ALPINE: Maintenance Letrozole/Abemaciclib

Recruiting Phase 2 Interventional Study
Endometrial Cancer Recurrent Endometrial Cancer TP53
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
32 (estimated)
Sponsor
Dana-Farber Cancer Institute · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participants must have histologically confirmed either i) endometrioid endometrial cancer or ii) endometrial carcinosarcoma with endometrioid epithelial component. * Participants must have ER-positive disease, defined as ≥ 1 percent of tumor cell nuclei being immunoreactive by…
Contacts

Panagiotis Konstantinopoulos, MD, PhD

617-632-2334

Panagiotis_Konstantinopoulos@DFCI.HARVARD.EDU

CONTACT