NSABP Members' Area
  Password Protected - Access
  Limited to NSABP Participating
  Institutions Only


NSABP Foundation, Inc.



General NSABP Information
  Financial Conflicts of
     Interest Policy
  Coalition Comment:
     Reconfiguration
  IOM Report Group Comment
  Contact the NSABP
  Pathology Section
  Future Meetings
  NSABP Newsletters
  Media Info on STAR
  Employment

Clinical Trials Information
  Clinical Trials Overview
  Protocol Chart
  Never Say Lost

Treatment Trials Information
  Protocol B-43
  Protocol B-47
  Protocol B-51

Prevention Trials Information
  Protocol P-1 - BCPT
  Protocol P-2 - STAR
  Protocol P-5
  BreastCancerPrevention.com

Scientific Publications

Related Web Sites



Medical Search Engines



To report problems, ask
questions or make comments,
please send e-mail to:
Webmaster@nsabp.pitt.edu

Annotated Bibliography of NSABP Publications


Tamoxifen for the Prevention of Breast Cancer: Current Status of the National Surgical Adjuvant Breast and Bowel Project P-1 Study.
Fisher B, Costantino J, Wickerham DL, Cecchini RS, Cronin WM, Robidoux A, Bevers TB, Kavanah M, Atkins J, Margolese R, Runowicz CD, James J, Ford L, Wolmark N
J Natl Cancer Inst. 2005;97(22):1652-62.

Abstract
Background: Initial findings from the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial (P-1) demonstrated that tamoxifen reduced the risk of estrogen receptor-positive tumors and osteoporotic fractures in women at increased risk for breast cancer. Side effects of varying clinical significance were observed. The trial was unblinded because of the positive results, and follow-up continued. This report updates our initial findings.

Methods: Women (n = 13,388) were randomly assigned to receive placebo or tamoxifen for 5 years. Rates of breast cancer and other events were compared by the use of risk ratios (RRs) and 95% confidence intervals (CIs). Estimates of the net benefit from 5 years of tamoxifen therapy were compared by age, race, and categories of predicted breast cancer risk. Statistical tests were two-sided.

Results: After 7 years of follow-up, the cumulative rate of invasive breast cancer was reduced from 42.5 per 1000 women in the placebo group to 24.8 per 1000 women in the tamoxifen group (RR = 0.57, 95% CI = 0.46 to 0.70) and the cumulative rate of noninvasive breast cancer was reduced from 15.8 per 1000 women in the placebo group to 10.2 per 1000 women in the tamoxifen group (RR = 0.63, 95% CI = 0.45 to 0.89). These reductions were similar to those seen in the initial report. Tamoxifen led to a 32% reduction in osteoporotic fractures (RR = 0.68, 95% CI = 0.51 to 0.92). Relative risks of stroke, deep-vein thrombosis, and cataracts (which increased with tamoxifen) and of ischemic heart disease and death (which were not changed with tamoxifen) were also similar to those initially reported. Risks of pulmonary embolism were approximately 11% lower than in the original report, and risks of endometrial cancer were about 29% higher, but these differences were not statistically significant. The net benefit achieved with tamoxifen varied according to age, race, and level of breast cancer risk.

Conclusions: Despite the potential bias caused by the unblinding of the P-1 trial, the magnitudes of all beneficial and undesirable treatment effects of tamoxifen were similar to those initially reported, with notable reductions in breast cancer and increased risks of thromboembolic events and endometrial cancer. Readily identifiable subsets of individuals comprising 2.5 million women could derive a net benefit from the drug.