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Amcenestrant for Advanced Breast Cancer (AMEERA-3 Trial)
AMEERA-3 Trial Summary
This trial is testing a new drug, amcenestrant, to see if it is better than the current standard of care for treating metastatic or locally advanced breast cancer. The secondary objectives are to compare overall survival, objective response rate, disease control rate, clinical benefit rate, duration of response, and safety profile between the two treatment arms. The trial will also assess the pharmacokinetics of amcenestrant and evaluate health-related quality of life in both treatment groups.
AMEERA-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAMEERA-3 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AMEERA-3 Trial Design
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Who is running the clinical trial?
Media Library
- My cancer cannot be treated with radiation or surgery and may have spread.My cancer is estrogen receptor positive.I have significant difficulty with self-care.I haven't taken drugs that affect UGT in the last 2 weeks.I have had only one prior treatment for my advanced cancer.My breast cancer is diagnosed as adenocarcinoma.I have not taken strong CYP3A inducers in the last 2 weeks.I haven't taken mTOR inhibitors or SERDs, except fulvestrant, for 3 months.I am 18 years old or older.My cancer is not HER2 positive.My blood, clotting, kidney, and liver functions are not within normal ranges.I do not have any severe illnesses that are not under control.I have previously been treated with a CDK 4/6 inhibitor, if it's approved and covered for me.I have brain metastases that are either untreated, causing symptoms, or need treatment for symptoms.I haven't taken any cancer drugs in the last 3 weeks.I am currently taking medication that affects my body's drug transport system.My breast cancer worsened on hormone therapy after initial improvement.I have been cancer-free for over 3 years, except for certain skin cancers or in situ cervical cancer.I have no stomach or bowel problems that affect medication absorption.I am either male or female.
- Group 1: Fulvestrant/Aromatase inhibitors/Estrogen receptor modulator
- Group 2: Amcenestrant
- 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
Has Amcenestrant undergone FDA approval process?
"While there is some evidence of Amcenestrant's safety, it is classified as a Phase 2 drug because there is no data supporting efficacy."
For what reasons is Amcenestrant generally applied?
"Amcenestrant is frequently used to stop the worsening of a disease or condition. It is also approved by many regulatory bodies to treat conditions such as ovarian cancer, tamoxifen, and other malignant neoplasms."
How many volunteers are being sought for this experiment?
"Unfortunately, this study has completed recruitment for clinical trial candidates. Although, there are 2366 trials for breast cancer and 326 for Amcenestrant that are still admitting patients."
What is the precedent for Amcenestrant clinical trials?
"Currently, there are 326 ongoing clinical trials for Amcenestrant, with 87 of them in Phase 3. While most of the trials are located in Shanghai, there are a total of 18741 locations worldwide where clinical trials for Amcenestrant are taking place."
Are there numerous research sites for this project?
"There are 42 locations where this clinical trial is taking place. Some of these are: Investigational Site Number :8400020 in Baton Rouge, Investigational Site Number :8400022 in Fort Worth, and Investigational Site Number :8400034 in Iowa City."
Are we still recruiting individuals for this clinical research?
"As of right now, this clinical trial is not looking for new patients. According to the latest update on 4/28/2022, this study was first posted on 10/22/2019. If you are interested in other trials, there are 2366 trials for breast cancer and 326 trials for Amcenestrant that are currently recruiting."
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