-reviewed journal.
ÿ
27. Based on the BCPT results, should women who are at increased risk of breast cancer take tamoxifen?
Women who are at increased risk of breast cancer now have the option to consider taking tamoxifen to reduce their chances of developing breast cancer. As with any medical procedure or intervention, the decision to take tamoxifen is an individual one in which the benefits and risks of the therapy must be considered. The balance of these benefits and risks will vary depending on a woman's personal health history and how she weighs the benefits and risks. Therefore even if a woman is at increased risk of breast cancer, tamoxifen therapy may not be appropriate for her. Women who are considering tamoxifen therapy should talk with their health care provider.
ÿ
28. How can a woman learn more about the next breast cancer prevention trial?
The NSABP is planning a new breast cancer prevention trial, tentatively scheduled to begin in fall 1998. The trial would involve postmenopausal women who are at least 35-years-old and are at increased risk for developing breast cancer. The study would compare tamoxifen to another drug.
There are several ways to be placed on a mailing list for more information on this upcoming trial - by Internet, by mail, or by fax. On the Internet, the NSABP homepage nsabp.pitt.edu has a form available. By regular mail, send a letter or post card with name, mailing address, and a note specifying interest in future breast cancer prevention trials to: NSABP, Box 21, Pittsburgh, Pa. 15261. Or fax the same information to NSABP at (412) 330-4664. When information about the next prevention trial is available, it will be mailed to the people on this list.
ÿ
29. How does a woman determine whether she is at increased risk of breast cancer?
BCPT participants had their risk for developing breast cancer calculated using age, family history, and medical information in a computer program that also estimated their likelihood of developing heart disease, endometrial cancer, and blood clots. Some private physicians use computer calculations in their practice to assess breast cancer risk, but because these are not identical to the program used in the BCPT, it is unclear how well those programs would identify women at increased risk. The NSABP and NCI plan to make information available which will assist a woman and her health care provider to determine whether her risk is comparable to the women who participated in the BCPT.
ÿ
30. Will women with breast cancer gene alterations (BRCA1 and BRCA2) benefit from tamoxifen?
These two breast cancer gene alterations, which increase a woman's risk of the disease, were first identified after the BCPT began. Using blood samples taken from participants, analyses are under way to determine whether tamoxifen has the same relative effects on women whether or not they carry alterations in these genes. To maintain strict confidentiality, samples in this study have no identifying labels that could link them to individual women. Therefore, researchers will not be able to give individual results to a participant or her health care provider.
ÿ
31. Is tamoxifen a good substitute for hormone replacement therapy?
No. Every woman has individual health risks that affect her need for interventions such as hormone replacement therapy or tamoxifen therapy. Hormone replacement therapy is intended to help women maintain bone density. It may also reduce the risk of heart disease in postmenopausal women, and many women benefit from a reduction in hot flashes and other problems that can affect quality of life. Some studies have suggested that hormone replacement therapy increases a woman's chances of developing breast cancer.
The BCPT results show that tamoxifen reduces breast cancer risk and may help slow or reduce bone loss, as evidenced by the reduced number of bone fractures, but it did not decrease heart disease risk. A woman with a large risk of heart disease may not have the same benefit from tamoxifen as from hormone replacement therapy.
ÿ
32. Should women who are not at a demonstrated increased risk of breast cancer consider taking tamoxifen?
This question has not been studied. At this time, there is no evidence that tamoxifen is beneficial for women who do not have an increased risk of breast cancer.
ÿ
33. Are there any women who should not take tamoxifen?
Animal studies have suggested that the use of tamoxifen during pregnancy might harm the fetus. Women who were pregnant or who planned to become pregnant were not eligible to participate in the BCPT. Premenopausal women participating in the BCPT were required to use some method of birth control other than oral contraceptives ("the pill") while taking tamoxifen. Oral contraceptives may change the effects of tamoxifen and may also affect the risk of breast cancer.
Women with a history of blood clots, hypertension, diabetes, and cigarette smoking must also consider that tamoxifen increases the risk for serious blood clots.
ÿ
34. How much does a standard dose of tamoxifen cost?
A month's supply of tamoxifen costs about $80 to $100.
ÿ
35. How much did the study cost?
The trial had been projected to cost $70 million, but the total cost is estimated at $50 million, including $10 million for two more years of follow-up. All except $3.5 million from the National Heart, Lung, and Blood Institute, was provided by NCI.
ÿ
36. Why is the Breast Cancer Prevention Trial so important?
This year, more than 178,000 women in the United States alone will be diagnosed as having breast cancer, and about 43,500 will die of the disease. For many years, women at increased risk for developing breast cancer had no proven means to reduce their risk. Women had to rely on frequent checkups and periodic mammograms to detect breast cancer at an early stage. Doctors sometimes suggest that certain women at very high risk have preventive (prophylactic) mastectomies, which is surgery to remove breast tissue before cancer develops. However, the operation does not guarantee that breast cancer will be avoided, because it is almost impossible to remove all the breast tissue and the impact of prophylactic mastectomy on breast cancer risk is not known.
Because tamoxifen was successful in reducing the incidence of breast cancer, women at increased risk for developing the disease will have a choice other than more frequent exams or major surgery. Tamoxifen does not replace the need for regular mammography. In order to prove its value, tamoxifen had to be tested in a large research study to determine whether the benefits outweighed the risks.
ÿ
37. What is the National Surgical Adjuvant Breast and Bowel Project?
The NSABP is a cooperative group with a 40-year-history of designing and conducting clinical trials, the results of which have changed the way breast cancer is treated, and now, potentially prevented. Results of research studies conducted by NSABP researchers have been the dominant force in altering the standard surgical treatment of breast cancer from radical mastectomy to lumpectomy plus radiation. This group was also the first to demonstrate that adjuvant therapy could alter the natural history of breast cancer, thus increasing survival rates. When a breast cancer prevention study was initially conceived, more than 30,000 women with breast cancer had participated in treatment studies conducted by NSABP investigators. A research study to prevent breast cancer was a logical next step for this research group.
NSABP was recently incorporated under the aegis of the NSABP Foundation, Inc., a Pennsylvania nonprofit membership organization with nearly 300 members in the United States, Canada, and Australia. More than 6,000 physicians, nurses, and other medical professionals in the NSABP, located in member institutions and their satellites are involved in the conduct of treatment and prevention trials. NCI provides funding for the two headquarters components of NSABP: the NSABP Operations Center at Allegheny University of the Health Sciences, Allegheny Campus, and the NSABP Biostatistical Center at the University of Pittsburgh, both located in Pittsburgh, Pa. NCI also provides funding directly or indirectly, to the medical center Members of the NSABP Foundation, Inc., who are responsible for implementation of NSABP studies. |
