NCT05634499 (EndomERA) is a Phase 2 clinical trial of Giredestrant in Endometrial Cancer, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT05634499?

NCT05634499 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT05634499?

Interventions in NCT05634499: Giredestrant.

What condition does NCT05634499 study?

NCT05634499 studies Endometrial Cancer.

Is NCT05634499 still recruiting?

NCT05634499 is currently active, enrolled. Last updated 13 April 2026.

Last reviewed 2026-04-13 · How we verify

NCT05634499: EndomERA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Giredestrant in Participants With Grade 1 Endometrial Cancer

Active, enrolled Phase 2 Last updated 13 April 2026

What this trial tests

Phase 2 trial testing Giredestrant in Endometrial Cancer in 30 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 June 2023

Primary endpoint
28 August 2026

28 August 2026

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	27 June 2023
Primary completion	28 August 2026
Estimated completion	28 August 2026
Sites	12 locations across Italy, Canada, United States, Poland

Drugs / interventions tested

Giredestrant — full drug profile →

Conditions studied

Endometrial Cancer — all drugs for Endometrial Cancer →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, female only, with Endometrial Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This Phase II, global, single-arm study is designed to evaluate the efficacy, safety, and pharmacokinetics of giredestrant monotherapy in participants with Grade 1 endometrioid endometrial cancer.

Publications & conference data

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

Optimization of small molecule degraders and antagonists for targeting estrogen receptor based on breast cancer: current status and future.
Yao J, Tao Y, Hu Z, Li J, et al · · 2023 · cited 5× · PMID 37808197 · DOI 10.3389/fphar.2023.1225951
Endocrine Therapy for Endometrial Carcinoma: Current Evidence, Resistance Mechanisms, and Biomarker-Driven Patient Selection.
Yamanaka T, Yoshida H, Shimoi T, Sudo K, et al · · 2026 · PMID 41744888 · DOI 10.3390/curroncol33020124

Verify or expand the search:

Other trials of Giredestrant

Trials testing the same drug.

NCT07214662 — A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Gire · Phase 1 · recruiting
NCT07100106 — A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestran · Phase 1, PHASE2 · recruiting
NCT05708235 — A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population · Phase 2 · recruiting
NCT05896566 — A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients Wi · Phase 2 · completed
NCT06065748 — A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Particip · Phase 3 · recruiting

Other recruiting trials for Endometrial Cancer

Currently open trials in the same condition.

NCT07419841 — A Phase 1 Study of the Safety and Tolerability of CTX-10726 · Phase 1 · recruiting
NCT07382583 — Development of a Shared Decision Tool to Facilitate Uptake of the Levonorgestrel-releasing Intrauterine System for the P · recruiting
NCT07377734 — Intrauterine Injection of Type III Collage in FST of EC/AEH · Phase 2 · recruiting
NCT07319429 — Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification · Phase 2, PHASE3 · recruiting
NCT07397624 — Endoscopic Suture Gastroplasty (ESG) for Treatment of Obese Patients With Endometrial Cancer · recruiting

Other Hoffmann-La Roche trials

Trials by the same sponsor.

NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05634499 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 13 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05634499.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing