Non-hormonal oral therapy for breast cancer patients

QUE Oncology has announced the results of its Phase II trial of Q-122, a novel non-hormonal oral therapy for the treatment of vasomotor symptoms (commonly known as hot flashes/flushes and night sweats) in women taking endocrine therapy for breast cancer, have been published in The Lancet.

More than 75% of breast cancers are hormone-sensitive, with endocrine therapy being the standard treatment option according to Breast Cancer Network Australia. Endocrine therapy is recommended for 5–10 years after cancer treatment for those women that had hormone-sensitive breast cancer, to prevent disease recurrence. However, approximately 70% of women taking endocrine therapy have vasomotor symptoms that contribute to over one-third of women prematurely stopping this important therapy.

The Phase II study was a multicentre, randomised, double-blind, placebo-control trial involving 131 women, aged 18–70 years, taking a stable dose of tamoxifen or an aromatase inhibitor following breast cancer and experiencing at least 50 self-reported moderate to severe vasomotor symptoms per week.

Q-122 therapy significantly reduced the frequency and severity of moderate and severe vasomotor symptoms, with associated improvement in quality of life, compared with placebo. Q-122 was well tolerated with no serious adverse effects.

These results demonstrate the promise of Q-122 as a novel and differentiated, non-hormonal treatment of vasomotor symptoms for women with breast cancer taking endocrine therapy, and the potential for its use in post-menopausal women experiencing similar symptoms, according to QUE Oncology.

“In addition to a reduction in flushes and sweats, women who received Q-122 in the study reported a significantly lower likelihood of their hot flushes and sweats interfering with their sleep and social and leisure activities compared with placebo. If Q-122 can provide relief from these symptoms, it holds great potential for reducing discontinuation of endocrine therapy, enabling ongoing protection against breast cancer recurrence. This is an extremely important potential benefit of Q-122 beyond symptom relief alone,” said Professor Susan Davis, Principal Investigator and Senior Author, Director of the Monash University Women’s Health Research Program.

The results of QUE Oncology’s Phase II study support the conduct of larger and longer studies of Q-122, with potential use extending to postmenopausal women who require an alternative to oestrogen therapy for vasomotor symptoms.

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