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Promising combo aims to stall advanced breast cancer

NCT ID NCT06382948

Disease control Sponsor: MedSIR Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 4 times

Summary

This study tests whether adding everolimus to elacestrant can help people with a certain type of advanced breast cancer (ER+/HER2- with an ESR1 mutation) live longer without their cancer getting worse. About 240 adults whose cancer has stopped responding to standard hormone therapy and CDK4/6 inhibitors will receive either the drug combo or elacestrant alone. The goal is to see if the combination delays disease progression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients will be included in the study only if they meet ALL of the following criteria: 1. Patient must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures. 2. Female or male patients ≥ 18 years of age at the time of signing ICF. 3. Pre- or perimenopausal women, who do not meet the criteria for post-menopausal status (defined in continuation) and men must be concurrently receiving a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol/follicle-stimulating hormone \[FSH\] must be confirmed analytically) prior to study randomization and are planning to continue LHRH agonist treatment during the study. Post-menopausal women as defined by any of the following criteria: 1. Age ≥ 60 years; 2. Age \< 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and/or FSH levels within the laboratory's reference range for post-menopausal females; 3. Documented bilateral surgical oophorectomy. 4. Histologically- or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either unresectable locally recurrent or metastatic disease confirmed by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent. 5. Documentation of ER\[+\] (≥10% positive stained cells) and HER2\[-\] (0-1+ by immunohistochemistry \[IHC\] or 2+ and negative by in situ hybridization \[ISH\] test) tumor according to the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as per local assessment. ER\[+\]/HER2\[-\] status should be confirmed in metastatic setting, with exception of patients with bone and lung only disease. 6. Patients with ESR1 mutational status will be determined before patient randomization using Guardant360 CDx (Guardant Health) test. Note: Patients with previously determined ESR1 mutation using appropriately validated tests (Guardant360 CDx \[Guardant Health\], FoundationOne CDx, FoundationOne Liquid \[Foundation Medicine Inc\]) will be eligible for inclusion. This local determination can be performed either in blood or tumor samples. 7. Radiological or objective evidence of disease progression on prior treatment with a CDK4/6 inhibitor in combination with endocrine therapy for advanced disease after at least 6 months of treatment. Patients receiving CDK4/6 inhibitor-based therapy in the adjuvant setting are also eligible provided that disease progression is confirmed after at least 12 months of treatment but no more than 12 months following CDK4/6 inhibitor treatment completion in this scenario. 8. Patients must have previously received at least one and no more than two lines of endocrine therapy for ABC. Progression during or within 12 months of adjuvant endocrine therapy is considered as a line of endocrine therapy for advanced disease. 9. No prior elacestrant or other investigational SERDs, proteolysis targeting chimera (PROTAC), complete estrogen receptor antagonist (CERAN), or novel SERM, and/or PI3K/AKT/mTOR inhibitors, including everolimus, for advanced disease are permitted. Note: Fulvestrant is permitted if treatment was completed administered at least 28 days before randomization. 10. No prior chemotherapy for advanced disease is allowed. 11. Evidence of measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1), or non-measurable, but evaluable, disease, including bone-only disease with at least one lytic or mixed lytic-blastic bone lesion. 12. Willingness and ability to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue or block. If a newly obtained baseline biopsy of an accessible tumor lesion is not possible to be obtained prior randomization, an archival tissue sample will be accepted. 13. Fasting serum cholesterol ≤ 300 mg/dL or 7.75 mmol/L and fasting triglycerides ≤ 2.5 times the upper limit of normal (x ULN). 14. Adequate bone marrow and organ function: 1. Hematological (without platelet, red blood cell transfusion, and/or granulocyte colony-stimulating factor support within seven days before randomization): absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelet count ≥ 100.0 x109/L; and hemoglobin ≥ 9.0 g/dL. 2. Hepatic: Serum albumin ≥ 2.5 g/dL; total serum bilirubin \< 1.5 x ULN except for patients with Gilbert's syndrome who may be included if the total serum bilirubin is ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN; alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 3 x ULN in patients with liver and/or bone metastases); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 x ULN (≤ 3 x ULN in patients with liver metastases). 3. Renal: Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50 mL/min as calculated by Cockcroft- Gault equation. 4. Coagulation: International normalized ratio (INR) ≤ 1.5 x ULN, unless that the patient meets the exception described in the exclusion criteria 16. 15. Resolution of all acute toxic effects of prior anti-cancer therapy to grade ≤ 1 as determined by the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 (except for toxicities not considered a safety risk for the patient at Investigator's discretion). Note: Patients with grade 2 alopecia are allowed. 16. Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 7 days before randomization. In addition, they agree to use one highly effective method of birth control 28 days prior to start of treatment until 120 days after the last dose of study treatments. Female patients must refrain from egg cell donation and breastfeeding during this same time period. 17. Male participants with a female partner of childbearing potential must be surgically sterile or using a highly effective method of contraception 28 days prior to treatment until 120 days after the last dose of study treatments to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period. Not engaging in heterosexual activity (sexual abstinence) for the duration of the study and 120 days after the last dose of study treatments is an acceptable practice if this is the preferred usual lifestyle of the participant. 18. ECOG performance status of 0-1. 19. Minimum life expectancy of ≥ 12 weeks at screening. Exclusion Criteria: Any patient meeting ANY of the following criteria will be excluded from the study: 1. Inability to comply with study and follow-up procedures. 2. Formal contraindication to endocrine therapy defined as visceral crisis and/or rapidly or symptomatic progressive visceral disease. 3. Current participation in another therapeutic clinical trial. 4. Treatment with approved or investigational cancer therapy within 14 days prior to randomization except for fulvestrant that must be administered completed at least 28 days before randomization. 5. Known active uncontrolled or symptomatic central nervous system (CNS) metastases and/or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases are eligible if they have been previously treated with local therapy, are clinically stable, and off anticonvulsants and steroids for at least 14 days before randomization. 6. Intact uterus with a history of endometrial intraepithelial neoplasia (atypical endometrial hyperplasia or higher-grade lesion). 7. Concurrent malignancy or malignancy within three years before randomization with the exception of carcinoma in situ of the cervix, non-melanoma skin carcinoma, or stage I uterine cancer. For other cancers considered to have a low risk of recurrence, discussion with the Medical Monitor is required. 8. Known allergy or hypersensitivity reaction to any investigational medicinal products (IMPs) or their incorporated substances. 9. History of malabsorption syndrome or other condition that would interfere with enteral absorption (ongoing gastrointestinal obstruction/motility disorder, malabsorption syndrome, or prior gastric bypass) or results in the inability or unwillingness to swallow pills. 10. Palliative radiotherapy with a limited field of radiation within two weeks or with wide field of radiation or to more than 30% of the bone marrow within four weeks prior to randomization. 11. Major surgical procedure or significant traumatic injury within 14 days before randomization or anticipation of need for major surgery within the course of the study treatment. 12. Clinically relevant cardiovascular/cerebrovascular disease and/or cardiac dysfunction or conduction abnormalities including, but not confined, to any of the following: a. Symptomatic pericarditis, unstable angina pectoris, documented myocardial infarction, coronary/peripheral artery bypass graft, symptomatic cardiac heart failure (CHF) (New York Heart Association \[NYHA\] Class II-IV), or cerebrovascular accident including transient ischemic attack within six months before study randomization. 13. Concurrent uncontrolled atrial fibrillation, other ongoing cardiac dysrhythmias grade ≥ 2 as determined by NCI-CTCAE v.5.0, or prolonged QT Interval Corrected by Fridericia's formula (\[QTcF\] \> 480 msec). 14. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited, to any of the following: 1. Massive lung metastatic involvement (e.g., pleural effusion, lymphangitic carcinomatosis, etc.). 2. Any underlying pulmonary disorder (e.g., severe asthma, severe chronic obstructive pulmonary disease \[COPD\], restrictive lung disease, post Coronavirus disease (COVID-19) pulmonary fibrosis, etc.). 3. Any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.). 4. Prior pneumonectomy. 15. History of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. 16. Coagulopathy or any history of coagulopathy within six months before study enrollment, including history of deep vein thrombosis or pulmonary embolism. However, patients with the following conditions will be allowed to participate: 1. Adequately treated catheter-related venous thrombosis occurring more than 28 days prior to randomization. 2. Treatment with an anticoagulant (e.g., warfarin or heparin) for a thrombotic event occurring more than six months before randomization, or for an otherwise stable and allowed medical condition (e.g., well controlled atrial fibrillation), provided dose and coagulation parameters (as defined by local standard of care) are stable for at least 28 days prior to randomization. 17. Concomitant treatment with immunosuppressive agents or chronic corticosteroids use before randomization with the following exceptions: topical applications, inhaled sprays, eye drops, mouthwash, or local injections are allowed. Patients on stable low dose of corticosteroids ( ≤ 10 mg/day of prednisone or equivalent) for at least two weeks before randomization are also permitted. 18. Unable or unwilling to avoid prescription medications, over-the-counter medications, dietary/herbal supplements (e.g., St. John's wort), and/or foods (e.g., grapefruit, pomelos, star fruit, Seville oranges and their juices) that are moderate/strong inhibitors or inducers of CYP3A4 activity. Participation will be allowed if the medication, supplements, and/or foods are discontinued for at least five half-lives or 14 days (whichever is shorter) prior to randomization and for the duration of the study. 19. Pregnant or lactating women or patients not willing to apply highly effective contraception as defined in the protocol. 20. Current known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antibody \[HBsAg\] test and a positive hepatitis B core antibody \[HBcAb\] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. Any other active uncontrolled infection at the time of screening is not allowed. 21. Known substance abuse or any other concurrent severe and/or uncontrolled psychiatric or medical condition that would, in the Investigator's judgment, contraindicate patient participation.

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Conditions

The condition(s) this trial relates to.

breast cancer estrogen-receptor positive breast cancer Her2-receptor negative breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced breast cancer ER-positive breast cancer ESR1 gene mutation HER2-negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    103 sites in 9 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • 251 Air Force General Hospital

    RECRUITING

    Athens, Greece

  • AOU Policilinico Modena

    RECRUITING

    Modena, Italy

  • APHP Tenon

    NOT_YET_RECRUITING

    Paris, France

  • Aou Careggi

    RECRUITING

    Florence, Italy

  • Aretaeio Hospital

    RECRUITING

    Athens, Greece

  • Attikon University Hospital

    RECRUITING

    Athens, Greece

  • Azienda Ospedaliero- Universitaria Maggiore Della Carita

    RECRUITING

    Novara, Italy

  • Azienda Ospedaliero-Universitaria (AOU) di Cagliari

    NOT_YET_RECRUITING

    Cagliari, Italy

  • Barts Health NHS Trust

    RECRUITING

    London, United Kingdom

  • CHU Lyon Sud

    RECRUITING

    Lyon, France

  • CHU Saint Etienne

    RECRUITING

    Saint-Priest-en-Jarez, France

  • Catarina Pesquisa Clínica - Neoplasias Litoral

    NOT_YET_RECRUITING

    Itajaí, Brazil

  • Centre Georges François Leclerc

    RECRUITING

    Dijon, France

  • Centre Hospitalier de Limoges

    RECRUITING

    Limoges, France

  • Centre Paul Strauss

    RECRUITING

    Strasbourg, France

  • Centro Oncológico de Galicia

    RECRUITING

    A Coruña, Spain

  • Cliniche Gavazzeni

    NOT_YET_RECRUITING

    Bergamo, Italy

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    RECRUITING

    A Coruña, Spain

  • Complejo Hospitalario de Jaén

    RECRUITING

    Jaén, Spain

  • Consorci Hospital General Universitari de València

    RECRUITING

    Valencia, Spain

  • EU Interbalkan Medical Center

    RECRUITING

    Thessaloniki, Greece

  • Fondazione Pascale

    NOT_YET_RECRUITING

    Naples, Italy

  • Fundacion Althaia

    RECRUITING

    Manresa, Spain

  • General University Hospital Prague

    RECRUITING

    Prague, Czechia

  • General University Hospital of Patras

    RECRUITING

    Pátrai, Greece

  • Genesis Cancer Care UK

    RECRUITING

    Waterlooville, United Kingdom

  • Genesis Care Oxford

    RECRUITING

    Oxford, United Kingdom

  • Hospital Arnau de Vilanova de Valencia

    ACTIVE_NOT_RECRUITING

    Valencia, Spain

  • Hospital Beata María Ana

    RECRUITING

    Madrid, Spain

  • Hospital Cachoeiro de Itapemirim

    NOT_YET_RECRUITING

    Cachoeiro de Itapemirim, Brazil

  • Hospital Clínic i Provincial de Barcelona

    RECRUITING

    Barcelona, Spain

  • Hospital Clínico Universitario Lozano Blesa

    RECRUITING

    Zaragoza, Spain

  • Hospital Clínico Universitario Virgen de la Arrixaca

    RECRUITING

    Murcia, Spain

  • Hospital Clínico Universitario de Valencia

    RECRUITING

    Valencia, Spain

  • Hospital General Universitario Dr. Balmis (Alicante)

    RECRUITING

    Alicante, Spain

  • Hospital Provincial de Castellón

    RECRUITING

    Castellon, Spain

  • Hospital Quirónsalud Sagrado Corazón

    RECRUITING

    Seville, Spain

  • Hospital San Carlos

    RECRUITING

    Madrid, Spain

  • Hospital San Pedro de Alcántara

    RECRUITING

    Cáceres, Spain

  • Hospital Universitari Dexeus

    RECRUITING

    Barcelona, Barcelona, Spain

  • Hospital Universitari Sant Joan de Reus

    RECRUITING

    Tarragona, Spain

  • Hospital Universitari Son Espases

    RECRUITING

    Palma de Mallorca, Spain

  • Hospital Universitari Vall D'Hebron

    RECRUITING

    Barcelona, Spain

  • Hospital Universitario Arnau de Vilanova de Lleida

    RECRUITING

    Lleida, Spain

  • Hospital Universitario Clínico San Cecilio de Granada

    RECRUITING

    Granada, Spain

  • Hospital Universitario Doce de Octubre

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Insular de Gran Canaria

    RECRUITING

    Las Palmas de Gran Canaria, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, Spain

  • Hospital Universitario La Ribera - Alzira

    RECRUITING

    Valencia, Spain

  • Hospital Universitario Marqués de Valdecilla

    RECRUITING

    Valdecilla, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, Spain

  • Hospital Universitario San Juan de Alicante

    RECRUITING

    Alicante, Spain

  • Hospital Universitario Sanchinarro-START-CIOCC

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, Spain

  • Hospital Universitario Virgen del Rocío

    RECRUITING

    Seville, Spain

  • Hospital Universitario de Basurto

    RECRUITING

    Bilbao, Spain

  • Hospital Universitario de Burgos

    RECRUITING

    Burgos, Spain

  • Hospital Universitario de Canarias

    RECRUITING

    Santa Cruz de Tenerife, Spain

  • Hospital Universitario de Elche

    RECRUITING

    Elche, Spain

  • Hospital Universitario de León

    RECRUITING

    León, Spain

  • Hospital del Mar

    RECRUITING

    Barcelona, Spain

  • Hospital prive des Cotes d'Amor

    RECRUITING

    Plérin, France

  • Hospitalario Universitario de Navarra

    RECRUITING

    Pamplona, Spain

  • Hämatologie-Onkologie im Zentrum MVZ GmbH

    NOT_YET_RECRUITING

    Augsburg, Germany

  • IRCCS Ospedale Policlinico San Martino

    NOT_YET_RECRUITING

    Genova, Italy

  • IRCCS San Gerardo

    NOT_YET_RECRUITING

    Monza, Italy

  • IUCT Oncopole

    RECRUITING

    Toulouse, France

  • Institut Bergonié Bordeaux

    NOT_YET_RECRUITING

    Bordeaux, France

  • Institut Català d' Oncologia Badalona (ICO)

    RECRUITING

    Badalona, Spain

  • Institut Paoli Calmettes

    NOT_YET_RECRUITING

    Marseille, France

  • Institute de Cancerologie de Lorraine - Nancy

    RECRUITING

    Vandœuvre-lès-Nancy, France

  • Instituto Europeo di Oncologia

    RECRUITING

    Milan, Italy

  • Klinikum Worms - Frauenklinik

    RECRUITING

    Worms, Germany

  • MD Anderson Cancer Center Madrid

    RECRUITING

    Madrid, Spain

  • MVZ II der Niels Stensen Kliniken

    RECRUITING

    Georgsmarienhütte, Germany

  • MVZ Klinikum Aschaffenburg

    NOT_YET_RECRUITING

    Aschaffenburg, Germany

  • Masaryk Memorial Cancer Institute

    RECRUITING

    Brno, Czechia

  • Medical University of Vienna

    NOT_YET_RECRUITING

    Vienna, Austria

  • Medizinische Universität Innsbruck

    RECRUITING

    Innsbruck, Austria

  • Metropolitan General Hospital 4th department

    RECRUITING

    Athens, Greece

  • Metropolitan Hospital Greece 1st department

    RECRUITING

    Piraeus, Greece

  • Motol University Hospital

    RECRUITING

    Prague, Czechia

  • Multiscan Nemocnice Horovice

    RECRUITING

    Hořovice, Czechia

  • NOB Ondina

    NOT_YET_RECRUITING

    Salvador, Brazil

  • Oncologia Medica AUSL Piacenza

    RECRUITING

    Piacenza, Italy

  • Ordensklinikum Linz Barmherzige Schwestern

    RECRUITING

    Linz, Austria

  • Ordination Priv.-Doz. Dr. Michael Hubalek

    RECRUITING

    Schwaz, Austria

  • Ospedali Riuniti Livorno

    RECRUITING

    Livorno, Italy

  • Policlinico A. Gemelli IRCCS

    NOT_YET_RECRUITING

    Roma, Italy

  • Polyclinique Bordeaux Nord Aquitaine

    RECRUITING

    Bordeau, France

  • Royal Cornwall Hospital NHS Trust

    RECRUITING

    Truro, United Kingdom

  • Royal Surrey County Hospital

    RECRUITING

    Surrey Quays, United Kingdom

  • Städtisches Klinikum Dessau

    NOT_YET_RECRUITING

    Dessau, Germany

  • Tacchini Instituto de Pesquisa

    NOT_YET_RECRUITING

    Bento Gonçalves, Brazil

  • Tomas Bata Regional Hospital in Zlin

    RECRUITING

    Zlín, Czechia

  • UPCO - Hospital de Clinicas de Porto Alegre

    NOT_YET_RECRUITING

    Porto Alegre, Brazil

  • University General Hospital Alexandroupoli

    RECRUITING

    Alexandroupoli, Greece

  • University General Hospital of Heraklion

    RECRUITING

    Heraklion, Greece

  • University General Hospital of Larissa

    RECRUITING

    Larissa, Greece

  • University Hospital Olomouc

    NOT_YET_RECRUITING

    Olomouc, Czechia

  • Universitätsklinikum Dusseldorf

    NOT_YET_RECRUITING

    Düsseldorf, Germany

  • Universitätsklinikum Essen

    NOT_YET_RECRUITING

    Essen, Germany

  • Western General Hospital

    NOT_YET_RECRUITING

    Edinburgh, United Kingdom

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