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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)

Must not have

Impaired cardiovascular function or clinically significant cardiovascular diseases

Known history of drug-induced pneumonitis or other significant symptomatic deterioration of lung functions

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 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.

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.

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 below

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I am fully active and can carry on all my pre-disease activities without restriction.

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My breast cancer is ER+ and HER2-, and cannot be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart problems or significant heart disease.

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I have had lung problems caused by medication before.

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I am not taking any strong drugs or supplements that affect liver enzymes or can cause heart rhythm problems.

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I currently have an active infection.

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I have inflammatory breast cancer.

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

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

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 more

Secondary study objectives

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 more

Awards & 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 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

Ribociclib

2018

Completed Phase 3

~2420

ARV-471

2022

Completed Phase 2

~190