Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT04049227
Status:
COMPLETED
Last Update Posted:
2025-10-17
First Post:
2019-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Abemaciclib and Letrozole in Treating Patients With Endometrial Cancer
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
A Pilot, Multicenter, Single Arm, Open Label, Surgical Window of Opportunity Study of Abemaciclib and Letrozole for Endometrioid Adenocarcinoma of the Endometrium
Status:
COMPLETED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| STU00209370 | None | CTRP (Clinical Trial Reporting Program) | View | |
| NU 18G07 | OTHER | Northwestern University | View | |
| P30CA060553 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2019-04599 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |