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

摘要

The management of menopausal symptoms in women with a history of breast cancer poses a major therapeutic challenge. Hot flashes are a significantly bothersome symptom for many post-menopausal women and patients receiving drugs such as tamoxifen. The lack of effective agents for menopausal symptoms and the burgeoning interest in alternative modalities has led to an increasing use of herbal remedies despite a lack of objective data on safety and efficacy. Our originally proposal was for a clinical trial to assess feasibility, toxicity and preliminary efficacy analyses of an herbal regimen to ameliorate menopausal symptoms in individuals with a past history of breast cancer who are menopausal and experiencing hot flashes. The FDA required a preliminary phase I clinical trial in a group of 20 healthy women with no previous history of breast cancer to ensure there were no adverse estrogenic effects from the herbal regimen prior to commencing the clinical trial in women with a previous history of breast cancer. We have completed the phase I trial and enrolled a total of 30 women with no previous history of breast cancer.