Actively Recruiting
A Phase 2 Trial of Maintenance Abemaciclib and Letrozole After Chemotherapy for Advanced or Recurrent Estrogen Receptor Positive, Mismatch Repair Proficient, TP53 Wild-Type Endometrial Cancer
Led by Dana-Farber Cancer Institute · Updated on 2026-02-11
32
Participants Needed
6
Research Sites
78 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating if the study drugs abemaciclib and letrozole are effective and safe for people with advanced or recurrent estrogen receptor-positive (ER+) endometrial cancer that is mismatch repair proficient and has tumor protein p53 (TP53) wild-type. This phase 2, single arm trial focuses on maintenance treatment following chemotherapy with or without anti-PD-(L)1 blockade. The FDA has not approved these drugs for endometrial cancer but has approved them for other uses. Participants will receive abemaciclib tablets twice daily and letrozole tablets once daily in 21-day cycles. Treatment will continue for up to 2 years. Scans such as X-rays, CT, MRI, or PET will be done every 9 weeks for the first 9 months, then annually. After treatment ends, participants will have assessments and continue follow-up for up to 3 years. The study is supported by Eli Lilly, which provides funding and the abemaciclib drug. During the study, participants will undergo screening and regular evaluations including scans, blood tests, and electrocardiograms (EKGs). Researchers will monitor progression-free survival over 2 years as the primary outcome. Secondary outcomes include adverse event rates, overall survival up to 5 years, and objective response rate. Participants must have good performance status and normal organ function to join and will be followed closely throughout treatment and follow-up periods.
CONDITIONS
Brief Title
ALPINE: Maintenance Letrozole/Abemaciclib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed endometrioid endometrial cancer or endometrial carcinosarcoma with endometrioid component
- Estrogen receptor-positive disease with 61% tumor cell nuclei reactive by immunohistochemistry
- Tumor must be TP53 wild-type by immunohistochemistry or next-generation sequencing
- Mismatch repair proficient endometrial cancer confirmed by immunohistochemistry, PCR, or next-generation sequencing
- No tumor mutational burden 6 10 mutations/megabase
- No known RB1 mutations or two-copy RB1 deletion
- Completed 4 to 10 cycles of carboplatin and taxane chemotherapy or taxane with anti-PD-(L)1 inhibitor therapy
- Measurable stage III, IVA, IVB, or recurrent endometrial cancer
- Prior adjuvant chemotherapy, radiation, or hormonal therapy allowed
- Able to start study drugs 3 to 8 weeks after final chemotherapy or immunotherapy dose
- ECOG performance status 0 to 2
- Age 18 years or older
- Normal organ and bone marrow function within 2 weeks before starting treatment
- Ability to swallow and retain oral medication
- Willingness to release archival tissue if available
- Able to understand and sign informed consent
You will not qualify if you...
- Prior treatment with CDK4/6 inhibitors including abemaciclib
- Gastrointestinal problems interfering with drug absorption or swallowing
- Not recovered from acute effects of chemotherapy except alopecia or mild neuropathy
- Active systemic bacterial, fungal, HIV, or hepatitis B or C infections
- Major surgery or injury within 14 days before starting treatment
- Active brain metastases or unstable brain tumors
- Pregnant or lactating females; women of childbearing potential must use contraception
- Serious uncontrolled medical conditions that may affect participation
- Use of strong CYP3A4 inducers or inhibitors during treatment
- History of cardiovascular conditions such as syncope, ventricular arrhythmia, or sudden cardiac arrest
- Other malignancies within 3 years unless low risk or treated and disease-free for 3 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive maintenance treatment with oral abemaciclib twice daily and letrozole once daily in 21-day cycles following chemotherapy. Imaging scans including X-ray, CT, MRI, or PET are performed regularly to monitor disease status.
Imaging scans every 9 weeks for the first 9 months, then every 12 months
Duration - Up to 3 years
Participants are followed for up to 3 years after completing study treatment to monitor their health and survival.
Visits scheduled periodically during follow-up
Trial Site Locations
Total: 6 locations
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Dana-Farber Cancer Institute at Foxborough
Foxborough, Massachusetts, United States, 02035
Withdrawn
5
Dana-Farber Cancer Institute at Milford
Milford, Massachusetts, United States, 01757
Withdrawn
6
Dana-Farber Cancer Institute at South Shore Hospital
Weymouth, Massachusetts, United States, 02190
Actively Recruiting
Research Team
P
Panagiotis Konstantinopoulos, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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