Elinzanetant for Hot Flashes in Breast Cancer Patients

(OASIS-4 Trial)

Not currently recruiting at 212 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Bayer

Must be taking: Tamoxifen, Aromatase inhibitors

Disqualifiers: Metastatic cancer, Arrhythmias, Vaginal bleeding, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 36

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if elinzanetant can help women with hormone-receptor positive breast cancer who experience hot flashes due to their cancer treatment. Elinzanetant blocks signals in the body believed to trigger these hot flashes. Participants will receive either elinzanetant or a placebo, which resembles the medicine but contains no active ingredients, to compare effectiveness. Women who have had breast cancer or are at high risk and experience frequent hot flashes from their current cancer therapy might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current anti-cancer medications. In fact, participants will continue their existing anti-cancer therapy throughout the study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that elinzanetant is generally well-tolerated for treating hot flashes. Studies have found that it effectively reduces the frequency and severity of these symptoms, improving quality of life. Importantly, data from previous trials show a good safety record, indicating that serious medical problems related to the treatment are rare. Most participants experienced only mild side effects, if any. These findings suggest that elinzanetant is a safe option for managing hot flashes, even for women undergoing cancer treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hot flashes?

Elinzanetant is unique because it targets hot flashes in breast cancer patients, offering a non-hormonal approach. Most treatments for hot flashes involve hormone replacement therapy, which isn’t suitable for breast cancer patients due to the risk of hormone-sensitive cancer recurrence. Elinzanetant works by blocking neurokinin receptors, which are believed to play a role in regulating body temperature, providing a promising alternative without the hormonal risks. Researchers are excited about this treatment because it could offer relief without compromising cancer treatment safety.

What evidence suggests that elinzanetant might be an effective treatment for hot flashes in breast cancer patients?

Research has shown that elinzanetant, which participants in this trial may receive, can significantly reduce the number and intensity of hot flashes in women undergoing hormone therapy for breast cancer. Specifically, studies found that women taking elinzanetant experienced over a 73% decrease in hot flashes and night sweats. Elinzanetant works by blocking certain signals in the brain that cause hot flashes. This treatment not only reduces the number of moderate-to-severe symptoms each day but also helps improve sleep problems. Overall, elinzanetant has proven safe and effective for managing hot flashes related to hormone therapy. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am a woman with hot flashes due to hormone therapy for cancer, which I will continue during the study.

Contraceptive use by women except for post-menopausal women or Women of Non childbearing potential (WONCBP) should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion Criteria

I don't have any conditions that could confuse my vital sign readings.

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

My biopsy showed abnormal endometrial growth or cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either elinzanetant or placebo for 12 weeks, followed by elinzanetant for 40 weeks

52 weeks

12 visits (in-person), 6 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment for an additional 2 years

2 years

Visits every 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Elinzanetant
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Elinzanetant (BAY3427080) Experimental Treatment 1 Intervention

Participants will receive 120 mg elinzanetant orally once daily.

Group II: Placebo Placebo Group 2 Interventions

Participants will receive matching placebo orally once daily for 12 weeks, followed by 120 mg elinzanetant orally once daily

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Citations

1. nejm.org nejm.org/doi/10.1056/NEJMoa2415566

Elinzanetant for Vasomotor Symptoms from Endocrine ... Elinzanetant led to a significantly lower frequency of vasomotor symptoms associated with endocrine therapy than placebo. (Funded by Bayer; ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40454634/

Elinzanetant for Vasomotor Symptoms from Endocrine ... Elinzanetant led to a significantly lower frequency of vasomotor symptoms associated with endocrine therapy than placebo.

3. newsroom.uvahealth.com newsroom.uvahealth.com/2025/09/16/drug-reduces-hot-flashes-by-73-trial-finds/

Drug Reduces Hot Flashes by 73%, Trial Finds Elinzanetant recipients saw a more than 73% reduction in the frequency and severity of “vasomotor symptoms” – hot flashes and night sweats – by ...

4. esmo.org esmo.org/oncology-news/elinzanetant-leads-to-a-significantly-lower-frequency-of-vasomotor-symptoms-associated-with-endocrine-therapy-for-hr-positive-breast-cancer

Elinzanetant Leads To a Significantly Lower Frequency of ... Elinzanetant led to a significantly lower daily frequency of moderate-to-severe vasomotor symptoms, a greater decrease in sleep disturbances, and a greater ...

5. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2838538

Elinzanetant for the Treatment of Vasomotor Symptoms ... In this study, elinzanetant demonstrated a favorable efficacy and safety profile in treating moderate to severe VMS symptoms associated with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12418220/

Elinzanetant for the Treatment of Vasomotor Symptoms ... In this study, elinzanetant demonstrated a favorable efficacy and safety profile in treating moderate to severe VMS symptoms associated with ...

7. bayer2019tf.q4web.com bayer2019tf.q4web.com/news/news-details/2024/Data-from-Phase-III-study-OASIS-3-support-efficacy-and-long-term-safety-of-investigational-compound-elinzanetant-in-the-treatment-of-moderate-to-severe-vasomotor-symptoms-associated-with-menopause/default.aspx

Data from Phase III study OASIS 3 support efficacy and long ... OASIS 3 is a Phase III efficacy and long-term safety study of elinzanetant for the treatment of vasomotor symptoms (VMS, also known as hot flashes) associated ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211525000594

Efficacy and safety of elinzanetant in vasomotor symptoms ... Elinzanetant reduces the frequency and intensity of VMS and enhances quality of life and sleep quality in patients with menopause-related symptoms.