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Abemaciclib + Fulvestrant for Breast Cancer (MONARCH 2 Trial)
MONARCH 2 Trial Summary
This trial is comparing two treatments for hormone receptor positive, HER2 negative advanced breast cancer. One group will receive abemaciclib + fulvestrant, and the other will just receive fulvestrant. The study will last about 9 months for each participant.
MONARCH 2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMONARCH 2 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 2 Trial Design
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Who is running the clinical trial?
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- I have not taken any experimental drugs recently.I recently got a yellow fever vaccine.I have had heart problems in the last year.I have never received hormone therapy for my current or any previous cancer.I am not pregnant and agree to use birth control during and 12 weeks after the study if my menopause is due to treatment.My cancer can be measured by tests or is only in my bones.My cancer returned or worsened during or after hormone therapy, or I was initially diagnosed with cancer that had already spread.I have not had more than one hormone therapy or any chemotherapy for my advanced cancer.I currently have an active infection (bacterial, fungal, or viral).My breast cancer is HR+ and HER2-, and cannot be cured with surgery.I am postmenopausal due to surgery, natural causes, or medication.I am fully active and can carry on all pre-disease activities without restriction.I have stopped my previous cancer treatments and recovered from their immediate side effects.My cancer has spread to my internal organs, lymph system, or brain/spinal cord linings.My cancer has spread to my brain or spinal cord.I have previously been treated with specific cancer drugs like chemotherapy (not as part of initial treatment), fulvestrant, everolimus, or CDK4/6 inhibitors.I have had a stem-cell transplant.I have not had major surgery recently.I started treatment with bisphosphonates or RANK ligand inhibitors less than a week ago.I have inflammatory breast cancer or have been cancer-free for at least 3 years.
- Group 1: Placebo + Fulvestrant
- Group 2: Abemaciclib + Fulvestrant
- 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 is the largest amount of people that are allowed to enroll in this test?
"This trial is no longer recruiting patients. It was posted on July 22nd, 2014 and last edited on November 15th, 2022. For other trials, there are 2369 studies for breast cancer and 216 for Abemaciclib that are currently admitting patients."
Has Abemaciclib undergone regulatory approval by the FDA?
"Abemaciclib is a safe medication, as there is both efficacy and safety data supporting its use in Phase 3 clinical trials."
What is the standard indication for Abemaciclib?
"The pik3ca gene mutation is most often treated using Abemaciclib. This medication can also be effective at treating other conditions, such as advanced hr+ her2- breast cancer, malignant neoplasms, and disease progression."
Are there any volunteers currently needed for this research project?
"As of right now, this study is not looking for new patients. According to the information on clinicaltrials.gov, which was last updated on November 15th, 2022, the trial was first posted on July 22nd, 2014. If you are interested in other trials, there are currently 2369 active studies related to breast cancer and 216 studies involving Abemaciclib that are actively recruiting participants."
What does the research say about Abemaciclib?
"Abemaciclib was first studied in 2004 at Lowell General Hospital. As of now, a total of 18399 completed studies exist. Currently, there are 216 actively recruiting trials taking place--many of which are based out of Aurora, Colorado."
In how many different areas is this clinical trial taking place?
"There are 55 sites running this trial currently. Some notable locations include Aurora, Winston-Salem and Tulsa. To cut down on how much you may need to travel, it is best to select the clinic nearest you."
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