RecruitingPhase 2NCT06366347

ALPINE: Maintenance Letrozole/Abemaciclib

A Phase 2 Trial of Maintenance Abemaciclib/Letrozole After Systemic Therapy in Patients With Advanced or Recurrent Estrogen Receptor Positive, Mismatch Repair Proficient, TP53 Wildtype Endometrial Cancer


Sponsor

Dana-Farber Cancer Institute

Enrollment

32 participants

Start Date

Sep 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research study is to see if the study drugs abemaciclib and letrozole are effective and safe for participants with estrogen-receptor positive (ER+), mismatch repair proficient, tumor protein p53 (TP53) wild-type endometrial cancer. The names of the study drugs involved in this study are: * Abemaciclib (a type of cyclin-dependent kinase (CDK) inhibitor) * Letrozole (a type of aromatase inhibitor)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether letrozole (a hormone therapy) combined with abemaciclib (a targeted drug that slows cell growth) can be used as maintenance therapy to prevent recurrence in people with a specific type of uterine cancer after completing initial treatment. **You may be eligible if...** - You have been diagnosed with endometrioid endometrial cancer or endometrial carcinosarcoma with an endometrioid component - Your tumor tests positive for estrogen receptors (ER-positive) - You have completed initial treatment (such as chemotherapy) with no evidence of disease **You may NOT be eligible if...** - Your cancer has progressed or spread - You have had prior treatment with a CDK4/6 inhibitor or certain hormone therapies for this cancer - You have significant heart, liver, or bone marrow problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbemaciclib

CDK inhibitor, tablet taken orally per protocol.

DRUGLetrozole

Aromatase inhibitor, tablet taken orally per protocol.

DRUGPembrolizumab

Humanized immunoglobulin G4 monoclonal antibody, 4mL (milliliter) single-dose vial, via intravenous (into the vein) infusion per institutional standard of care.


Locations(6)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Dana-Farber Cancer Institute at Foxborough

Foxborough, Massachusetts, United States

Dana-Farber Cancer Institute at Milford

Milford, Massachusetts, United States

Dana-Farber Cancer Institute at South Shore Hospital

Weymouth, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT06366347


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