Actively Recruiting
ALPINE: Maintenance Letrozole/Abemaciclib
Led by Dana-Farber Cancer Institute · Updated on 2026-02-11
32
Participants Needed
6
Research Sites
231 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
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)
CONDITIONS
Official 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 epithelial component
- Estrogen receptor (ER) positive disease with at least 1% tumor cell nuclei immunoreactive by immunohistochemistry
- Tumor is TP53 wild-type determined by immunohistochemistry or targeted next-generation sequencing
- Mismatch repair proficient endometrial cancer confirmed by immunohistochemistry, PCR, or CLIA-certified sequencing
- No tumor mutational burden of 10 mutations/megabase or higher
- No known RB1 mutations or two-copy RB1 deletion
- Completed 4 to 10 cycles of carboplatin and taxane chemotherapy or taxane plus anti-PD-(L)1 therapy
- Have measurable stage III, IVA, IVB, or recurrent endometrial cancer
- Prior adjuvant chemotherapy or radiation therapy completed at least 4 weeks before registration
- Able to start study drugs 3 to 8 weeks after finishing chemotherapy and anti-PD-(L)1 therapy
- ECOG performance status of 0 to 2
- Age 18 years or older
- Normal organ and bone marrow function within 2 weeks before starting treatment
- Able to understand and sign informed consent
- Able to swallow and retain oral medication
- Willing to release archival tissue if available
You will not qualify if you...
- Previous treatment with CDK4/6 inhibitors including abemaciclib
- Gastrointestinal problems interfering with drug absorption such as bowel obstruction or severe nausea/vomiting
- Not recovered from acute chemotherapy effects except residual hair loss or mild peripheral neuropathy
- Active systemic bacterial, fungal, or viral infections including HIV or active hepatitis B or C
- Major surgery or injury within 14 days before starting treatment or planned major surgery during study
- Radiation therapy not completed or acute effects not fully recovered with less than 14 days washout
- Other malignant diseases within 3 years except certain low-risk cancers
- Active brain metastases requiring treatment or symptomatic
- Pregnant or lactating females; women of childbearing potential must use contraception during treatment and 3 months after
- Serious uncontrolled medical conditions such as severe lung disease, severe kidney impairment, or inflammatory bowel disease
- Need for strong CYP3A4 inducers or inhibitors during treatment without substitution
- History of serious cardiac conditions such as syncope, ventricular arrhythmia, or sudden cardiac arrest
- History of other malignancies unless disease-free for at least 3 years or deemed low risk by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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