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.
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.
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
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.
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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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