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Hormone Therapy
ARV-471 + Ribociclib 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
ECOG PS ≤1
Histological or cytological diagnosis of ER+ and HER2- advanced/metastatic breast cancer that is not amenable to surgical resection with curative intent (≥1% ER+ stained cells on the most recent tumor biopsy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to approximately 3 year
Awards & highlights
Study Summary
This trial looks at a medicine (ARV-471) & another (ribociclib) to see if they're safe & effective for advanced or metastatic breast cancer that's not responding to previous treatment. Participants take meds at home & visit clinic every 4 weeks.
Who is the study for?
This trial is for people with advanced or metastatic breast cancer that's hormone-sensitive and not responding to previous treatments. Participants must have at least one measurable tumor, received up to two prior therapies, and had a CDK4/6 inhibitor regimen. They should be relatively healthy (ECOG PS ≤1) without serious heart issues, other recent cancers (except certain skin cancers or treated cervical carcinoma), active infections, renal or liver problems, brain metastases unless stable and untreated for 14 days.Check my eligibility
What is being tested?
The study tests ARV-471 combined with Ribociclib in patients with estrogen receptor-positive breast cancer that has spread and can't be removed by surgery. Both drugs are taken orally once daily at home. The trial aims to assess the safety and effectiveness of this combination therapy as long as it continues to work without intolerable side effects.See study design
What are the potential side effects?
Potential side effects include those common to cancer medications such as nausea, fatigue, blood count changes leading to increased infection risk or bleeding tendencies, possible liver function alterations, potential heart rhythm disturbances due to QT interval prolongation risks associated with Ribociclib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
My breast cancer is ER+ and HER2-, and cannot be removed by surgery.
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
Drug Drug Interaction cohort: Area Under the Curve from Time Zero to end of dosing interval Evaluation of ribociclib with and without co-administration of ARV-471
Drug Drug Interaction cohort: Maximum Plasma Concentration (Cmax) of ribociclib with and without co-administration of ARV-471
Phase 1b: Number of Participants With Dose Limiting Toxicities
+1 moreSecondary outcome measures
Drug Drug Interaction cohort: number of participants with changes from baseline for ECG parameters
Phase 1b Area Under the Curve from Time Zero to end of dosing interval Evaluation of ARV-471 with and without co-administration of ribociclib
Phase 1b and Phase 2: Duration of Response by investigator assessment.
+12 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ARV-471 in combination with RibociclibExperimental Treatment2 Interventions
ARV-471 administered orally QD continuously and Ribociclib administered orally QD consecutively for 21 days followed by 7 days off treatment on 28-day cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARV-471
2022
Completed Phase 1
~50
Ribociclib
2018
Completed Phase 3
~2330
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,939 Total Patients Enrolled
111 Trials studying Breast Cancer
36,397 Patients Enrolled for Breast Cancer
Arvinas Estrogen Receptor, Inc.Industry Sponsor
17 Previous Clinical Trials
2,322 Total Patients Enrolled
7 Trials studying Breast Cancer
1,608 Patients Enrolled for Breast Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,092,134 Total Patients Enrolled
42 Trials studying Breast Cancer
12,761 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart problems or significant heart disease.I am fully active and can carry on all my pre-disease activities without restriction.I have had lung problems caused by medication before.You have at least one visible and measurable abnormality according to specific criteria.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 2 weeks.I am not taking any strong drugs or supplements that affect liver enzymes or can cause heart rhythm problems.I have kidney, liver, or bone marrow problems.I currently have an active infection.You have a serious condition in your internal organs that could be life-threatening in the near future.I've had up to 2 treatments for advanced cancer, including one with CDK4/6 inhibitors.I have inflammatory breast cancer.My breast cancer is ER+ and HER2-, and cannot be removed by surgery.
Research Study Groups:
This trial has the following groups:- Group 1: ARV-471 in combination with Ribociclib
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.
How does the combination of ARV-471 and Ribociclib affect patient safety?
"While there is evidence supporting the safety of ARV-471 combined with Ribociclib, no efficacy data regarding this combination exists yet. Thus, it received a score of 2."
Answered by AI
Are participants still being welcomed to join this medical trial?
"Clinicaltrials.gov states that this trial is not actively recruiting participants. First published on February 10th 2023, and last updated on the 1st of February in the same year, it looks to be inactive for now. However, there are currently 2528 other trials accepting volunteers right now."
Answered by AI
In what number of health facilities is this exploration in progress?
"At this current time, there are 9 trial clinics across various cities including Creve Coeur, Florissant and Saint Louis. It is essential to select the closest one available in order to mitigate any travelling requirements should you choose to partake."
Answered by AI
What is the central aim of this trial?
"This clinical trial is assessing the number of participants with dose-limiting toxicities as its primary outcome within an approximated 1 year time frame. To gain further insight, investigators are also evaluating the percentage of patients who respond positively to treatment (CBR), changes in plasma ctDNA levels pre and post administration, and how ribociclib impacts ARV-471 pharmacokinetics (AUCtau and Cmax)."
Answered by AI
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