Phase III, large-scale chemoprevention trials. Approach to chemoprevention clinical trials and phase III clinical trial of tamoxifen as a chemopreventive for breast cancer--the US National Cancer Institute experience.
Clinical trials to evaluate interventions for cancer prevention are designed as early (phase I, IIa, and IIb) or late-phase studies. Whereas the former are small and generally rely on intermediate endpoint biomarkers of carcinogenesis, the latter are large-scale, long-term, randomized, phase III studies that address endpoints such as cancer incidence. The Breast Cancer Prevention Trial, P-1, conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP), is discussed as an example of a large, extended, phase III trial designed to answer the question of whether tamoxifen reduces the incidence of breast cancer in women who are at increased risk for the disease.
Dunn
B K
BK
Division of Cancer Prevention, National Cancer Institute, Rockville, Maryland, USA.
Kramer
B S
BS
Ford
L G
LG
D001943:Breast Neoplasms / Q000188:drug therapy / Q000517:prevention & control; D018890:Chemoprevention; D017326:Clinical Trials, Phase III as Topic / Q000379:methods*; D005260:Female; D006801:Humans; D009316:National Institutes of Health (U.S.); D013629:Tamoxifen / Q000627:therapeutic use; D014481:United States
D013629:Tamoxifen