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Abemaciclib for Triple Negative Breast Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may 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 • NCT02102490Trial Design
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Who is running the clinical trial?
Media Library
- I have had a breast biopsy for this cancer.I still have signs of cancer in my breast after chemotherapy.I have not had any other cancer within the last 3 years.I have had a blood clot in my veins or lungs within the last year or I am currently on blood thinners for a clot.I am a woman aged 18 or older.My breast cancer is in stages 1-4, may have spread to nearby lymph nodes, but not to distant parts of the body.I can take pills by mouth.I have more than one breast cancer, with the largest being triple-negative and resistant to chemotherapy.My breast cancer is confirmed to be triple negative.Women who can have babies must have a negative pregnancy test within 7 days before joining the study.I do not have serious health issues that would stop me from joining this study.I am not currently on any experimental drugs for my cancer.I am willing to stop taking certain medications that affect my liver enzymes 7 days before joining.I have no medical reasons preventing me from getting a biopsy before joining.I registered for the trial within 56 days after my last chemotherapy before surgery.I have been treated with CDK 4/6 inhibitors before.I do not have any known infections.I am currently not on chemotherapy, radiotherapy, immunotherapy, or similar treatments.I am willing to have a biopsy for research purposes.My breast cancer is confirmed to be at stage IV.I haven't taken strong medication affecting liver enzymes in the last week.I still have side effects from earlier chemotherapy that are not mild.I have had radiation treatment for my breast cancer.I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.Your lab test results need to be within certain ranges for Cohort B GROUP 4.I have had non-invasive breast conditions or cancer.I am receiving specific chemotherapy drugs with pembrolizumab before surgery.I am receiving specific chemotherapy before surgery.I can take care of myself but might not be able to do heavy physical work.
- Group 1: Cohort A Group 1; Cohort B Group 3 (surgery)
- Group 2: Cohort A Group 2; Cohort B Group 4 (abemaciclib, 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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