Novel Agents and Treatment Regimens for Breast Cancer
Our group has sought to advance the treatment of women with breast cancer through basic laboratory research, clinical trials, and correlative studies. We have conducted clinical treatment studies investigating the use of novel agents, innovative schedules, and combinations of established agents. Our group was the first to investigate the combination of trastuzumab and vinorelbine - a highly active and now standard therapy for women with HER2-positive advanced breast cancer. This combination is currently being investigated in the neoadjuvant, adjuvant, and metastatic settings. We also conducted some of the early trials of weekly taxane therapy. In the neoadjuvant setting, we have investigated various agents and combination regimens, including weekly trastuzumab with taxanes, vinorelbine, and letrozole. In addition, we studied novel intravenous agents such as the epothilone analogs, CCI-779, flavopiridol, and bevacizumab. Other clinical trials have investigated a number of new oral hormonal, chemotherapeutic, and biologic agents as well as their combinations, including ERA-923, UFT plus leucovorin, 5-fluorouracil (5-FU) plus eniluracil, oral vinorelbine, and OSI-776. To complement our treatment trials, we also have performed correlative basic science studies, which have sought to characterize HER2 signaling, assess markers of resistance, monitor response to therapy, and measure microscopic tumor burden. Other investigations have assessed patient compliance with oral chemotherapeutic regimens, evaluated patient attitudes and interest in participating in clinical trials, developed therapeutic agents and interventions to improve symptom control, and compared quality of life between various treatment options.