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Blood test catches cancer early: new drug aims to stop spread

NCT ID NCT05512364

Disease control Sponsor: European Organisation for Research and Treatment of Cancer - EORTC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Updated 5 times

Summary

This Phase 3 trial tests whether elacestrant, a new hormone therapy, can prevent distant metastasis better than standard hormone therapies in 220 patients with ER+/HER2- breast cancer whose blood tests show signs of cancer DNA (ctDNA) but no visible spread. Participants are randomly assigned to elacestrant or their current therapy. The goal is to see if elacestrant extends the time before cancer spreads or causes death.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Elacestrant (a hormone therapy drug)
What this could lead to
If successful, this could offer a more effective treatment option to delay or prevent distant metastasis in patients with early signs of relapse detected by a blood test.
What could go wrong
This is a Phase 3 trial, but it's still experimental. Elacestrant may not prove superior to existing therapies, and side effects like nausea or muscle pain are possible.

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 220 people

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

Started

Dec 2023

Expected to finish

Nov 2035

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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: 1. ctDNA screening phase: Main inclusion criteria: • Female (both pre- and postmenopausal) or male patients with histologically confirmed ER positive (regardless of PR), HER2 negative breast cancer, according to local pathologist: * ER-positive defined as ≥ 10% of cells staining positive for ER or Allred proportion score ≥3 * HER2-negative defined as a score of 0, 1+ by immunohistochemistry (IHC) or a negative in situ hybridization (ISH) based on single-probe average HER2 copy number, as per American Society of Clinical Oncology guidelines * Intermediate to high risk of recurrence after definitive treatment for early breast cancer, defined as: FOR PATIENTS TREATED WITH PRIMARY SURGERY: * Any patient with ≥ 4 positive axillary lymph nodes (stage pN2-3). * 1-3 positive axillary lymph nodes (stage pN1) and either: * Tumour size ≥ 5 cm or/and * Histologic grade 3 or/and * Ki67≥20% or/and * High genomic risk defined as Oncotype Dx Recurrence Score \>=26, Mammaprint high risk, Prosigna score \>40 or EPclin risk score \>=4.0. * Negative axillary lymph nodes (stage pN0) and tumour size ≥ 2 cm and either * Histologic grade 3 a or/and * Ki67≥20% and/or * High genomic risk defined as Oncotype Dx Recurrence Score \>=26, Mammaprint high risk, Prosigna score \>60 or EPclin risk score \>=4.0. FOR PATIENTS TREATED WITH NEOADJUVANT SYSTEMIC TREATMENT FOLLOWED BY SURGERY: * Patient may have received neoadjuvant endocrine therapy or neoadjuvant chemotherapy provided that: * The initial tumour and/or the tumour after surgery meet the criteria above defined for patients treated with primary surgery or the initial tumour was staged as cT4anyN and * There is no pathological complete response, defined as no invasive disease in the breast and axilla (ypT0/is ypN0). * Age ≥18 years * Patients must have received at least 1 year and up to 7.5 years of ET and planned to continue adjuvant ET during ctDNA screening phase * Previous adjuvant CDK4/6 inhibitor or PARP-inhibitor treatment is allowed provided it is completed * Invasive multicentric / multifocal disease is allowed provided that all the tested foci are ER+ HER2-. A sample from the highest-risk one, according to the investigator decision based on the size and grade, should be sent to Natera to build the patient ctDNA assay. * Available tumour sample from resected or biopsied tissue, with a tumour content of ≥20% (30% preferred) either before or after macro dissection (if performed) and a cell viability of a minimum 100 cells. * Core Needle Biopsies (CNB): recommended minimum of four (4) cores per block * Fine Needle Aspirates (FNA) are not accepted * The following sample types are acceptable: * 6-10 unstained slides (charged and unbaked) of 10μm each (or 12-19 unstained slides at 5 μm each), PLUS one contiguous H\&E slide. Minimum total tissue thickness must be 60μm OR * FFPE tissue block with 25mm2 minimum surface area * Written informed consent must be given according to ICH/GCP, and national/local regulations. Main exclusion criteria: * Suspected recurrent disease or known conflicts with the inclusion and exclusion criteria for the randomised trial * Prior treatment with any SERD or investigational ER antagonist * Previous history of invasive breast cancer * Previous history of any other malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ. * Previous history of bone marrow and/or organ transplant * Bilateral invasive breast cancer * Participation in another clinical study, with the exception of the SURVIVE study and observational (non-interventional) and non-drug intervention clinical studies. Note: patients participating in interventional studies may participate once they enter the follow-up period of the study * Blood transfusion within 3 months prior to registration or during the screening. 2. Randomised trial: Main inclusion criteria: * ctDNA positive according to the Signatera ctDNA assay (main study ctDNA test) or other ctDNA assay approved for diagnostic purposes. * Patients must meet the eligibility criteria for the screening phase, with the exception of the tissue sample requirements. * Patients must receive adjuvant ET at the time of the ctDNA positive test * Absence of locoregional and/or metastatic disease and/or new malignancy, as investigated by: * Mammogram (unilateral in case of mastectomy; not required in patients having undergone bilateral mastectomy) NOTE: if local investigator plans to use MRIs instead of mammograms during the study, MRI will have to be performed at baseline. * CT thorax and abdomen/pelvis with IV contrast. In case of any contra-indications (medical or regulatory): CT thorax without contrast + MRI abdomen/pelvis. * Technetium-99m bone scintigraphy * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 * Adequate organ function * Women of childbearing potential (WOCBP) must have a negative highly sensitive serum or urine pregnancy test within 7 days prior to randomisation. Main exclusion criteria: * Any unresolved toxic effect of prior therapies or surgical procedures of Grade ≥ 2 according to Common Terminology Criteria of Adverse Events (CTCAE) v5.0, with the exception of alopecia, peripheral neuropathy and other toxicities not considered a safety risk for the participant at investigator's discretion * Unable or unwilling to avoid over-the-counter medications, dietary/herbal supplements, and/or foods that are moderate/strong inhibitors or inducers of CYP3A4 activity * Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications * Any of the following cardiovascular disorders within 3 months before enrolment: * myocardial infarction * stroke * severe/unstable angina * symptomatic cardiac arrhythmia * prolonged QTcF ≥ Grade 3 (i.e., \> 500 msec) * heart failure ≥ Class III as defined by the New York Heart Association (NYHA) guidelines * CTCAE version 5.0 grade 3 or 4 dyslipidemia at the time of screening, defined as cholesterol\>400 mg/dL or \>10.34 mmol/L and/or triglycerides\>500 mg/dL or \>5.7 mmol/L. * Child-Pugh Score greater than Class A * Uncontrolled significant active infections (≥ grade 3 according to CTCAE version 5), including active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency Virus (HIV) * Coagulopathy or any history of coagulopathy within the past 6 months, including history of deep vein thrombosis or pulmonary embolism

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Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

ER-positive breast cancer HER2-negative breast cancer Stage IIB breast cancer Stage III breast cancer

How to take part

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

  1. The places running it

    112 sites in 12 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • AUSL Romagna - AUSL Della Romagna - Infermi Hospital -Rimini

    RECRUITING

    Rimini, 47923, Italy

  • AUSL Romagna - AUSL Della Romagna - Infermi Hospital -Rimini

    RECRUITING

    Rimini, Italy

  • AZ Delta - Campus Rumbeke

    RECRUITING

    Roeselare, 8800, Belgium

  • AZ Groeninge Kortrijk - Campus Kennedylaan

    RECRUITING

    Kortrijk, 8500, Belgium

  • Agios Loukas Clinic (St Lukes)

    RECRUITING

    Thessaloniki, Greece

  • Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada

    RECRUITING

    Manresa, 08242, Spain

  • Amsterdam UMC - locatie VUMC

    RECRUITING

    Amsterdam, 1081 HV, Netherlands

  • Azienda Ospedaliera Papa Giovanni XXIII

    RECRUITING

    Bergamo, 24127, Italy

  • Azienda Ospedaliera Universitaria "Federico II"

    RECRUITING

    Naples, 80131, Italy

  • Azienda Ospedaliera Universitaria Pisana

    RECRUITING

    Pisa, 56126, Italy

  • Azienda Ospedaliero - Universitaria Policlinico di Modena

    RECRUITING

    Modena, Italy

  • Azienda Ospedaliero-Universitaria di Parma

    RECRUITING

    Parma, 43126, Italy

  • Azienda USL IRCCS Di Reggio Emilia - Maria Nuova

    RECRUITING

    Reggio Emilia, 42100, Italy

  • Azienda USL IRCCS Di Reggio Emilia Guastalla

    RECRUITING

    Guastalla, 42016, Italy

  • Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital

    RECRUITING

    Legnano, 37045, Italy

  • Bank Of Cyprus Oncology Centre

    RECRUITING

    Stróvolos, 2006, Cyprus

  • Beacon Hospital

    RECRUITING

    Dublin, D18 AK68, Ireland

  • Buergerspital Solothurn -Brustzentrum

    RECRUITING

    Solothurn, 4500, Switzerland

  • Busch MCZ GmbH

    RECRUITING

    Mühlhausen, 99974, Germany

  • CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont

    RECRUITING

    Haine-Saint-Paul, 7100, Belgium

  • CHU Site Sainte-Elisabeth-UCL Namur

    RECRUITING

    Namur, 5000, Belgium

  • CHU de Limoges - Hopital Dupuytren

    RECRUITING

    Limoges, 87042, France

  • CHU de Lyon - Hopital De La Croix Rousse

    RECRUITING

    Lyon, 69004, France

  • CHU de Lyon - Hopital Femme Mere Enfant

    RECRUITING

    Bron, 69677, France

  • CHU de Lyon - Hopital Lyon Sud

    RECRUITING

    Pierre-Bénite, 69495, France

  • CHU de Lyon - Hopital de la Croix Rousse

    RECRUITING

    Lyon, France

  • CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole

    RECRUITING

    Toulouse, 31059, France

  • Centre Hospitalier - Boulogne Sur Mer

    RECRUITING

    Boulogne-sur-Mer, 62321, France

  • Centre Hospitalier Dr Techer

    RECRUITING

    Calais, 62107, France

  • Centre Hospitalier Regional Verviers

    RECRUITING

    Verviers, 4800, Belgium

  • Centre de Radiotherapie Pierre Curie

    RECRUITING

    Beuvry, 62660, France

  • Centro Di Riferimento Oncologico

    RECRUITING

    Aviano, 33081, Italy

  • Centro Hospitalar Universitario de Lisboa Norte - Centro Hospitalar Universitario Lisboa Norte - Hospital Sta. Maria

    RECRUITING

    Lisbon, 1649-028, Portugal

  • Centro Hospitalar Vila Nova Gaia/Espinho

    RECRUITING

    Vila Nova de Gaia, Portugal

  • Clinique Belharra-Ramsay Sante

    RECRUITING

    Bayonne, 64100, France

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Diagnostic & Therapeutic Center of Athens Hygeia Hospital S.A.

    RECRUITING

    Athens, 15123, Greece

  • Evangelisches Krankenhaus -Bergisch Gladbach

    RECRUITING

    Bergisch Gladbach, 51465, Germany

  • Flevoziekenhuis Stichting

    RECRUITING

    Almere Stad, 1315 RA, Netherlands

  • GRN Klinik Weinheim

    RECRUITING

    Weinheim, Germany

  • Gemeinschaftspraxis Augsburg

    RECRUITING

    Augsburg, 86150, Germany

  • Gemeinschaftspraxis Dr. Pourfard / Dr. Uleer

    RECRUITING

    Hildesheim, 31134, Germany

  • General University Hospital of Larissa

    RECRUITING

    Larissa, 41110, Greece

  • German Oncology Center

    RECRUITING

    Limassol, 4108, Cyprus

  • Grand Hopital de Charleroi - Site Notre Dame

    RECRUITING

    Charleroi, 6000, Belgium

  • HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke

    RECRUITING

    Wuppertal, 42283, Germany

  • Haaglanden Medisch Centrum

    RECRUITING

    Leidschendam, 2262 BA, Netherlands

  • Hamatologische Onkologische Praxis Im Medicum

    RECRUITING

    Bremen, 28209, Germany

  • Hopital Universitaire Brugmann

    RECRUITING

    Brussels, Belgium

  • Hopital de Douai- Centre Leonard de Vinci

    RECRUITING

    Dechy, 59187, France

  • Hospital CUF Tejo

    RECRUITING

    Lisbon, Portugal

  • Hospital Clinico Universitario - Virgen De La Arrixaca

    RECRUITING

    El Palmar, 30120, Spain

  • Hospital Clinico Universitario De Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital General Universitario Doctor Balmis

    RECRUITING

    Alicante, 03010, Spain

  • Hospital Quironsalud Sagrado Corazon

    RECRUITING

    Seville, 41013, Spain

  • Hospital Sant Joan de Reus

    RECRUITING

    Reus, 43204, Spain

  • Hospital Universitari Arnau De Vilanova

    RECRUITING

    Lleida, 25196, Spain

  • Hospital Universitari Son Espases

    RECRUITING

    Palma de Mallorca, 07010, Spain

  • Hospital Universitario 12 De Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Clinico San Cecilio

    RECRUITING

    Granada, 18016, Spain

  • Hospital Universitario De Cruces

    RECRUITING

    Barakaldo, 48903, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Virgen De La Macarena

    RECRUITING

    Seville, 41071, Spain

  • Hospital Universitario Virgen De Las Nieves

    RECRUITING

    Granada, 18014, Spain

  • Hospital Universitario Y Politecnico La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Hospitales HM Sanchinarro-CIOCC

    RECRUITING

    Madrid, 28050, Spain

  • ICO Girona - Hospital Doctor Josep Trueta

    RECRUITING

    Girona, 17007, Spain

  • ICO L'Hospitalet - Hospital Duran i Reynals

    RECRUITING

    L'Hospitalet de Llobregat, 08908, Spain

  • IRCCS Azienda Policlinico San Martino

    RECRUITING

    Genova, 16132, Italy

  • IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

    RECRUITING

    Meldola, 47014, Italy

  • Ikazia Ziekenhuis

    RECRUITING

    Rotterdam, 3083, Netherlands

  • Institut Curie - Hopital de Paris

    RECRUITING

    Paris, France

  • Institut Curie - l'Hopital de St Cloud

    RECRUITING

    Saint-Cloud, 92210, France

  • Institut Jules Bordet

    RECRUITING

    Anderlecht, 1070, Belgium

  • Institut de Cancerologie de Bourgogne

    RECRUITING

    Dijon, 21000, France

  • Instituto Europeo di Oncologia

    RECRUITING

    Milan, Italy

  • Istituti Clinici Scientifici Maugeri

    RECRUITING

    Pavia, 27100, Italy

  • Kantonsspital Frauenfeld- Breast Unit Thurgau

    RECRUITING

    Frauenfeld, 8500, Switzerland

  • Karolinska University Hospital, location Solna

    RECRUITING

    Stockholm, 17164, Sweden

  • Klinikum Ernst von Bergmann gemeinnützige GmbH

    RECRUITING

    Potsdam, 14467, Germany

  • Klinikum Kassel Gmbh

    RECRUITING

    Kassel, 34125, Germany

  • Klinikum Nuernberg- Standort Nord

    RECRUITING

    Nuremberg, 90419, Germany

  • Klinikum rechts der Isar München

    RECRUITING

    München, Germany

  • MVM MbH -Onkologie UnterEms, Leer-Papenburg-Emden

    RECRUITING

    Leer, 26789, Germany

  • Marienhospital Bottrop gGmbH

    RECRUITING

    Bottrop, 46236, Germany

  • Mater Misericordia University Hospital

    RECRUITING

    Dublin, Ireland

  • Mater Private Hospital

    RECRUITING

    Dublin, D07 WKW8, Ireland

  • Mathias Spital Rheine

    RECRUITING

    Rheine, Germany

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, 30625, Germany

  • Ospedale Alessandro Manzoni

    RECRUITING

    Lecco, 23900, Italy

  • Ospedale P. Pederzoli Casa Di Cura Privata

    RECRUITING

    Peschiera del Garda, Italy

  • Polyclinique De Gentilly - Centre d'Oncologie

    RECRUITING

    Nancy, 54100, France

  • Rems-Murr-Kliniken gGmbH

    RECRUITING

    Winnenden, Germany

  • Rijnstate Hospital

    RECRUITING

    Arnhem, 6815, Netherlands

  • San Maria della Misericordia Hospital

    RECRUITING

    Perugia, 06129, Italy

  • Sint Antonius - St Antonius Ziekenhuis Utrecht

    RECRUITING

    Utrecht, 3543, Netherlands

  • Skane University Hospital

    RECRUITING

    Lund, Sweden

  • Societe de Recherche Oncologique Clinique 37

    RECRUITING

    Chambray-lès-Tours, 31170, France

  • Sodra Alvsborgs Sjukhus - Vastra Gotalandsregionen

    RECRUITING

    Borås, 50182, Sweden

  • St Elisabeth-Krankenhaus

    RECRUITING

    Cologne, 50935, Germany

  • St. James'S Hospital

    RECRUITING

    Dublin, D08 NHY1, Ireland

  • U.Z. Leuven - Campus Gasthuisberg

    RECRUITING

    Leuven, 3000, Belgium

  • Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi

    RECRUITING

    Florence, 50134, Italy

  • Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH

    RECRUITING

    Aachen, 52074, Germany

  • Universitaetsklinikum Carl Gustav Carus (TUD)

    RECRUITING

    Dresden, 01307, Germany

  • Universitaetsklinikum Tuebingen-calwerstrasse

    RECRUITING

    Tübingen, 72076, Germany

  • Universitaetsklinikum Ulm-Michelsberg

    RECRUITING

    Ulm, 89075, Germany

  • University Hospital Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • University Hospital Waterford

    RECRUITING

    Waterford, Ireland

  • University Hospital of Cagliari Duilio Casula Hospital Unit (Policlinico)

    RECRUITING

    Monserrato, 09042, Italy

  • VieCuri - Medisch Centrum voor Noord-Limburg - Locatie Venlo

    RECRUITING

    Venlo, 5912, Netherlands

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