OncoMatch/Clinical Trials/NCT06366347
ALPINE: Maintenance Letrozole/Abemaciclib
Is NCT06366347 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Abemaciclib and Letrozole for endometrial cancer.
Treatment: Abemaciclib · Letrozole · Pembrolizumab — 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)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Endocrine / hormonal
Cancer type
Endometrial Cancer
Biomarker criteria
Required: ESR1 overexpression (≥ 1 percent of tumor cell nuclei immunoreactive by IHC)
Participants must have ER-positive disease, defined as ≥ 1 percent of tumor cell nuclei being immunoreactive by immunohistochemistry (IHC)
Required: TP53 wild-type
Tumor must be TP53 wild-type as determined by immunohistochemistry (IHC) or via CLIA-certified targeted Next-Generation Sequencing (NGS)
Excluded: RB1 mutation
No known RB1 mutations
Excluded: RB1 two-copy deletion
No known...two-copy RB1 deletion
Disease stage
Required: Stage III, IVA, IVB
measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy (carboplatin) — combination with taxane or with taxane and anti-PD-(L)1 inhibitor
Participants must have just completed a minimum of 4 cycles and a maximum of 10 cycles of a combination of carboplatin and taxane or a combination of taxane and anti-PD-(L)1 inhibitor therapy
Must have received: taxane — combination with carboplatin or with anti-PD-(L)1 inhibitor
Participants must have just completed a minimum of 4 cycles and a maximum of 10 cycles of a combination of carboplatin and taxane or a combination of taxane and anti-PD-(L)1 inhibitor therapy
Cannot have received: CDK4/6 inhibitor (abemaciclib)
Participants who have received previous treatment with CDK4/6 inhibitors, including but not limited to previous abemaciclib therapy
Lab requirements
Blood counts
ANC ≥1.5 × 10^9 /L; Platelets ≥100 × 10^9 /L; Hemoglobin ≥8 g/dL (transfusions allowed)
Kidney function
Creatinine ≤ 1.5 × institutional ULN, OR Creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels above 1.5 x institutional ULN
Liver function
Total bilirubin ≤1.5 × ULN (≤2.0 × ULN with Gilbert's syndrome and direct bilirubin within normal limits); ALT and AST ≤3 × ULN
Participants must have normal organ and bone marrow function within 2 weeks before starting protocol therapy as defined below: Hematologic: ANC ≥1.5 × 10^9 /L; Platelets ≥100 × 10^9 /L; Hemoglobin ≥8 g/dL... Hepatic: Total bilirubin ≤1.5 × ULN... ALT and AST ≤3 × ULN... Renal: Creatinine ≤ 1.5 × institutional ULN, OR Creatinine clearance ≥ 60 mL/min/1.73 m2...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Beth Israel Deaconess Medical Center · Boston, Massachusetts
- Brigham and Women's Hospital · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
- Dana-Farber Cancer Institute at Foxborough · Foxborough, Massachusetts
- Dana-Farber Cancer Institute at Milford · Milford, Massachusetts
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06366347 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CDK4/6 inhibitor disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 overexpression is a required biomarker for enrollment.
Does this trial require TP53?
Yes, TP53 wild-type is a required biomarker for enrollment.
Are patients with RB1 alterations eligible?
No. RB1 mutation is an exclusion criterion.
Are patients with RB1 alterations eligible?
No. RB1 two-copy deletion is an exclusion criterion.
What disease stage is eligible?
Stage III or IVA or IVB is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages