A Phase I Trial of Tibetan Medicine for Advanced Breast Cancer Principal investigator: Debasish Tripathy, UCSF co-investigators: Y. Donden, M. Wolf, L.Tenzig, M. Tagliaferri, H. Rugo, UCSF and Alternative Resources, Seekonk, MA. Abstract #A-32 Traditional Tibetan Medicine (TM) relies on a diagnostic assessement including the pulse, tongue and urine as well as herbal and dietary therapies. No pre-clinical models exist for traditional medicines such as TM. The anecdotal effectiveness of TM for advanced metastatic breast cancer (MBC) has never been formally confirmed in a prospective clinical trial. We chose to evaluate the safety and feasibility of TM when administered in a manner closely resembling traditional practice as conducted by a recognized expert practitioner ( co-author YD). For regulatory and logistical reasons, an Investigational New Drug License was obtained on 7 of numerous herbal formulae typically used by YD for MBC. Each formula contains 8 to 35 single herbal agents. Patients received TM as sole therapy and the protocol was later amended to include patients who were stable or slowly progressing on hormonal therapy. Based on the patient's history and TM examination, 2 to 4 forumulae were chosen by YD and given 4 times a day. TM examination was repeated by YD every 3-4 months with changes in the formula as needed. Baseline and every 3 month tumor measurements were performed as well as monthly examinations and safety assessments. Patients were continued on TM until tumor progression or until completion of the one-year study period. Eleven patients were enrolled and none experienced Grade III or IV toxicities attributable to the herbal therapy. Of 9 patients evaluable for response,1 had a partial response and 1 had stable disease for greater than 1 year. TM can be safely administered and trials to assess alternative medicine (AM) are feasible. Further studies and refinement of trial design will be necessary to ultimately assess the benefits of many commonly used alternative medicine approaches. Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.