← Back to Search

CDK4/6 Inhibitor

ARV-471 + Abemaciclib for Advanced Breast Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to approximately 3 year
Awards & highlights

Summary

This trial studies the safety/effects of a medicine for advanced/metastatic breast cancer. Participants take meds at home, visit clinic every 4 wks.

Who is the study for?
This trial is for individuals with advanced or metastatic breast cancer that's estrogen receptor positive and not responding to previous treatments. Participants must have had up to two prior therapies, including one CDK4/6 inhibitor regimen, and should be in a stable condition without life-threatening visceral complications or recent other cancers.
What is being tested?
The study tests ARV-471 combined with abemaciclib in people with certain types of breast cancer. Both medications are taken orally at home—ARV-471 once daily and abemaciclib twice daily—and the effects on patients' health will be monitored regularly at the clinic.
What are the potential side effects?
Potential side effects may include reactions typical of cancer medications such as nausea, fatigue, blood count changes, liver function alterations, potential lung issues like pneumonitis, and possibly heart-related side effects due to drug interactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to approximately 3 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to approximately 3 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1b: number of participants with dose limiting toxicities
Phase 2: percentage of participants with objective response by investigator assessment
Secondary study objectives
Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of ARV-471
Phase 1b and Phase 2: Maximum Observed Plasma Concentration (Cmax) of abemaciclib
Phase 1b and Phase 2: Progression Free Survival by investigator assessment.
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ARV-471 in combination with AbemaciclibExperimental Treatment2 Interventions
ARV-471 administered orally once daily (QD) and Abemaciclib orally twice daily (BID) on 28-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARV-471
2022
Completed Phase 2
~200
Abemaciclib
2019
Completed Phase 2
~1800

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,625 Previous Clinical Trials
14,284,154 Total Patients Enrolled
114 Trials studying Breast Cancer
41,431 Patients Enrolled for Breast Cancer
Arvinas Estrogen Receptor, Inc.Industry Sponsor
17 Previous Clinical Trials
2,334 Total Patients Enrolled
7 Trials studying Breast Cancer
1,617 Patients Enrolled for Breast Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,518 Previous Clinical Trials
11,458,730 Total Patients Enrolled
45 Trials studying Breast Cancer
17,762 Patients Enrolled for Breast Cancer

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05548127 — Phase 1 & 2
Breast Cancer Research Study Groups: ARV-471 in combination with Abemaciclib
Breast Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT05548127 — Phase 1 & 2
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05548127 — Phase 1 & 2
~18 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top