Fulvestrant + Anastrozole + Abemaciclib for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, CA
Breast Cancer+4 More
Fulvestrant - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a phase 2, open-label, singled-arm clinical trial determining efficacy of combination therapy with anastrozole, fulvestrant and abemaciclib in subjects with breast cancer. These are subjects who are newly diagnosed advanced or metastatic hormone receptor positive breast cancer or subjects who have progressed following treatment free interval of more than 12 months following adjuvant or neoadjuvant treatment.

Eligible Conditions

  • Breast Cancer
  • Hormone Receptor-positive Breast Cancer
  • Metastatic Breast Cancer
  • HER2-negative Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 5 years

Month 3
Objective Response Rate (ORR)
Week 4
The Mean value of changes in circulating tumor cells (CTC)
Up to 5 years
Clinical Benefit Rate
Number of grade 3-5 adverse events
Number of patients who achieved composite outcome
Overall survival
Progression-Free Survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Fulvestrant + Anastrozole + Abemaciclib
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Fulvestrant + Anastrozole + Abemaciclib · No Placebo Group · Phase 2

Fulvestrant + Anastrozole + AbemaciclibExperimental Group · 3 Interventions: Fulvestrant, Anastrozole, Abemaciclib · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3860
Anastrozole
1996
Completed Phase 4
~11230
Abemaciclib
2019
Completed Phase 2
~1700

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Trial Background

Prof. Rita Sanghvi Mehta, Clinical Professor
Principal Investigator
University of California, Irvine
Closest Location: Chao Family Comprehensive Cancer Center, University of California, Irvine · Orange, CA
Photo of Orange  1Photo of Orange  2Photo of Orange  3
2011First Recorded Clinical Trial
1 TrialsResearching Breast Cancer
3 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have had no treatment for advanced or metastatic disease for at least 12 months.
You have at least one measurable disease as defined per RECIST 1.1.
Patients may receive transfusion of packed red blood cells (PRBC) to achieve this hemoglobin level at the discretion of the investigator; however, initial study drug treatment must not begin earlier than the day after the PRBC transfusion.
You have a newly diagnosed metastatic regional or local-regional advanced or recurrent breast cancer.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.