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Study Summary
This trial is testing abemaciclib as a treatment for triple negative breast cancer. Abemaciclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
- Triple Negative Breast Cancer
- Breast Cancer
- Fibrocystic Breast Disease
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
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 • NCT02102490Awards & Highlights
Trial Design
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Who is running the clinical trial?
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- You have received medication called CDK 4/6 inhibitors, such as palbociclib, ribociclib, abemaciclib, etc. before enrolling in this study.You have had another type of cancer within the past 3 years before signing up for this trial.Carboplatin may be included in the treatment plan.Carboplatin might be included in these treatment plans.You have a history of fainting due to heart problems, abnormal heart rhythms such as ventricular tachycardia or ventricular fibrillation, or sudden cardiac arrest.You can participate in the study if you have breast cancer on one side, but it must be less severe than the cancer being studied. All biopsies and tissue samples will be taken from the more severe cancer.You are willing to have a small amount of tissue removed for research purposes.Carboplatin might be included in the treatment plan.You are currently receiving an experimental treatment for your cancer.It’s okay if you have non-cancerous breast disease, or DCIS or LCIS in the opposite breast.Carboplatin may be included in the treatment plan.You agree to give tissue and blood samples for research purposes.
- Group 1: Cohort A Group 2; Cohort B Group 4 (abemaciclib, surgery)
- Group 2: Cohort A Group 1; Cohort B Group 3 (surgery)
- 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
Is Abemaciclib known to cause any adverse effects in patients?
"Abemaciclib's safety is supported by Phase 2 clinical data, but since there is no efficacy data, it received a score of 2."
Have these findings been seen before?
"Abemaciclib was first studied in 2009 in an Eli Lilly and Company-sponsored clinical trial. After the first Phase 1 study involving 220 people, the drug received approval. 96 studies are currently ongoing in 1273 cities and 41 countries."
What does Abemaciclib help patients with the most?
"Abemaciclib is most commonly used as an intervention for high risk of recurrence. It can also be used to treat multiple other conditions, like advanced hormone receptor positive, human epidermal growth factor negative breast cancer, endocrine therapy, and breast."
What other scientific literature is there on Abemaciclib?
"Abemaciclib was first studied in 2009. If you would like more information about where this clinical trial is taking place, you can call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday through Friday from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. 63 studies have completed since the original research was conducted and 96 are currently ongoing, a large portion of which are based in Scottsdale, Arizona."
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