Evaluate RCN3028 in Treatment of Drug-Induced VMS in Breast Cancer
Status:
Terminated
Trial end date:
2022-04-20
Target enrollment:
Participant gender:
Summary
Due to the fact that majority of breast cancers are estrogen-receptor and/or progesterone
receptor positive, tamoxifen and aromatase inhibitors (AIs) are among the mainstay therapies
to treat breast cancer. Prior clinical studies of tamoxifen suggested that up to 80 % of
patients experienced hot flashes during therapy with tamoxifen, and 30 % defined their
symptoms as severe. Despite the high efficacy of tamoxifen, the harmful side effects have
been identified in previous studies as a significant reason for not persisting with the
treatment in 16 - 30 % of breast cancer patients.
The primary purpose of this study is to determine if RCN3028 is effective and safe in the
treatment of moderate to severe vasomotor symptoms associated. In accordance with the latest
FDA guidance study participants will have a minimum of 7 moderate to sever hot flashes per
day, or 50 per week at baseline.