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Elinzanetant for Hot Flashes in Breast Cancer Patients (OASIS-4 Trial)
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.
OASIS-4 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowOASIS-4 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 2 trial • 199 Patients • NCT03596762OASIS-4 Trial Design
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Who is running the clinical trial?
Media Library
- 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.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.You have to keep a diary of your hot flashes for at least 11 days before the study starts, and you should have experienced at least 35 moderate to severe hot flashes over the last 7 days of the diary.I have had breast cancer treatment, except hormone therapy, in the last 3 months.I have experienced unexplained vaginal bleeding.My recent mammogram or ultrasound shows signs of cancer needing treatment.I have a history of heart rhythm problems.I have not had any cancer except for certain skin cancers or hormone-receptor positive breast cancer in the last 5 years.I am a woman aged between 18 and 70.I am taking Tamoxifen or Aromatase inhibitors for my cancer, with or without GnRH analogues.My breast cancer is hormone-receptor positive and either stage IV or recurred during hormone therapy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
- Group 1: Elinzanetant (BAY3427080)
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Frequently Asked Questions
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."
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."
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."
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."
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)."
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