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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
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to approximately 3 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to approximately 3 year
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~190
Abemaciclib
2019
Completed Phase 2
~1890
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,658 Previous Clinical Trials
17,877,385 Total Patients Enrolled
113 Trials studying Breast Cancer
41,306 Patients Enrolled for Breast Cancer
Arvinas Estrogen Receptor, Inc.Industry Sponsor
18 Previous Clinical Trials
2,346 Total Patients Enrolled
7 Trials studying Breast Cancer
1,617 Patients Enrolled for Breast Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,544 Previous Clinical Trials
14,918,561 Total Patients Enrolled
45 Trials studying Breast Cancer
17,714 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had lung problems caused by medication before.My condition is inflammatory breast cancer.My kidney, liver, or bone marrow is not working properly.I currently have an active infection.I am fully active and can carry on all pre-disease activities without restriction.I have heart problems or significant heart disease.My breast cancer is ER+ and HER2-, and cannot be removed by surgery.I am not taking any strong drugs or supplements that affect liver enzymes or can cause heart rhythm problems.I haven't had any cancer except for certain skin cancers or treated cervical cancer in the last 3 years.I have brain metastases but am stable and off certain medications for 14 days.I've had 1-2 treatments for advanced cancer, including a CDK4/6 inhibitor.
Research Study Groups:
This trial has the following groups:- Group 1: ARV-471 in combination with 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.
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