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Abemaciclib + Elacestrant for Breast Cancer with Brain Metastasis
Study Summary
This trial is testing a new cancer drug combo on patients with HR+/Her2- breast cancer that has spread to the brain.
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?
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- I have not had any cancer other than skin or early cervical cancer in the last 5 years.I am a woman and have not gone through menopause.My organs are functioning well.I am post-menopausal based on age, surgery, or hormone levels.I can take pills by mouth.I have no conditions that prevent me from taking pills.I have samples of my tumor available for testing.I am a post-menopausal woman with a specific type of breast cancer that is positive for hormone receptors and negative for HER2.I've had up to 2 chemotherapy treatments for my cancer and it's been 2 weeks since my last cancer treatment.I have fully recovered from any side effects of my previous radiotherapy.I currently have an active infection (bacterial, fungal, or viral).I am not pregnant, breastfeeding, or a man.I am under 18 years old.I do not have any serious uncontrolled medical or mental health conditions.I have previously used abemaciclib or elacestrant.I have recovered from chemotherapy side effects, except for possible hair loss or mild nerve damage.I have had more than two seizures in the past month.I can take care of myself but might not be able to do heavy physical work.My brain cancer has grown despite previous treatments.I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.I am using effective birth control methods.
- Group 1: Abemaciclib/Elacestrant
- 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
What is the maximum capacity for enrollees in this research project?
"As mandated by the inclusion criteria, 44 participants are necessary to facilitate this trial. The sponsor organization, Criterium Inc., is running it from local hospitals such as Duke Cancer Center in Durham (NC) and Cancer Care Northwest situated in Spokane Valley (WA)."
Is this an experimental clinical trial?
"Presently, 93 separate clinical trials related to Abemaciclib are being conducted in 1309 cities and 42 nations. Back in 2009, Eli Lilly and Company first initiated a Phase 1 trial with 220 participants - since then 35 further studies have been completed."
What maladies is Abemaciclib commonly prescribed for?
"Abemaciclib is suitable for treating a range of severe breast cancer cases, from those with an elevated risk of relapse to patients whose tumours are both HR+ and HER2-. Additionally, it can be used as part of endocrine therapy."
Are there any prior experiments involving Abemaciclib that have been performed?
"Abemaciclib was originally studied in 2009 and has since been included in 35 completed clinical trials. At present, 93 active studies are ongoing with many of these conducted at Durham, North carolina's medical centres. For more information about potential enrolment sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559) during business hours Eastern Standard Time (UTC/GMT - 5 hours)."
Is there open enrollment for the current trial?
"Affirmative, clinicaltrials.gov has information indicating that recruitment is currently underway for this trial which was first published on April 21st 2022. As of May 10th 2022, the study still needs 44 volunteers at 3 medical centres."
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