NCT03008408

A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma

Active, enrolled Phase 2 Last updated 11 February 2026

What this trial tests

Phase 2 trial testing Everolimus in Recurrent Endometrial Carcinoma in 90 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

18 August 2017

Primary endpoint
31 August 2028

31 August 2028

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	18 August 2017
Primary completion	31 August 2028
Estimated completion	31 August 2028
Sites	2 locations across United States

Drugs / interventions tested

• Everolimus (everolimus) — full drug profile →
• Letrozole — full drug profile →
• Ribociclib (ribociclib) — full drug profile →

Conditions studied

• Recurrent Endometrial Carcinoma — all drugs for Recurrent Endometrial Carcinoma →
• Recurrent Endometrial Endometrioid Adenocarcinoma — all drugs for Recurrent Endometrial Endometrioid Adenocarcinoma →
• Refractory Endometrial Carcinoma — all drugs for Refractory Endometrial Carcinoma →
• Refractory Endometrial Endometrioid Adenocarcinoma — all drugs for Refractory Endometrial Endometrioid Adenocarcinoma →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, female only, with Recurrent Endometrial Carcinoma or Recurrent Endometrial Endometrioid Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies how well everolimus and letrozole with or without ribociclib work in treating participants with endometrial cancer that has spread to other areas of the body or has come back. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs such as everolimus and letrozole have been shown to be effective at stopping tumor growth either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib, everolimus, and letrozole may work better than everolimus and letrozole in treating participants with endometrial cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. CDK4 and CDK6 kinases: From basic science to cancer therapy.
   Fassl A, Geng Y, Sicinski P. · · 2022 · cited 351× · PMID 35025636 · DOI 10.1126/science.abc1495
2. CDK4/6 Inhibitors: The Mechanism of Action May Not Be as Simple as Once Thought.
   Klein ME, Kovatcheva M, Davis LE, Tap WD, et al · · 2018 · cited 308× · PMID 29731395 · DOI 10.1016/j.ccell.2018.03.023
3. Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
   Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6
4. Selective inhibition of CDK4/6: A safe and effective strategy for developing anticancer drugs.
   Yuan K, Wang X, Dong H, Min W, et al · · 2021 · cited 103× · PMID 33532179 · DOI 10.1016/j.apsb.2020.05.001
5. Immunotherapy in endometrial cancer: new scenarios on the horizon.
   Di Tucci C, Capone C, Galati G, Iacobelli V, et al · · 2019 · cited 83× · PMID 30887763 · DOI 10.3802/jgo.2019.30.e46
6. Endometrial Cancer Stem Cells: Role, Characterization and Therapeutic Implications.
   Giannone G, Attademo L, Scotto G, Genta S, et al · · 2019 · cited 68× · PMID 31752447 · DOI 10.3390/cancers11111820
7. Everolimus, Letrozole, and Metformin in Women with Advanced or Recurrent Endometrioid Endometrial Cancer: A Multi-Center, Single Arm, Phase II Study.
   Soliman PT, Westin SN, Iglesias DA, Fellman BM, et al · · 2020 · cited 64× · PMID 31628143 · DOI 10.1158/1078-0432.ccr-19-0471
8. Targeting Cyclin-Dependent Kinases for Treatment of Gynecologic Cancers.
   Lin ZP, Zhu YL, Ratner ES. · · 2018 · cited 43× · PMID 30135856 · DOI 10.3389/fonc.2018.00303