NCT06492616Recruiting
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
Summary
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
Inclusion criteria
• Histopathologically or cytologically confirmed ER+ (≥10% by immunohistochemistry \[IHC\]), HER2- (tumors with an IHC score of 0, 1+, or 2+ with in situ hybridization \[ISH\]-negative \[not amplified\]). ISH-negative without IHC testing will also be eligible on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases, per local laboratory, according to the American Society of Clinical Oncology/College of American Pathologists guidelines. • Participants must be node positive (microscopic and macroscopic tumor involvement are allowed) and fulfill one of the following criteria: 1. ≥4 positive axillary lymph nodes or 2. 1-3 positive axillary lymph nodes and 1. Histologic grade 3 disease and/or 2. Tumor size ≥5 centimeters and/or 3. High genomic risk (identified by Oncotype, MammaPrint, EndoPredict, PAM50) • Participants who are currently taking endocrine therapy (aromatase inhibitors or tamoxifen) and have received at least 24 months but not more than 60 months of endocrine therapy at the time of randomization (Cycle 1 Day 1 \[C1D1\]) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i) and with or without a luteinizing hormone-releasing hormone agonist. • Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase inhibitor must have already completed or discontinued these treatments.
Exclusion criteria
• Participants with inflammatory breast cancer. • History of any prior (ipsilateral and/or contralateral) invasive breast cancer. • Participant with history of non-breast malignancy within 3 years of the date of randomization, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix. • Participants who have had more than a 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who are off current adjuvant endocrine therapy more than 6 months prior to randomization. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Finland, Georgia, Hong Kong, Hungary, Malaysia, Netherlands, Poland, Portugal, Romania, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
- Sponsor
- Stemline Therapeutics, Inc.(Industry)
- Protocol no.
- STML-ELA-0422
- Conditions
- Breast Cancer
- Interventions
- Drug
Treatments studied
- Elacestrant
- Anastrozole
- Letrozole
- Exemestane
- Tamoxifen
Locations · 501
- Aarau, SwitzerlandTumor Zentrum AarauRecruiting at this site
- Baden, SwitzerlandKantonsspital BadenvRecruiting at this site
- Liestal, SwitzerlandKantonsspital BasellandRecruiting at this site
- Basel, SwitzerlandUniversitätsspital BaselRecruiting at this site
- Sankt Gallen, SwitzerlandHOCH Health Ostschweiz - Kantonsspital St.GallenRecruiting at this site
- Lausanne, SwitzerlandCentre Hospitalier Universitaire Vaudois (CHUV)Département d'oncologieRecruiting at this site
- Winterthur, SwitzerlandKantonsspital WinterthurRecruiting at this site
- Zurich, SwitzerlandBrust-Zentrum AG ZurichRecruiting at this site
- Bern, SwitzerlandInselspital, Universitätsspital BernRecruiting at this site
- Geneva, SwitzerlandHopitaux Universitaires de Geneve (HUG) - Hopital CantonalRecruiting at this site
- Schaffhausen, SwitzerlandSpitaeler Schaffhausen KantonspitalRecruiting at this site
- Zurich, SwitzerlandUniversitätsspital ZürichRecruiting at this site
- Strasbourg, FranceInst Cancerologie Strasbourg EuropeRecruiting at this site
- Grenoble, FranceCHU de GrenobleRecruiting at this site
- Valenciennes, FranceCentre de cancerologie Les DentellieresRecruiting at this site
- Montpellier, FranceCentre de Cancérologie du Grand MontpellierRecruiting at this site
- Chambray-lès-Tours, FranceCt Oncologie Radiotherapie CORT 37Recruiting at this site
- Limoges, FranceHopital Universitaire DupuytrenRecruiting at this site
- La Chaussée-Saint-Victor, FrancePolyclinique de BloisRecruiting at this site
- Saint-Herblain, FranceInstitut de Cancerologie de l'Ouest - OncologyRecruiting at this site
- Bezannes, FranceICONERecruiting at this site
- Reims, FranceCRLCC Jean GodinotRecruiting at this site
- Clermont-Ferrand, FranceCentre Jean PerrinRecruiting at this site
- Pau, FranceCentre Hospitalier De PauRecruiting at this site
- Dijon, FranceInstitut de Cancerologie BourgogneRecruiting at this site
- Amiens, FranceCHU Amiens - Picardie Site SudRecruiting at this site
- Villejuif, FranceInstitut Gustave RoussyRecruiting at this site
- Fréjus, FranceCHI De Fréjus / Saint-RaphaelRecruiting at this site
- Avignon, FranceInstitut Sainte CatherineRecruiting at this site
- La Roche-sur-Yon, FranceCHD VendeeRecruiting at this site
In total, worldwide, 501 of the 567 sites listed in the registry are recruiting; the other 66 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: September 15, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 471 more locations
Other identifiers
- 2024-515445-42-00 · CTIS number
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.