Evaluating the effectiveness and safety of Q-122 for menopausal symptoms in women with breast cancer taking hormonal treatment

The study evaluated the effectiveness and safety of Q-122, a new non-hormonal oral treatment for menopausal symptoms in women with breast cancer taking hormonal therapy. The study found that Q-122 is effective and safe in treating menopausal symptoms in these patients.

The treatment for hormone receptor-positive breast cancer commonly involves hormonal therapy. In these patients, the cancer grows in response to female sex hormones such as estrogen and progesterone. Hormonal treatments such as tamoxifen (Novaldex) or aromatase inhibitors (AIs) block the actions of these hormones and stop the growth and spread of breast cancer cells.

However, many women start experiencing menopausal symptoms with these treatments. Menopausal (vasomotor) symptoms include night sweats and hot flashes which cause many women to stop taking the treatment. Menopausal hormone replacement therapy can treat vasomotor symptoms. However, this therapy is not recommended for women with hormone receptor-positive breast cancer. Therefore, non-hormonal treatments are being studied to help women with vasomotor symptoms.

Q-122 is a new oral, non-hormonal medication that plays a role in reducing the frequency of a specific type of nerve cell that causes vasomotor symptoms. It is important to evaluate the effectiveness and safety of Q-122 in managing vasomotor symptoms in women with breast cancer treated with hormone therapy.

The study involved 131 patients with breast cancer treated with tamoxifen or an AI. All women were experiencing vasomotor symptoms. Patients were randomly assigned into two groups. Group 1 included 65 patients who received Q-122 treatment twice a day for 28 days. Group 2 received a placebo twice a day for 28 days. 

After 28 days of treatment, Q-122 proved to have a greater reduction (by 39%) in vasomotor symptoms compared to the placebo group (by 26%).

The occurrence of side effects was similar between groups (17% in group 1 and 14% in group 2). The main side effects that made patients stop the treatment were hot flushes and inflammation of the pancreas. These were mild and were resolved after the drugs were stopped. 

The study showed that Q-122 showed promising effectiveness in improving vasomotor symptoms and was well tolerated. 

The study included a small sample of participants and had a very short duration. Larger and longer-term studies are needed. This study was funded by QUE Oncology, the manufacturer of Q-122.