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Neurokinin Antagonist

Elinzanetant for Hot Flashes in Breast Cancer Patients (OASIS-4 Trial)

Phase 3
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women must have a personal history of hormone-receptor positive breast cancer or a high risk for developing breast cancer
Women experiencing vasomotor symptoms (VMS) caused by adjuvant endocrine therapy that they are expected to use for the duration of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 52
Awards & highlights

OASIS-4 Trial Summary

This trial is looking for a better way to treat women with, or at risk of, HR+ breast cancer who have hot flashes due to anti-cancer therapy. They will compare elinzanetant to placebo & assess changes in number & severity of hot flashes over 12 wks & safety.

Who is the study for?
Women aged 18-70 with a history of hormone-receptor positive breast cancer or at high risk for it, experiencing hot flashes due to anti-cancer therapy. They must have recorded a significant number of moderate to severe hot flashes in the weeks before joining and agree to use contraception if applicable.Check my eligibility
What is being tested?
The trial is testing Elinzanetant, which aims to reduce hot flashes by blocking neurokinin signals. Participants will either receive Elinzanetant or a placebo while continuing their current anti-cancer therapy, then switch after 12 weeks. The study lasts about 62 weeks with regular health checks.See study design
What are the potential side effects?
Potential side effects are not detailed but will be monitored throughout the trial. These include any new medical problems that arise during treatment, which could range from mild symptoms to more serious conditions affecting various body systems.

OASIS-4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had hormone-receptor positive breast cancer or am at high risk for it.
Select...
I am a woman with hot flashes due to hormone therapy for cancer, which I will continue during the study.
Select...
I am a woman aged between 18 and 70.
Select...
I am taking Tamoxifen or Aromatase inhibitors for my cancer, with or without GnRH analogues.

OASIS-4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD)
Hot flushes
Secondary outcome measures
Mean change in frequency of moderate to severe HF from baseline over time (assessed by HFDD)
Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD)
Body Weight Changes
+3 more

Side effects data

From 2019 Phase 2 trial • 199 Patients • NCT03596762
12%
Diarrhoea
12%
Nausea
12%
Herpes zoster
12%
Headache
6%
Bradycardia
6%
Nephrolithiasis
6%
Fatigue
6%
Abdominal pain upper
6%
Aspartate aminotransferase increased
6%
Rash
6%
Haematuria
6%
Flatulence
6%
Non-cardiac chest pain
6%
Viral upper respiratory tract infection
6%
Viral sinusitis
6%
Blood creatine phosphokinase increased
6%
Electrocardiogram QT prolonged
6%
Liver function test increased
6%
Joint swelling
6%
Somnolence
6%
Depressed mood
6%
Insomnia
6%
Breast tenderness
6%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
80 mg Elinzanetant (BAY3427080)
120 mg Elinzanetant (BAY3427080)
40 mg Elinzanetant (BAY3427080)
Placebo
160 mg Elinzanetant (BAY3427080)

OASIS-4 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Elinzanetant (BAY3427080)Experimental Treatment1 Intervention
Participants will receive 120 mg elinzanetant orally once daily.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo orally once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elinzanetant (BAY3427080)
2022
Completed Phase 3
~1870

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,229 Previous Clinical Trials
25,324,964 Total Patients Enrolled
13 Trials studying Hot Flashes
3,131 Patients Enrolled for Hot Flashes

Media Library

Elinzanetant (Neurokinin Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05587296 — Phase 3
Elinzanetant (Neurokinin Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05587296 — Phase 3
Hot Flashes Research Study Groups: Elinzanetant (BAY3427080), Placebo
Hot Flashes Clinical Trial 2023: Elinzanetant Highlights & Side Effects. Trial Name: NCT05587296 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical experiment include individuals beyond the age of 70?

"This trial stipulates that the minimum age of eligible patients is 18 and the upper limit of enrollment is 70."

Answered by AI

To what extent is the clinical trial being populated by participants?

"Indeed, according to clinicaltrials.gov the trial was first unveiled on October 14th 2022 and is currently still seeking 405 participants from 3 different medical sites."

Answered by AI

Are there any available vacancies in this trial for participants?

"Affirmative. Clinicaltrials.gov reveals that recruitment for this research study, which was made available on October 14th 2022, is ongoing with 405 participants required from 3 locations."

Answered by AI

Could you please provide an overview of the risks associated with Elinzanetant (BAY3427080) intake?

"Our team at Power determined that Elinzanetant (BAY3427080) is likely safe based on its Phase 3 status, which indicated the presence of clinical efficacy and safety data. This was given a score of 3."

Answered by AI

Who qualifies to partake in this medical experiment?

"This medical trial is enrolling 405 participants who are between 18 to 70 years old and experience hot flashes. Eligible patients must be female, expriencing vasomotor symptoms due to hormone therapy, have a personal history of hormone-receptor positive breast cancer or an elevated risk for developing it, complete the Hot Flash Daily Diary for 11 days in two weeks prior to baseline visit, record at least 35 moderate/severe hot flash incidents over last 7 days, and use contraception methods consistent with local regulations (if applicable)."

Answered by AI
~196 spots leftby Mar 2025