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Imlunestrant for Early Breast Cancer (EMBER-4 Trial)
EMBER-4 Trial Summary
This trial is testing whether immunestrant works better than standard hormone therapy for people with early breast cancer who are estrogen receptor positive and human epidermal receptor 2 negative.
EMBER-4 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEMBER-4 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.EMBER-4 Trial Design
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Who is running the clinical trial?
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- I finished or stopped my hormone therapy more than 6 months ago.I have had cancer before.I have taken medication (like tamoxifen or AIs) for breast cancer prevention.My breast cancer is early-stage, ER+ and HER2-, with no distant spread.I have had chemotherapy or targeted therapy for my cancer.I had a break of more than 6 months in my hormone therapy for cancer.My organs are functioning well.My breast cancer was advanced or inflammatory at diagnosis.I have not had breast cancer before, except for a specific type treated over 5 years ago.I have been on hormone therapy for my cancer for 2 to 5 years.My condition is at high risk of coming back based on its characteristics.I am fully active or restricted in physically strenuous activity but can do light work.
- Group 1: Investigator's Choice of Endocrine Therapy
- Group 2: Imlunestrant
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Can people with the prescribed illness sign up for this test currently?
"That is correct, the public information available on clinicaltrials.gov affirms that this trial is looking for more patients as of 11/9/2022. This particular study was first posted on 10/4/2022 and 100 sites are needed to reach their goal of 6000 participants."
How many participants will this research project be able to accommodate?
"That is correct, the information available on clinicaltrials.gov affirms that this study is still looking for volunteers. The trial was first advertised on October 4th of 2020 and has been updated as recently as November 9th, 2020. They are hoping to enroll 6000 individuals from 100 different locations."
Has the food and drug administration given Imlunestrant their seal of approval?
"Imlunestrant's safety is based on past clinical trials, and it received a score of 3."
Does this research have a broad geographic distribution in North America?
"Banner MD Anderson Cancer Center at McKee Medical Center in Loveland, Colorado, St. Joseph Hospital in Orange, California and Oregon Health and Science University in Portland, Oregon are all running this clinical trial with an additional 100 other medical centres."
Who else is applying?
How old are they?
What portion of applicants met pre-screening criteria?
What state do they live in?
How many prior treatments have patients received?
What site did they apply to?
Why did patients apply to this trial?
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