Originally published as JCO Early Release 10.1200/JCO.2004.03.005 on April 13 2004

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Factors Associated With Breast Cancer Clinical Trials Participation and Enrollment at a Large Academic Medical Center

From the Division of Hematology and Oncology, Karmanos Cancer Institute at Wayne State University School of Medicine, Detroit, MI.

Address reprint requests to Michael S. Simon, MD, MPH, Hudson Webber Cancer Research Building, 4th floor, 4100 John R. St, Detroit, MI 48201; e-mail: Simonm{at}karmanos.org

PURPOSE: The practice patterns of medical oncologists at a large National Cancer Institute Comprehensive Cancer Center in Detroit, MI were evaluated to better understand factors associated with accrual to breast cancer clinical trials.

PATIENTS AND METHODS: From 1996 to 1997, physicians completed surveys on 319 of 344 newly evaluated female breast cancer patients. The 19-item survey included clinical data, whether patients were offered clinical trial (CT) participation and enrollment, and when applicable, reasons why they were not. Multivariate analyses using logistic regression were performed to evaluate predictors of an offer and enrollment.

RESULTS: The patients were 57% white, 32% black, and 11% other/unknown race. One hundred six (33%) were offered participation and 36 (34%) were enrolled. In multivariate analysis, CTs were less likely offered to older women (mean age, 52 years for those offered v 57 years for those not offered; P = .0005) and black women (21% of blacks offered v 42% of whites; P = .0009). Women with stage 1 disease, poor performance status, and those who were previously diagnosed were also less likely to be offered trials. None of these factors were significant predictors of enrollment. Women were not offered trials because of ineligibility (57%), lack of available trials (41%), and noncompliance (2%). Reasons for failed enrollment included patient refusal (88%) and failed eligibility (12%).

CONCLUSION: It is important for cooperative groups to design studies that will accommodate a broader spectrum of patients. Further work is needed to assess ways to improve communication about breast cancer CT participation to all eligible women.

Supported in part by the National Action Plan on Breast Cancer Small Grant, Contract Number CA 95-016, the Barbara Ann Karmanos Cancer Institute Core Grant CA-22453, and the United Foundation of Detroit.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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