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NCT03518138
Safety/Efficacy of Q-122 in Breast Cancer Patients Taking Tamoxifen or Aromatase Inhibitor
Phase 2 trial testing Q-122 in Vasomotor Symptoms (VMS) in 132 participants. Completed in 9 September 2020.
29 July 2020
Quick facts
| Lead sponsor | Que Oncology |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 132 |
| Start date | 24 October 2018 |
| Primary completion | 29 July 2020 |
| Estimated completion | 9 September 2020 |
| Sites | 18 locations across New Zealand, United States, Australia |
Drugs / interventions tested
- Q-122 — full drug profile →
- Placebo
Conditions studied
- Vasomotor Symptoms (VMS) — all drugs for Vasomotor Symptoms (VMS) →
Sponsor
Que Oncology — full company profile →
Who can join
Adults 18 to 70, female only, with Vasomotor Symptoms (VMS). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
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.
Vrselja A, Latifi A, Baber RJ, Stuckey BGA, et al · · 2022 · cited 13× · PMID 36366886 · DOI 10.1016/s0140-6736(22)01977-8 -
Targeting of G-protein coupled receptors in sepsis.
Rehman A, Baloch NU, Morrow JP, Pacher P, et al · · 2020 · cited 11× · PMID 32197794 · DOI 10.1016/j.pharmthera.2020.107529 -
Neurokinin receptor antagonists as potential non-hormonal treatments for vasomotor symptoms of menopause.
Conklin M, Santoro N. · · 2023 · cited 4× · PMID 37388717 · DOI 10.1177/26334941231177611
Verify or expand the search:
- PubMed search for NCT03518138
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Vasomotor Symptoms (VMS)
Currently open trials in the same condition.
- NCT06957691 — Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Pro · Phase 2 · recruiting
Other Que Oncology trials
Trials by the same sponsor.
- NCT04080297 — Dose Escalation Study in Female Subjects With Breast Cancer Receiving Aromatase Inhibitor or Tamoxifen · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03518138 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Que Oncology
- Last refreshed: 23 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03518138.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing