ALPINE: Maintenance Letrozole/Abemaciclib

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06366347
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib — DRUG
    CDK inhibitor, tablet taken orally per protocol.
  • Letrozole — DRUG
    Aromatase inhibitor, tablet taken orally per protocol.
  • Pembrolizumab — DRUG
    Humanized immunoglobulin G4 monoclonal antibody, 4mL (milliliter) single-dose vial, via intravenous (into the vein) infusion per institutional standard of care.

Study Details

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)

Key Dates

Start date
Sep 25, 2024
Status verified
Aug 2025
Primary completion
Sep 1, 2027
Completion
Mar 1, 2029

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Abemaciclib + Letrozole
    Participants will be stratified by Primary Stage IVb (4b) vs. Primary Measurable Stage III (3)/IVa (4a) vs. Recurrent Endometrial Cancer and will complete study procedures as follows: * Baseline visit with X-ray, CT, MRI, or PET scan. * Cycles 1 through 3: --Days 1 through 21 of 21 day cycle: Predetermined dose of Abemaciclib 2x per day. Predetermined dose of Letrozole 1x per day. * Cycle 4 and every 2 cycles thereafter: --Days 1 through 21 of 21 day cycle: Predetermined dose of Abemaciclib 2x per day. Predetermined dose of Letrozole 1x per day. * X-ray, CT, MRI, or PET scan every 9 weeks for first 9 months, then every 12 months. * End of Treatment visit with assessments and X-ray, CT, MRI, or PET scan. * Follow up for up to 3 years.

Primary Outcome Measure

Median Progression Free Survival (PFS) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Meghan Shea, MD
[email protected]
617-667-3723
Meghan Shea, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02215
Panagiotis Konstantinopoulos, MD, PhD
[email protected]
617-632-2334
Panagiotis Konstantinopoulos, MD, PhD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Panagiotis Konstantinopoulos, MD, PhD
[email protected]
617-632-2334
Panagiotis Konstantinopoulos, MD, PhD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer Institute at FoxboroughFoxboroughMassachusetts02035-
Dana-Farber Cancer Institute at MilfordMilfordMassachusetts01757-
Dana-Farber Cancer Institute at South Shore HospitalWeymouthMassachusetts02190
Meredith Faggen, MD
[email protected]
781-624-4800
Meredith Faggen, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Beth Israel Deaconess Medical Center· Boston, MABrigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MADana-Farber Cancer Institute at Foxborough· Foxborough, MADana-Farber Cancer Institute at Milford· Milford, MADana-Farber Cancer Institute at South Shore Hospital· Weymouth, MA

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