Challenges in monitoring the Breast Cancer Prevention Trial

Data Monitoring in Clinical Trials: A Case Studies Approach

Volumn , Issue , 2006, Pages 118-135

  Redmond, Carol K ^a   Costantino, Joseph P ^a   Colton, Theodore ^b  

^a UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH   (United States)

^b BOSTON UNIVERSITY SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84887899994     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1007/0-387-30107-0_11     Document Type: Chapter

References (12)

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2. Redmond CK, Costantino JP. Design and current status of the NSABP breast cancer prevention trial (BCPT). 1996. In SennHJ, Gelber RD, Goldhirsch A, Thurlimann B (ed.): Recent Results in Cancer Research. Springer, New York, 140:309-317.
3. Gail MH, Brinton LA, Byar DP, Corle DK, Green SB, Schairer C, Mulvihill JJ. 1989. Projecting individualized probabilities of developing breast cancer for white females who are being examined annually. J Natl Cancer Inst 81:1879-1886.
4. Fisher B, Costantino JP, Wickerham DL, Redmond CK, Kavanah M, Cronin WM, Vogel V, et al. 1998. Tamoxifen for prevention of breast cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst 90:1371-1388
5. Costantino JP, Gail MH, Pee D, Anderson S, Redmond CK, Benichou J, Wieand HS. 1999. Validation studies for models projecting the risk of invasive and total breast cancer incidence, J Natl Cancer Inst 91:1541-1548.
6. Gail MH, Costantino JP. Editorial. 2001. Validating and improving models for projecting the absolute risk of breast cancer. J Natl Cancer Inst 93:334-335.
7. Rosner B. 1999. Fundamentals of Biostatistics, ed 4, Boston, 1995, Duxbury Press.
8. Fleming TR, Harrington DP, O'Brien PC. 1984. Designs for group sequential tests. Control Clin Trials 5:348-361.
9. Freedman L, Anderson G, Kipnis V, Prentice R, Wang CY, Rossouw J, Wittes J, De Mets D. 1996. Approaches to monitoring the results of long-term disease prevention trials: Examples from the Women's Health Initiative. Control Clin Trials 17:509-525.
10. Fisher B, Redmond C, Dimitrov NV, Bowman D, Legault-Poisson S, Wickerham DL, Wolmark N, Fisher ER, Margolese R, Sutherland C, et al. 1989. A randomized clinical trial evaluating tamoxifen in the treatment of patients with node-negative breast cancer who have estrogen-receptor positive tumors. N Engl J Med 320:479-484.
11. Pavlidis N, Petris C, Briassoulis E, Klouvas G, Psilas C, Rempapis J, Petroutsos G. 1992. Clear evidence that long-term, low-dose tamoxifen treatment can induce ocular toxicity. A prospective study of 63 patients. Cancer 69:2961-2964.
12. Gorin MB, Day R, Costantino JP, Fisher B, Redmond CK, Wickerham L, et al. 1998. Longterm tamoxifen citrate use and potential ocular toxicity, Am J Ophthalmol 125:493-501.