HPLC/PDA methodology was developed for phytoestrogen analysis in human blood, urine, and breast milk. Applications of this technique in four different observational studies showed that urinary excretion rates of isoflavonoids reflects soy consumption reliably. A case-control study in Shanghai showed a decrease in risk to develop breast cancer for women with high urinary isoflavone excretion. These findings support a potential breast cancer preventive effect achieved by soy consumption in populations that eat soy foods habitually.