Actively Recruiting
Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.
Led by MedSIR · Updated on 2026-04-03
240
Participants Needed
99
Research Sites
173 weeks
Total Duration
On this page
Sponsors
M
MedSIR
Lead Sponsor
S
Stemline Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive/human epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer. The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus everolimus therapy in patients who have ER-positive/HER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival. Rigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.
CONDITIONS
Official Title
Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the study and provide written informed consent.
- Female or male patients aged 18 years or older.
- Premenopausal or perimenopausal women must be receiving LHRH analogues for at least 28 days before randomization; postmenopausal women meet specific age or hormonal criteria.
- Histologically or cytologically confirmed adenocarcinoma of the breast with unresectable locally recurrent or metastatic disease.
- Tumor is estrogen receptor-positive (at least 10% positive cells) and HER2-negative as per guidelines.
- ESR1 mutation status determined by validated tests before randomization.
- Evidence of disease progression on prior CDK4/6 inhibitor and endocrine therapy after at least 6 months of treatment.
- Received at least one and no more than two lines of endocrine therapy for advanced breast cancer.
- No prior treatment with elacestrant or other investigational SERDs, PROTACs, CERANs, novel SERMs, or PI3K/AKT/mTOR inhibitors including everolimus for advanced disease.
- No prior chemotherapy for advanced disease.
- Presence of measurable or evaluable disease including bone-only disease with specific lesions.
- Willingness to provide recent tumor tissue samples or archival tissue.
- Fasting serum cholesterol ≤ 300 mg/dL and fasting triglycerides ≤ 2.5 times the upper limit of normal.
- Adequate bone marrow, liver, kidney function, and coagulation status.
- Resolution of acute toxic effects from prior cancer therapy to grade 1 or less.
- Women of childbearing potential must have negative pregnancy test and agree to use effective contraception.
- Male participants with partners of childbearing potential must use contraception or abstain.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 12 weeks at screening.
You will not qualify if you...
- Unable to comply with study and follow-up procedures.
- Contraindication to endocrine therapy such as visceral crisis or rapidly progressive visceral disease.
- Currently participating in another therapeutic clinical trial.
- Treatment with cancer therapy within 14 days before randomization except completed fulvestrant at least 28 days prior.
- Active uncontrolled or symptomatic central nervous system metastases.
- Intact uterus with history of certain endometrial lesions.
- Other malignancies within 3 years except certain low-risk cancers.
- Known allergy or hypersensitivity to study drugs.
- Conditions interfering with pill swallowing or absorption.
- Recent radiotherapy with wide field or significant bone marrow exposure.
- Major surgery or significant injury within 14 days before randomization.
- Significant cardiovascular or cerebrovascular disease within 6 months.
- Uncontrolled atrial fibrillation or significant cardiac arrhythmias.
- Severe pulmonary illnesses or conditions.
- History or presence of interstitial lung disease or pneumonitis.
- Recent coagulopathy or thrombotic events unless stable and treated.
- Use of immunosuppressive agents or chronic corticosteroids except certain low doses or local uses.
- Unable or unwilling to avoid medications or foods that affect CYP3A4 enzyme activity.
- Pregnant or lactating women or unwillingness to use contraception.
- Active infection with HIV, hepatitis B or C unless resolved as specified.
- Known substance abuse or uncontrolled psychiatric or medical conditions contraindicating participation.
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Trial Site Locations
Total: 99 locations
1
Medizinische Universität Innsbruck
Innsbruck, Austria
Actively Recruiting
2
Ordensklinikum Linz Barmherzige Schwestern
Linz, Austria
Actively Recruiting
3
Ordination Priv.-Doz. Dr. Michael Hubalek
Schwaz, Austria
Actively Recruiting
4
Medical University of Vienna
Vienna, Austria
Not Yet Recruiting
5
Tacchini Instituto de Pesquisa
Bento Gonçalves, Brazil
Not Yet Recruiting
6
Hospital Cachoeiro de Itapemirim
Cachoeiro de Itapemirim, Brazil
Not Yet Recruiting
7
Catarina Pesquisa Clínica - Neoplasias Litoral
Itajaí, Brazil
Not Yet Recruiting
8
UPCO - Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
Not Yet Recruiting
9
NOB Ondina
Salvador, Brazil
Not Yet Recruiting
10
Masaryk Memorial Cancer Institute
Brno, Czechia
Actively Recruiting
11
Multiscan Nemocnice Horovice
Hořovice, Czechia
Actively Recruiting
12
University Hospital Olomouc
Olomouc, Czechia
Not Yet Recruiting
13
General University Hospital Prague
Prague, Czechia
Actively Recruiting
14
Tomas Bata Regional Hospital in Zlin
Zlín, Czechia
Actively Recruiting
15
Polyclinique Bordeaux Nord Aquitaine
Bordeau, France
Actively Recruiting
16
Institut Bergonié Bordeaux
Bordeaux, France
Not Yet Recruiting
17
Centre Georges François Leclerc
Dijon, France
Actively Recruiting
18
Centre Hospitalier de Limoges
Limoges, France
Actively Recruiting
19
CHU Lyon Sud
Lyon, France
Actively Recruiting
20
Institut Paoli Calmettes
Marseille, France
Not Yet Recruiting
21
APHP Tenon
Paris, France
Not Yet Recruiting
22
Hospital prive des Cotes d'Amor
Plérin, France
Actively Recruiting
23
CHU Saint Etienne
Saint-Priest-en-Jarez, France
Actively Recruiting
24
IUCT Oncopole
Toulouse, France
Actively Recruiting
25
Institute de Cancerologie de Lorraine - Nancy
Vandœuvre-lès-Nancy, France
Actively Recruiting
26
MVZ Klinikum Aschaffenburg
Aschaffenburg, Germany
Not Yet Recruiting
27
Hämatologie-Onkologie im Zentrum MVZ GmbH
Augsburg, Germany
Not Yet Recruiting
28
Städtisches Klinikum Dessau
Dessau, Germany
Not Yet Recruiting
29
Universitätsklinikum Dusseldorf
Düsseldorf, Germany
Not Yet Recruiting
30
Universitätsklinikum Essen
Essen, Germany
Not Yet Recruiting
31
MVZ II der Niels Stensen Kliniken
Georgsmarienhütte, Germany
Actively Recruiting
32
Klinikum Worms - Frauenklinik
Worms, Germany
Actively Recruiting
33
University General Hospital Alexandroupoli
Alexandroupoli, Greece
Actively Recruiting
34
251 Air Force General Hospital
Athens, Greece
Actively Recruiting
35
Aretaeio Hospital
Athens, Greece
Actively Recruiting
36
Attikon University Hospital
Athens, Greece
Actively Recruiting
37
Metropolitan General Hospital 4th department
Athens, Greece
Actively Recruiting
38
University General Hospital of Heraklion
Heraklion, Greece
Actively Recruiting
39
University General Hospital of Larissa
Larissa, Greece
Actively Recruiting
40
General University Hospital of Patras
Pátrai, Greece
Actively Recruiting
41
Metropolitan Hospital Greece 1st department
Piraeus, Greece
Actively Recruiting
42
EU Interbalkan Medical Center
Thessaloniki, Greece
Actively Recruiting
43
Cliniche Gavazzeni
Bergamo, Italy
Not Yet Recruiting
44
Azienda Ospedaliero-Universitaria (AOU) di Cagliari
Cagliari, Italy
Not Yet Recruiting
45
Aou Careggi
Florence, Italy
Actively Recruiting
46
IRCCS Ospedale Policlinico San Martino
Genova, Italy
Not Yet Recruiting
47
Ospedali Riuniti Livorno
Livorno, Italy
Actively Recruiting
48
Instituto Europeo di Oncologia
Milan, Italy
Actively Recruiting
49
AOU Policilinico Modena
Modena, Italy
Actively Recruiting
50
IRCCS San Gerardo
Monza, Italy
Not Yet Recruiting
51
Fondazione Pascale
Naples, Italy
Not Yet Recruiting
52
Azienda Ospedaliero- Universitaria Maggiore Della Carita
Novara, Italy
Actively Recruiting
53
Oncologia Medica AUSL Piacenza
Piacenza, Italy
Actively Recruiting
54
Policlinico A. Gemelli IRCCS
Roma, Italy
Not Yet Recruiting
55
Hospital Universitari Dexeus
Barcelona, Barcelona, Spain
Actively Recruiting
56
Centro Oncológico de Galicia
A Coruña, Spain
Actively Recruiting
57
Complejo Hospitalario Universitario de Santiago (CHUS)
A Coruña, Spain
Actively Recruiting
58
Hospital General Universitario Dr. Balmis (Alicante)
Alicante, Spain
Actively Recruiting
59
Hospital Universitario San Juan de Alicante
Alicante, Spain
Actively Recruiting
60
Institut Català d' Oncologia Badalona (ICO)
Badalona, Spain
Actively Recruiting
61
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain
Actively Recruiting
62
Hospital del Mar
Barcelona, Spain
Actively Recruiting
63
Hospital Universitari Vall D'Hebron
Barcelona, Spain
Actively Recruiting
64
Hospital Universitario de Basurto
Bilbao, Spain
Actively Recruiting
65
Hospital Universitario de Burgos
Burgos, Spain
Actively Recruiting
66
Hospital Provincial de Castellón
Castellon, Spain
Actively Recruiting
67
Hospital San Pedro de Alcántara
Cáceres, Spain
Actively Recruiting
68
Hospital Universitario Clínico San Cecilio de Granada
Granada, Spain
Actively Recruiting
69
Complejo Hospitalario de Jaén
Jaén, Spain
Actively Recruiting
70
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Spain
Actively Recruiting
71
Hospital Universitario de León
León, Spain
Actively Recruiting
72
Hospital Universitario Arnau de Vilanova de Lleida
Lleida, Spain
Actively Recruiting
73
Hospital Beata María Ana
Madrid, Spain
Actively Recruiting
74
Hospital Universitario Doce de Octubre
Madrid, Spain
Actively Recruiting
75
Hospital Universitario La Paz
Madrid, Spain
Actively Recruiting
76
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain
Actively Recruiting
77
Hospital Universitario Ramón y Cajal
Madrid, Spain
Actively Recruiting
78
Hospital Universitario Sanchinarro-START-CIOCC
Madrid, Spain
Actively Recruiting
79
MD Anderson Cancer Center Madrid
Madrid, Spain
Actively Recruiting
80
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
Actively Recruiting
81
Hospital Universitari Son Espases
Palma de Mallorca, Spain
Actively Recruiting
82
Hospitalario Universitario de Navarra
Pamplona, Spain
Actively Recruiting
83
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain
Actively Recruiting
84
Hospital Quirónsalud Sagrado Corazón
Seville, Spain
Actively Recruiting
85
Hospital Universitario Virgen del Rocío
Seville, Spain
Actively Recruiting
86
Hospital Universitario Virgen Macarena
Seville, Spain
Actively Recruiting
87
Hospital Universitari Sant Joan de Reus
Tarragona, Spain
Actively Recruiting
88
Hospital Universitario Marqués de Valdecilla
Valdecilla, Spain
Actively Recruiting
89
Consorci Hospital General Universitari de València
Valencia, Spain
Actively Recruiting
90
Hospital Arnau de Vilanova de Valencia
Valencia, Spain
Actively Recruiting
91
Hospital Clínico Universitario de Valencia
Valencia, Spain
Actively Recruiting
92
Hospital Universitario La Ribera - Alzira
Valencia, Spain
Actively Recruiting
93
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Actively Recruiting
94
Western General Hospital
Edinburgh, United Kingdom
Not Yet Recruiting
95
Barts Health NHS Trust
London, United Kingdom
Actively Recruiting
96
Genesis Care Oxford
Oxford, United Kingdom
Actively Recruiting
97
Royal Surrey County Hospital
Surrey Quays, United Kingdom
Actively Recruiting
98
Royal Cornwall Hospital NHS Trust
Truro, United Kingdom
Actively Recruiting
99
Genesis Cancer Care UK
Waterlooville, United Kingdom
Actively Recruiting
Research Team
M
Medsir
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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