This phase 2 trial will investigate the effectiveness of Q-122, an experimental drug to treat hot flashes in breast cancer (BC).
The main outcome will be the hot flash severity score (HFSS). This trial is recruiting in the United States and Australia.
Breast cancer (BC) is one of the most common cancers in women. Treatment may include hormonal therapy. Many women on hormonal therapy experience vasomotor symptoms (VMS). VMS includes ‘hot flashes'. These are usually treated with hormonal replacement (HR). Patients that undergo hormonal therapy cannot have HR. As a result, hot flashed are left untreated in this patient population.
This trial will investigate the effectiveness of Q-122, an experimental drug to treat hot flashes in BC. The main outcome will be the HFSS.
Who are they looking for?
This trial will recruit 130 women with a history of BC. Patients must be undergoing hormonal therapy with tamoxifen (Nolvadex) or an aromatase inhibitor and experience hot flashes. Patients taking a stable dose of thyroid medication or an SSRI/SNRI can take part in the trial.
Patients cannot take part if they are pregnant or breastfeeding. Patients must not be able to become pregnant. Patients with advanced BC or uncontrolled vaginal bleeding cannot take part. Other exclusion criteria are gastrointestinal, kidney or liver conditions that would affect drug action, uncontrolled blood pressure, abnormal blood lab results or a history of substance abuse.
How will it work
Participants will be randomly assigned to one of two groups. One group will receive Q-122 (100 mg tablet, twice daily). The control group will take a placebo (inactive) tablet twice daily. The study will last for 4 weeks.