Your session is about to expire
← Back to Search
Cyclin-Dependent Kinase Inhibitor
Combination Therapy for Advanced Breast Cancer
Phase 2
Recruiting
Led By Rita Mehta, MD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Post-menopausal status as defined by specific criteria
Patients must have a diagnosis of HR+ breast cancer with at least one hormone receptor (ER, PgR) expression by immunohistochemistry (IHC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new combination therapy for breast cancer that has progressed following treatment or for newly diagnosed advanced or metastatic hormone receptor positive breast cancer.
Who is the study for?
This trial is for post-menopausal women with HR+HER2- advanced or metastatic breast cancer, who have relapsed more than a year after prior treatments. Participants must be over 18, in good health with proper organ function, and not currently pregnant. They should agree to contraception if of child-bearing potential.Check my eligibility
What is being tested?
The study tests a combination therapy using Anastrazole, Fulvestrant & Abemaciclib on patients newly diagnosed with advanced breast cancer or those whose cancer returned after treatment-free interval of over 12 months.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, diarrhea, low blood cell counts leading to increased infection risk, liver problems, blood clots and potential harm to an unborn baby if the patient becomes pregnant during treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am post-menopausal.
Select...
My breast cancer is hormone receptor positive.
Select...
I am 18 years old or older.
Select...
I am able to get out of my bed or chair and move around.
Select...
My breast cancer is newly diagnosed as stage IV or is advanced and cannot be cured.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Clinical Benefit Rate
Number of grade 3-5 adverse events
Number of patients who achieved composite outcome
+2 moreSide effects data
From 2018 Phase 4 trial • 79 Patients • NCT0213753810%
Fracture
8%
Acne
5%
Scoliosis
3%
Hair loss
3%
Sacroiliitis
3%
Neuro event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anastrozole
Letrozole
Trial Design
1Treatment groups
Experimental Treatment
Group I: Fulvestrant + Anastrozole + AbemaciclibExperimental Treatment3 Interventions
Fulvestrant, intramuscular, Initial: 500 mg on days 1 and 15; Maintenance: 500 mg once monthly.
Anastrozole, oral, 1mg tablet daily
Abemaciclib 150 mg twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3690
Anastrozole
2019
Completed Phase 4
~10300
Abemaciclib
2019
Completed Phase 2
~1710
Find a Location
Who is running the clinical trial?
University of California, IrvineLead Sponsor
544 Previous Clinical Trials
1,923,023 Total Patients Enrolled
12 Trials studying Breast Cancer
2,100 Patients Enrolled for Breast Cancer
Rita Mehta, MDPrincipal InvestigatorChao Family Comprehensive Cancer Center
4 Previous Clinical Trials
210 Total Patients Enrolled
1 Trials studying Breast Cancer
48 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is HER2 positive or triple negative.I have been diagnosed with inflammatory breast cancer.I have had chemotherapy or radiotherapy within the last year.You have had certain medical conditions in the past.My cancer returned more than a year after completing initial treatment, with no treatment for advanced stages.I have been treated with Fulvestrant before.I am post-menopausal.My organs and bone marrow are working well.My cancer has spread to organs like the liver or brain.My breast cancer can be treated with surgery or radiation.I do not have any active infections.I have recently been treated with a biological or monoclonal therapy.My breast cancer is hormone receptor positive.I am 18 years old or older.I am able to get out of my bed or chair and move around.I agree to use birth control methods during the study.I am a woman who could potentially become pregnant.I have been cancer-free for at least 3 years or had a stem-cell transplant.You have at least one detectable and measurable disease according to specific medical guidelines.I had chemotherapy over a year ago to shrink my tumor before surgery.I am allergic to certain cancer medications similar to CDK4/6 inhibitors.My breast cancer is newly diagnosed as stage IV or is advanced and cannot be cured.
Research Study Groups:
This trial has the following groups:- Group 1: Fulvestrant + Anastrozole + Abemaciclib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Anastrozole secured authorization from the FDA?
"Through our analysis, we have determined that Anastrozole is moderately safe and scored it a 2. This assessment was based on the fact this trial is in Phase 2, signifying some safety data but no efficacy information has been gathered yet."
Answered by AI
How many participants are engaging in this experiment?
"Affirmative. Details on clinicaltrials.gov illustrate that the medical trial is currently recruiting, with its initial post from August 31st 2022 and last update occurring October 26th 2022. The research requires 20 participants to be recruited across a single location."
Answered by AI
Is it possible to enroll in this clinical study at the moment?
"Affirmative, the information hosted on clinicaltrials.gov indicates that this medical study is currently enrolling volunteers. The first posting was done on August 31st 2022 and it has been refreshed as recently as October 26th of the same year. A total of 20 patients need to be recruited from a single clinic."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger