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Abemaciclib + Endocrine Therapy for Breast Cancer (monarchE Trial)
monarchE Trial Summary
This trial is testing a new drug to see if it can effectively treat early stage breast cancer that is hormone receptor positive and human epidermal receptor 2 negative.
monarchE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowmonarchE 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 • NCT02102490monarchE Trial Design
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Who is running the clinical trial?
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- I can take pills by mouth.My cancer has spread to distant areas or is present without lymph node involvement.I have mostly recovered from the side effects of my cancer treatments and surgery.I am fully active and can carry on all pre-disease activities without restriction.I am currently on hormone therapy for reproductive reasons.My cancer is aggressive, scoring 8 or more on a specific scale.I had breast cancer or other cancers, but have been in remission for over 5 years, except for skin cancer or cervical carcinoma in situ.My breast cancer has spread to lymph nodes and shows high risk of coming back due to its size, grade, or growth rate.I had my breast cancer surgery less than 16 months ago.I do not have any active infections or high viral loads.I am a man or woman aged 18 or older.I can have hormone therapy for up to 12 weeks after my last cancer treatment.My organs are working well.I have had surgery to remove my breast cancer.My breast cancer is HR positive, HER2 negative, early stage, and has not spread far.I can provide tumor tissue from my breast or lymph node for testing before being assigned to a treatment group.My tumor is at least 5 cm in size.I have been treated with CDK4/6 inhibitors before.I have taken medication (like tamoxifen) for breast cancer prevention.I have inflammatory breast cancer.I may have hormone therapy for up to 12 weeks after my last cancer treatment.I am a man or woman aged 18 or older.I have a history of fainting due to heart issues, abnormal heart rhythms, or sudden cardiac arrest. I also have a history of blood clots in my veins.I am not pregnant or breastfeeding.
- Group 1: 150 mg Abemaciclib + Endocrine Therapy
- Group 2: Endocrine Therapy
- 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
Have any other clinical trials been done like this one before?
"Abemaciclib has undergone extensive scrutiny since its inception in 2009. The first study, sponsored by Eli Lilly, included 220 participants. After the first study's successful completion, Abemaciclib received Phase 1 drug approval. As of now, 96 active studies are being conducted in 1273 cities and 41 countries."
Did the Federal Drug Administration greenlight Abemaciclib for public use?
"Abemaciclib's safety rating is a 3. This is based on the fact that it is a Phase 3 trial, and thus there is both efficacy and safety data available."
Are there other research studies that have used Abemaciclib?
"Abemaciclib was first researched in 2009. If you wish to learn more about the locations of these clinical trials, you can call the number provided or speak to your personal doctor. There have been a total of 30 completed studies, with 96 more presently ongoing. Some of these trials are based in Springfield, Virginia."
In how many different locations is this research being conducted today?
"100 patients are being recruited from medical facilities across the country, such as the Willamette Valley Cancer Institute & research Ctr. in Springfield, Hematology Oncology Associates of Fredericksburg Inc. in Fredericksburg, and Virginia Oncology Associates in Norfolk."
For what type of ailment is Abemaciclib most often recommended by doctors?
"Abemaciclib is typically used to lower the risk of cancer recurrence. However, it can also be used to treat advanced hr + her2 - breast cancer, endocrine therapy, and breast cancer."
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