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Aromatase Inhibitors + Abemaciclib for Breast Cancer (MONARCH 3 Trial)
MONARCH 3 Trial Summary
This trial will compare how well two treatments work in postmenopausal women with breast cancer. One treatment group will receive a nonsteroidal aromatase inhibitor plus abemaciclib. The other treatment group will receive a placebo plus abemaciclib.
MONARCH 3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMONARCH 3 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 2018 Phase 2 trial • 132 Patients • NCT02102490MONARCH 3 Trial Design
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Who is running the clinical trial?
Media Library
- I am fully active and can carry on all pre-disease activities without restriction.I haven't taken any unapproved drugs within the last 14 or 21 days, depending on the drug type.I started treatment with bisphosphonates or RANK-L inhibitors less than a week ago.I have received hormone therapy for breast cancer that has returned or spread.I've stopped and recovered from radiotherapy aimed at easing symptoms or preventing bone fractures.I have been treated with or been part of a trial for CDK 4/6 inhibitors.My breast cancer is hormone receptor-positive and HER2-negative.My organs are functioning well.I have inflammatory breast cancer.I have been treated with everolimus before.I have or am receiving chemotherapy for advanced breast cancer.I have or had cancer spread to my brain or spinal cord.My cancer can be measured by tests or is only in my bones.I have not had major surgery in the last 14 days.I can swallow capsules.I have gone through menopause.My cancer has spread to my internal organs, lymph system, or brain/spinal cord linings.I had hormone therapy for cancer and my cancer returned within 12 months after finishing treatment.My cancer has returned or spread and cannot be removed or cured with surgery or radiation.
- Group 1: Abemaciclib + NSAI
- Group 2: Placebo + NSAI
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
What does the research say about Abemaciclib's efficacy?
"Currently, 265 clinical trials are underway that focus on Abemaciclib. Of these ongoing studies, 60 are in Phase 3. The majority of research for this treatment is based in San Francisco, but there are 18164 locations running related studies."
What is the primary way that Abemaciclib helps patients?
"Abemaciclib is most commonly used in conjunction with tamoxifen for a period of 2 to 3 years. Additionally, abemaciclib can be given as standalone treatment for patients with early breast cancer or those at high risk for recurrence."
Are there any unfilled vacancies in this trial for new participants?
"This study does not have any open positions for participants at the moment. The listing was created on November 6th, 2014 and updated most recently on July 21st, 2022. However, there are 2695 other trials concerning breast cancer and 265 studies involving Abemaciclib that are currently recruiting patients."
What are Abemaciclib's known side effects?
"There is both efficacy and safety data available for Abemaciclib because it has progressed to Phase 3 clinical trials. Therefore, our team gives it a score of 3."
How many test subjects are needed for this clinical trial to be effective?
"Unfortunately, this particular study is not currently enrolling patients. Although, it's important to note that this study was most recently edited on 7/21/2022 and 2695 other studies are actively recruiting patients with breast cancer. Additionally, there are 265 trials for Abemaciclib seeking participants."
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