Together, the BCPT
and STAR trials demonstrated that safety can be improved in iterative generations of agents and trials.
I have to ask, why aren't the results of the BCPT
and STAR trials more vigorously applied in clinical practice?
was stopped 14 months before planned because the Data and Safety Monitoring Board felt it was unethical to continue to allow one half of such high-risk participants to take placebo in light of the dramatic reduction in both invasive and noninvasive breast cancer among women who took tamoxifen.
Among patients who took tamoxifen in the BCPT
, there were 33 cases of endometrial cancer versus 14 cases in those who took placebo ("Breast Cancer," 1998).
She reported on 13,388 women at high risk for developing breast cancer who were randomized to tamoxifen or placebo in the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial (NSABP BCPT
These results contradict those found in the BCPT
that demonstrated a protective effect of tamoxifen in higher-risk patients.
Interim results of the BCPT
released in April showed 45% fewer cases of breast cancer among women who took tamoxifen than among those who took placebo.
Now, NCI and NSABP are embarking on a second prevention trial (STAR - Study of Tamoxifen and Raloxifene) testing raloxifene, a drug used to treat osteoporosis, against the proven safety and efficacy of Nolvadex in the reduction of breast cancer incidence as shown in the BCPT