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Fulvestrant + Abemaciclib for Breast Cancer
Study Summary
This trial will explore if taking a one-month break from CDK4/6 inhibitor drug, abemaciclib, will make the body more sensitive to the drug and improve its effectiveness when used with fulvestrant.
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 2016 Phase 2 & 3 trial • 12 Patients • NCT02116803Trial Design
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Who is running the clinical trial?
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- My blood, liver, and kidney functions are all within normal ranges.You are allergic to certain medications or their ingredients.I have a bleeding disorder or am currently using blood thinners.I am using corticosteroids for brain metastases.I do not have any active infections.You currently have hepatitis B or C infection that is not under control.I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks.You have had specific heart or blood vessel problems in the past.My cancer can be measured by scans or is only in my bones.My cancer has spread to my brain, meeting specific study criteria.I have recovered from the immediate side effects of my cancer treatments.My breast cancer is ER-positive and HER2-negative.I can swallow pills.I have symptoms of not absorbing nutrients well.I am not taking strong drugs that affect liver enzymes.I have not received a live vaccine recently.I don't have any health issues that could affect the trial's results.I am fully active or can carry out light work.I have another cancer that is growing or needs treatment.You have reached menopause or are receiving a specific treatment that stops your ovaries from working.My cancer progressed after treatment with a CDK4/6 inhibitor and an AI.I do not have serious or uncontrolled health conditions.You are expected to live for at least 6 more months.I have had heart problems in the last year.I am a woman over 18 and have signed the consent form.Women must have a negative pregnancy test within 7 days before starting the trial treatment.
- Group 1: Fulvestrant plus Abemaciclib Arm with Fulvestrant Run-In
- 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 enrollment still open for this research project?
"Affirmative, according to the clinicaltrials.gov website this medical experiment is in need of participants. It was first published on February 25th 2021 and most recently updated on March 23rd 2022. About 56 people are required from 1 research facility for completion of the trial."
Have any regulatory bodies given the green light to Fulvestrant Run-In?
"Our team at Power has assigned Fulvestrant Run-In a score of 2, as it is only backed by limited safety data and no efficacy evidence."
To what extent is this trial populated by participants?
"Affirmative, according to the information found on clinicaltrials.gov this trial is actively searching for participants. It was first posted in February 2021 and most recently updated in March 2022; 56 patients are needed from one medical centre."
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