Elinzanetant for Hot Flashes in Breast Cancer Patients

(OASIS-4 Trial)

Recruiting at 179 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

473 Participants Needed

Trial Summary

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.

How does the drug Elinzanetant differ from other treatments for hot flashes in breast cancer patients?

Elinzanetant is unique because it is a non-hormonal treatment option for hot flashes, which is important for breast cancer patients who often cannot use hormone-based therapies due to their cancer history. Unlike traditional treatments like venlafaxine or gabapentin, Elinzanetant may offer a novel mechanism of action, potentially providing relief without the side effects associated with hormonal treatments. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

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.

My biopsy showed abnormal endometrial growth or cancer.

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

Timeline

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

Treatment Details

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.

Participant Groups

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

References

1. France pubmed.ncbi.nlm.nih.gov

[Management of hot flushes for breast cancer survivors]. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Metabolic activity in the insular cortex and hypothalamus predicts hot flashes: an FDG-PET study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Hot flash management: update of the evidence for patients with cancer [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Hot flashes in breast cancer survivors. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Venlafaxine in management of hot flashes in survivors of breast cancer: a randomised controlled trial. [2015]