Phase I/II Pilot Study to Assess Toxicity and Efficacy of Chinese Herbs to Treat Hot Flashed and Menopausal Symptoms for Women With a History of Breast Cancer

摘要

The goal of the study is to assess the safety and feasibility of a Chinese herbal formula, MF101, in alleviating hot flashes and other symptoms associated with menopause. Our group has experienced a delay in initiating the funded trial due to concerns raised by the Food and Drug Administration (FDA). In the original grant submitted to the Department of Defense (DoD), the population of women to be studied were women with a history of breast cancer. Because an Investigational New Drug License (IND) was obtained from the FDA for MF101, the herbal formula to be given to women participating in the study, the same grant application was submitted to the FDA. The primary concern addressed by the FDA was the potential estrogenic effects of MF101, specifically the relationship of estrogen and increased risk of breast cancer recurrence. The FDA placed a clinical hold on MF101, thereby delaying the study. Additionally, the FDA stated that safety data on hormonal drugs are obtained over a 30-day period and this time frame is enough to observe any physiologic or biological estrogenic changes. In short, it was agreed that the study would be conducted with healthy women over a 30-day period. Amendments to the protocol have been approved by the FDA. The Surgeon General's Human Subjects Research Review Board recently approved the above-mentioned changes, and suggested further edits to the protocol and consent form. These latter edits will be submitted to the DOD this week and, following final approval, will be submitted to the UCSF institutional Review Board. We hope to begin the study as soon as possible.