NCT04049227

Abemaciclib and Letrozole in Treating Patients With Endometrial Cancer

A Pilot, Multicenter, Single Arm, Open Label, Surgical Window of Opportunity Study of Abemaciclib and Letrozole for Endometrioid Adenocarcinoma of the Endometrium

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This early phase I trial studies how well abemaciclib and letrozole work in treating patients with endometrial cancer and determines whether there are changes in patients' cancer cell biomarkers (a genetic feature or specific protein) for cell growth before and after treatment. Antihormone therapy with aromatase inhibitors, such as letrozole, may lessen the amount of estrogen made by the body. Abemaciclib blocks the activities of a class of proteins called cyclin-dependent kinase, which are involved in cell duplication. Giving letrozole and abemaciclib together may slow down cancer cell growth in patients with endometrial cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine whether there are changes in Ki-67 expression from the pretreatment specimen (e.g. biopsy or dilation and curettage \[D\&C\]) to the post-treatment hysterectomy specimen following treatment with letrozole and abemaciclib. SECONDARY OBJECTIVES: I. To determine the proportion of tumors with complete cell cycle arrest (CCCA) response as measured by Ki-67 expression between the pre-treatment tumor and the posttreatment tumor. II. To identify biological characteristics of tumors (e.g. mismatch repair \[MMR\] status, PTEN mutational status, etc.) correlating with decreased Ki-67 expression induced by the letrozole and abemaciclib combination. III. To determine the frequency of adverse events associated with use of abemaciclib and letrozole. EXPLORATORY OBJECTIVES: I. To evaluate the correlation of the expression of Ki-67 with that of cyclin D1, p16, pRB, and PTEN as well as with MMR deficiency. OUTLINE: Patients receive letrozole orally (PO) once daily (QD) and abemaciclib PO twice daily (BID) on days 1-14. Patients then undergo standard of care hysterectomy on day 15. After completion of study treatment, patients are followed up at 30 days and at 2 and 6 weeks after surgery.

Conditions

• Endometrial Endometrioid Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Abemaciclib	Given PO
DRUG	Letrozole	Given PO
PROCEDURE	Therapeutic Conventional Surgery	Undergo standard of care hysterectomy

Timeline

• Start date: 2019-08-12
• Primary completion: 2023-04-01
• Completion: 2023-05-15
• First posted: 2019-08-08
• Last updated: 2025-10-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study