What side effects are associated with this type of intervention?

Common treatments for hot flashes include neurokinin blockers like Elinzanetant, selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and hormone replacement therapy (HRT). Neurokinin blockers, such as Elinzanetant, are being studied for their efficacy and safety, with potential side effects including nausea, headache, and fatigue. SSRIs and SNRIs can cause side effects like nausea, dizziness, dry mouth, and changes in appetite. HRT may lead to side effects such as breast tenderness, bloating, and an increased risk of blood clots and certain cancers. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

FDA-approved treatments for hot flashes primarily include hormone replacement therapies (HRT) such as estrogen and progestin combinations (e.g., Premarin). Non-hormonal options include selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), which have been shown to reduce the frequency and severity of hot flashes. While neurokinin blockers like elinzanetant are being studied for their efficacy in treating hot flashes, they are not yet FDA-approved for this indication. Other non-hormonal treatments under investigation include medications like esmirtazapine and alpha-methyldopa.

What other types of research exist?

Promising novel alternatives to Elinzanetant for treating hot flashes include: 1) Esmirtazapine, which has shown efficacy in reducing the frequency and severity of VMS in postmenopausal women in Phase III trials. 2) Estradiol in micellar nanoparticles (MNPEE), which has demonstrated effectiveness in managing moderate to severe VMS in a multicenter, randomized, double-blind, placebo-controlled study. These alternatives offer different mechanisms of action and delivery methods, providing additional options for patients and clinicians.

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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

Females aged 18 to 70 years of age inclusive, at the time of signing the informed consent

Must not have

Disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer diagnosed based on endometrial biopsy during screening

Current arterial or venous vascular event (e.g., Myocardial infarction (MI), Transient ischemic attack (TIA), stroke, deep vein thrombosis (DVT), i.e., within the last 6 months prior to signing informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 12

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called elinzanetant to help women with hormone-receptor positive breast cancer who suffer from hot flashes due to their treatment. The medication works by blocking signals that cause hot flashes. The study will compare elinzanetant to see how well it reduces hot flashes and if it is safe.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had hormone-receptor positive breast cancer or am at high risk for it.

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I am a woman aged between 18 and 70.

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I am taking Tamoxifen or Aromatase inhibitors for my cancer, with or without GnRH analogues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My biopsy showed abnormal endometrial growth or cancer.

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I haven't had a heart attack, stroke, or blood clot in the last 6 months.

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I have had breast cancer treatment, except hormone therapy, in the last 3 months.

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I have experienced unexplained vaginal bleeding.

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I have a history of heart rhythm problems.

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My breast cancer is hormone-receptor positive and either stage IV or recurred during hormone therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Body Weight Changes

Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12

Side effects data

From 2019 Phase 2 trial • 199 Patients • NCT03596762

12%

Diarrhoea

12%

Nausea

12%

Herpes zoster

12%

Headache

Fatigue

Bradycardia

Nephrolithiasis

Abdominal pain upper

Aspartate aminotransferase increased

Rash

Haematuria

Flatulence

Non-cardiac chest pain

Viral upper respiratory tract infection

Viral sinusitis

Blood creatine phosphokinase increased

Electrocardiogram QT prolonged

Liver function test increased

Joint swelling

Somnolence

Depressed mood

Insomnia

Breast tenderness

Cough

100%

80%

60%

40%

20%

Study treatment Arm

80 mg Elinzanetant (BAY3427080)

120 mg Elinzanetant (BAY3427080)

Placebo

40 mg Elinzanetant (BAY3427080)

160 mg Elinzanetant (BAY3427080)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~1940

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Elinzanetant, a neurokinin blocker, works by inhibiting neurokinin from sending signals that trigger hot flashes. This is significant because it offers a non-hormonal treatment option, which is particularly beneficial for women with hormone-receptor positive breast cancer who cannot use hormone therapy. Hormone therapy, another common treatment, alleviates hot flashes by supplementing estrogen and/or progesterone, but it carries risks such as increased chances of breast cancer and cardiovascular events. Non-hormonal treatments like SSRIs and SNRIs work by altering neurotransmitter levels to reduce hot flashes. Understanding these mechanisms helps patients and doctors choose the most appropriate and safe treatment based on individual health profiles and cancer risks.

Pooled Analysis of Six Pharmacologic and Nonpharmacologic Interventions for Vasomotor Symptoms.Is placebo as effective as estrogen regimens on vasomotor symptoms in women with surgical menopause?Assessing risks and benefits of nonhormonal treatments for vasomotor symptoms in perimenopausal and postmenopausal women.