Trial of Letrozole + Palbociclib/Placebo in Metastatic Endometrial Cancer

Phase 2 Completed 78 enrolled Nordic Society of Gynaecological Oncology - Clinical Trials Unit European Network of Gynaecological Oncological Trial Groups (ENGOT) · collab Grupo Español de Investigación en Cáncer de Ovario · collab Gynecologic Cancer Intergroup (GCIG) · collab Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies (MITO) · collab North Eastern German Society of Gynaecological Oncology · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This randomized double-blind, placebo-controlled phase 2 trial is evaluating superiority of Letrozole-palbociclib combination versus letrozole-placebo combination in ER positive endometrioid adenocarcinoma of endometrium

Timeline

Start: 2017-02-15
Primary completion: 2020-12-15
Completion: 2021-12-15

Outcome

Met primary endpoint

paper Median PFS was 8.3 (95 % CI, 4.6 to 11.2) versus 3.1 (95 % CI, 2.7 to 6.8) months, respectively. PMID 39657575 ↗

paper In a landmark analysis at 12 months the PFS hazard ratio was 0.57 (95 % CI, 0.32 to 0.99; P = .044). PMID 39657575 ↗

Publications

Mirza MR, Bjorge L, Marme F, Christensen RD, Gil-Martin M, Auranen A, Ataseven B, Rubio MJ, Salutari V, Luczak AA, Runnebaum IB, Redondo A, Lindemann K, Trillsch F, Ginesta MPB, Roed H, Kurtz JE, Petersson KS, Nyvang GB, Sehouli J. Palbociclib plus letrozole in estrogen receptor-positive advanced/recurrent endometrial cancer: Double-blind placebo-controlled randomized phase II ENGOT-EN3/PALEO trial. Gynecol Oncol. 2025 Jan;192:128-136. doi: 10.1016/j.ygyno.2024.12.003. Epub 2024 Dec 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Palbociclib	Small molecule	125 mg	Oral
Background	Letrozole	Other / unclassified	2.5 mg	Oral