ALPINE: Maintenance Letrozole/Abemaciclib

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)

Trial Details

NCT ID
NCT06366347
Phase
PHASE2
Sponsor
Dana-Farber Cancer Institute
Status
RECRUITING
Cancer Type
Uterine Cancer
Interventions
  • Abemaciclib
  • Letrozole
  • Pembrolizumab
Locations (sample)
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Foxborough, Massachusetts, United States|42.06538,-71.24783

Key Eligibility Criteria

  • Participants must have histologically confirmed either i) endometrioid endometrial cancer or ii) endometrial carcinosarcoma with endometrioid epith…
  • Participants must have ER-positive disease, defined as ≥ 1 percent of tumor cell nuclei being immunoreactive by immunohistochemistry (IHC). If mult…
  • Tumor must be TP53 wild-type as determined by immunohistochemistry (IHC) or via CLIA-certified targeted Next-Generation Sequencing (NGS); IHC asses…
  • Participants must have mismatch repair proficient (MMRP) endometrial cancer as determined by immunohistochemistry (IHC) or polymerase chain reactio…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Uterine Cancer Trials on Trialify →