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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1b: number of participants with dose limiting toxicities
Phase 2: percentage of participants with objective response by investigator assessment
Secondary outcome measures
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 moreTrial 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
Abemaciclib
2019
Completed Phase 2
~1710
ARV-471
2022
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,986 Total Patients Enrolled
111 Trials studying Breast Cancer
36,404 Patients Enrolled for Breast Cancer
Arvinas Estrogen Receptor, Inc.Industry Sponsor
17 Previous Clinical Trials
2,329 Total Patients Enrolled
7 Trials studying Breast Cancer
1,615 Patients Enrolled for Breast Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,092,181 Total Patients Enrolled
42 Trials studying Breast Cancer
12,768 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any slots open for new participants in this clinical trial?
"According to clinicaltrials.gov, this trial is presently recruiting participants. It was originally posted on February 17th 2023 and the most recent update happened on February 5th 2023."
Answered by AI
How many sites are responsible for the oversight of this research project?
"This ongoing research is recruiting participants from a total of 9 different sites, with the most localised locations being in Creve Coeur, Florissant and Saint Louis. To reduce travel commitments, it may be beneficial to select the medical centre closest to you if you choose to join this trial."
Answered by AI
To what extent is the research team recruiting participants for this investigation?
"Affirmative, the information found on clinicaltrials.gov reveals that this medical trial is actively recruiting for 35 individuals across 9 different sites. This research project was initially posted on February 17th 2023 and has since been updated on February 5th 2023."
Answered by AI
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