Clinical stage biotechnology company QUE Oncology today has announced the launch of its Phase 2 trials that will see its novel non-hormonal therapy, for women with breast cancer suffering hot flushes and night sweats, tested at six sites across Australia.
QUE Oncology, which has already progressed clinical development of its lead drug program Q-122 through four Phase 1 trials, will now move the investigative therapy into a pivotal proof-of-concept trial across sites in Australia and the US to examine its efficacy.
The placebo-controlled, double-blind study will see a total of 130 women take part, with the trial expected to take up to eight months to complete.
After a diagnosis of breast cancer, women are routinely prescribed drugs such as tamoxifen or aromatase inhibitors (known as endocrine therapy) which reduce or block the action of estrogen, a hormone known to stimulate the growth of breast cancer.
According to the company, the side effect of reducing estrogen is an increased likelihood of moderate to severe hot flushes and night sweats.
"These symptoms can severely impact a women’s general wellbeing and often cause women to stop taking their breast cancer treatment. QUE Oncology is looking to develop a therapy to address these debilitating symptoms," it said.
"Previous trials with Q-122 have shown an excellent safety profile in over 60 patients and healthy volunteers. In a previous Phase 1b trial in women undergoing estrogen reduction therapy for breast cancer, 85% of women showed a reduction in both the frequency and severity of their hot flushes," it added.
“Evidence shows that up to 75% of women undergoing long-term preventative breast cancer treatment suffer hot flushes and night sweats, with some facing more than 20 events in one day," said QUE Oncology CEO Dr Rob Crombie.
"We expect through our Phase II trials to replicate the data that we have already seen in this patient group as we develop a treatment to substantially improve the quality of life for women on long-term endocrine therapy.”