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CDK4/6 Inhibitor

CDK4/6 Inhibitors for Metastatic Breast Cancer

Boston, MA

Phase 3

Recruiting

Led By Julie Gralow, MD

Research Sponsored by American Society of Clinical Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have histologically confirmed hormone receptor positive (HR+) HER2 negative metastatic breast cancer. Cut-off values for positive/negative staining should be as per standard practice in accordance with ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines.

Creatinine < institutional ULN or creatinine clearance > 30 mL/min/1.73 m2 for subjects with creatinine levels above institutional ULN.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

"This trial aims to find a better dosing strategy for CDK4/6 inhibitors in older patients with Metastatic Breast Cancer to help them tolerate side effects and stay on treatment longer. The study

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Who is the study for?

This trial is for people aged 65 or older with a specific type of advanced breast cancer (HR+ HER2- metastatic). They must have normal liver and kidney function, adequate blood cell counts, and be starting CDK4/6 inhibitor therapy with endocrine therapy for the first time.Check my eligibility

What is being tested?

The study tests different dosing strategies of two drugs, Ribociclib and Palbociclib, used in treating advanced breast cancer. Patients will either receive the standard dose or start at a lower dose that increases if tolerated well, alongside chosen endocrine therapy.See study design

What are the potential side effects?

Common side effects may include low white blood cell count which can lead to infection risk, fatigue, nausea, hair thinning or loss, mouth sores. Side effects vary based on individual tolerance to treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is hormone receptor positive and HER2 negative.

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My kidney function is within the normal range or slightly above but still acceptable.

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I am 65 years old or older.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to Treatment Discontinuation (TTD)

Secondary study objectives

Body Mass Index

Event-Free survival (EFS)

Healthcare utilization (ED visits, hospital admissions, etc.)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2: Titrated DoseExperimental Treatment2 Interventions

Arm 2 is the titrated dosing regimen: participants will start cycle 1 with either 100 mg or 75 mg dose of palbociclib or 400 mg or 200 mg dose of ribociclib, in combination with endocrine therapy (AI or fulvestrant). For cycle 2 and for subsequent cycles, escalation to the indicated dose will be based on treatment tolerance.

Group II: Arm 1: Indicated DoseExperimental Treatment4 Interventions

Arm 1 of the study is the indicated dosing regimen, provided in the FDA approved drug label: participants will start cycle 1 with either 125mg dose of palbociclib or 600mg dose of ribociclib, in combination with endocrine therapy (AI or fulvestrant).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ribociclib

2018

Completed Phase 3

~3090

Palbociclib

2017

Completed Phase 3

~3910