Safety/Efficacy of Q-122 in Breast Cancer Patients Taking Tamoxifen or Aromatase Inhibitor

Summary

This is a Phase 2 proof-of-concept (POC) study designed to determine the effectiveness of Q-122 for the treatment of Vasomotor Symptoms (VMS) versus placebo. Participants who meet all eligibility criteria following the Screening/Run-In period will be randomized to 1 of 2 treatment arms; blinded Q-122 or placebo for a period of 28 days. All participants will be followed for a 2-week, drug-free, follow-up period after their last dose of blinded Q-122/placebo before termination from the study.

Timeline

Start

2018-10-24

Primary completion

2020-07-29

Completion

2020-09-09

Outcome

Met primary endpoint

paper Q-122 resulted in a significantly greater mean percentage change in msVMS-SS from baseline over 28 days of treatment compared with placebo (least squares mean: Q-122 -39% [95% CI -46 to -31] vs placebo -26% [-33 to -18]; p=0·018). PMID 36366886 ↗

Publications

• Vrselja A, Latifi A, Baber RJ, Stuckey BGA, Walker MG, Stearns V, Hickey M, Davis SR. Q-122 as a novel, non-hormonal, oral treatment for vasomotor symptoms in women taking tamoxifen or an aromatase inhibitor after breast cancer: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2022 Nov 12;400(10364):1704-1711. doi: 10.1016/S0140-6736(22)01977-8.

Drugs

Indications

No indication recorded.