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AzTrials

ER-positive Breast CancerPhase 3TREAT ctDNANCT05512364

Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)

A Phase 3 study testing Elacestrant, Tamoxifen and Letrozole 2.5mg in people with ER-positive Breast Cancer and HER2-negative Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 113 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

This is an international, multi-center, randomised, open label, superiority phase III trial of elacestrant vs standard endocrine therapy in patients with ER+/HER2- breast cancer and ctDNA relapse. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Elacestrant, Tamoxifen and Letrozole 2.5mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
113 sitesin 12 countries
Study dates
15 Dec 2023to 1 Nov 2035
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.
  • 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

Who cannot join

None listed.

Trial locations and contacts

113 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

EORTC HQ contact

+32 2 774 16 11

eortc@eortc.org

113 sites in 12 countries

Germany21 sites, 21 recruiting

  • Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH

    Aachen, 52074

    Recruiting

  • Gemeinschaftspraxis Augsburg

    Augsburg, 86150

    Recruiting

  • Evangelisches Krankenhaus -Bergisch Gladbach

    Bergisch Gladbach, 51465

    Recruiting

  • Marienhospital Bottrop gGmbH

    Bottrop, 46236

    Recruiting

  • Hamatologische Onkologische Praxis Im Medicum

    Bremen, 28209

    Recruiting

  • St Elisabeth-Krankenhaus

    Cologne, 50935

    Recruiting

  • Universitaetsklinikum Carl Gustav Carus (TUD)

    Dresden, 01307

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625

    Recruiting

  • Gemeinschaftspraxis Dr. Pourfard / Dr. Uleer

    Hildesheim, 31134

    Recruiting

  • Klinikum Kassel Gmbh

    Kassel, 34125

    Recruiting

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

    Leer, 26789

    Recruiting

  • Busch MCZ GmbH

    Mühlhausen, 99974

    Recruiting

  • Klinikum rechts der Isar München

    München

    Recruiting

  • Klinikum Nuernberg- Standort Nord

    Nuremberg, 90419

    Recruiting

  • Klinikum Ernst von Bergmann gemeinnützige GmbH

    Potsdam, 14467

    Recruiting

  • Mathias Spital Rheine

    Rheine

    Recruiting

  • Universitaetsklinikum Tuebingen-calwerstrasse

    Tübingen, 72076

    Recruiting

  • Universitaetsklinikum Ulm-Michelsberg

    Ulm, 89075

    Recruiting

  • GRN Klinik Weinheim

    Weinheim

    Recruiting

  • Rems-Murr-Kliniken gGmbH

    Winnenden

    Recruiting

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

    Wuppertal, 42283

    Recruiting

Other trials in Germany

Italy21 sites, 21 recruiting

  • Centro Di Riferimento Oncologico

    Aviano, 33081

    Recruiting

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

    Recruiting

  • AUSL della Romagna- - Ospedale Cervesi di Cattolica

    Cattolica

    Recruiting

  • Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134

    Recruiting

  • IRCCS Azienda Policlinico San Martino

    Genova, 16132

    Recruiting

  • Azienda USL IRCCS Di Reggio Emilia Guastalla

    Guastalla, 42016

    Recruiting

  • Ospedale Alessandro Manzoni

    Lecco, 23900

    Recruiting

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

    Legnano, 37045

    Recruiting

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

    Meldola, 47014

    Recruiting

  • Instituto Europeo di Oncologia

    Milan

    Recruiting

  • Azienda Ospedaliero - Universitaria Policlinico di Modena

    Modena

    Recruiting

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

    Monserrato, 09042

    Recruiting

  • Azienda Ospedaliera Universitaria "Federico II"

    Naples, 80131

    Recruiting

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, 43126

    Recruiting

  • Istituti Clinici Scientifici Maugeri

    Pavia, 27100

    Recruiting

  • San Maria della Misericordia Hospital

    Perugia, 06129

    Recruiting

  • Ospedale P. Pederzoli Casa Di Cura Privata

    Peschiera del Garda

    Recruiting

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56126

    Recruiting

  • Azienda USL IRCCS Di Reggio Emilia - Maria Nuova

    Reggio Emilia, 42100

    Recruiting

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

    Rimini, 47923

    Recruiting

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

    Rimini

    Recruiting

Other trials in Italy

Spain20 sites, 20 recruiting

  • Hospital General Universitario Doctor Balmis

    Alicante, 03010

    Recruiting

  • Hospital Universitario De Cruces

    Barakaldo, 48903

    Recruiting

  • Hospital Clinico Universitario - Virgen De La Arrixaca

    El Palmar, 30120

    Recruiting

  • ICO Girona - Hospital Doctor Josep Trueta

    Girona, 17007

    Recruiting

  • Hospital Universitario Virgen De Las Nieves

    Granada, 18014

    Recruiting

  • Hospital Universitario Clinico San Cecilio

    Granada, 18016

    Recruiting

  • ICO L'Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 08908

    Recruiting

  • Hospital Universitari Arnau De Vilanova

    Lleida, 25196

    Recruiting

  • Hospital Universitario 12 De Octubre

    Madrid, 28041

    Recruiting

  • Hospitales HM Sanchinarro-CIOCC

    Madrid, 28050

    Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid

    Recruiting

  • Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada

    Manresa, 08242

    Recruiting

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07010

    Recruiting

  • Hospital Universitario de Navarra

    Pamplona, 31008

    Recruiting

  • Hospital Sant Joan de Reus

    Reus, 43204

    Recruiting

  • Hospital Quironsalud Sagrado Corazon

    Seville, 41013

    Recruiting

  • University Hospital Virgen del Rocio

    Seville, 41013

    Recruiting

  • Hospital Universitario Virgen De La Macarena

    Seville, 41071

    Recruiting

  • Hospital Clinico Universitario De Valencia

    Valencia, 46010

    Recruiting

  • Hospital Universitario Y Politecnico La Fe

    Valencia, 46026

    Recruiting

Other trials in Spain

France16 sites, 16 recruiting

  • Clinique Belharra-Ramsay Sante

    Bayonne, 64100

    Recruiting

  • Centre de Radiotherapie Pierre Curie

    Beuvry, 62660

    Recruiting

  • Centre Hospitalier - Boulogne Sur Mer

    Boulogne-sur-Mer, 62321

    Recruiting

  • CHU de Lyon - Hopital Femme Mere Enfant

    Bron, 69677

    Recruiting

  • Centre Hospitalier Dr Techer

    Calais, 62107

    Recruiting

  • Societe de Recherche Oncologique Clinique 37

    Chambray-lès-Tours, 31170

    Recruiting

  • Hopital de Douai- Centre Leonard de Vinci

    Dechy, 59187

    Recruiting

  • Institut de Cancerologie de Bourgogne

    Dijon, 21000

    Recruiting

  • CHU de Limoges - Hopital Dupuytren

    Limoges, 87042

    Recruiting

  • CHU de Lyon - Hopital De La Croix Rousse

    Lyon, 69004

    Recruiting

  • CHU de Lyon - Hopital de la Croix Rousse

    Lyon

    Recruiting

  • Polyclinique De Gentilly - Centre d'Oncologie

    Nancy, 54100

    Recruiting

  • Institut Curie - Hopital de Paris

    Paris

    Recruiting

  • CHU de Lyon - Hopital Lyon Sud

    Pierre-Bénite, 69495

    Recruiting

  • Institut Curie - l'Hopital de St Cloud

    Saint-Cloud, 92210

    Recruiting

  • CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole

    Toulouse, 31059

    Recruiting

Other trials in France

Belgium10 sites, 10 recruiting

  • Institut Jules Bordet

    Anderlecht, 1070

    Recruiting

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

    Recruiting

  • Hopital Universitaire Brugmann

    Brussels

    Recruiting

  • Grand Hopital de Charleroi - Site Notre Dame

    Charleroi, 6000

    Recruiting

  • CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont

    Haine-Saint-Paul, 7100

    Recruiting

  • AZ Groeninge Kortrijk - Campus Kennedylaan

    Kortrijk, 8500

    Recruiting

  • U.Z. Leuven - Campus Gasthuisberg

    Leuven, 3000

    Recruiting

  • CHU Site Sainte-Elisabeth-UCL Namur

    Namur, 5000

    Recruiting

  • AZ Delta - Campus Rumbeke

    Roeselare, 8800

    Recruiting

  • Centre Hospitalier Regional Verviers

    Verviers, 4800

    Recruiting

Other trials in Belgium

Netherlands7 sites, 7 recruiting

  • Flevoziekenhuis Stichting

    Almere Stad, 1315 RA

    Recruiting

  • Amsterdam UMC - locatie VUMC

    Amsterdam, 1081 HV

    Recruiting

  • Rijnstate Hospital

    Arnhem, 6815

    Recruiting

  • Haaglanden Medisch Centrum

    Leidschendam, 2262 BA

    Recruiting

  • Ikazia Ziekenhuis

    Rotterdam, 3083

    Recruiting

  • Sint Antonius - St Antonius Ziekenhuis Utrecht

    Utrecht, 3543

    Recruiting

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

    Venlo, 5912

    Recruiting

Other trials in Netherlands

Ireland5 sites, 5 recruiting

  • Mater Private Hospital

    Dublin, D07 WKW8

    Recruiting

  • St. James'S Hospital

    Dublin, D08 NHY1

    Recruiting

  • Beacon Hospital

    Dublin, D18 AK68

    Recruiting

  • Mater Misericordia University Hospital

    Dublin

    Recruiting

  • University Hospital Waterford

    Waterford

    Recruiting

Other trials in Ireland

Greece3 sites, 3 recruiting

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

    Athens, 15123

    Recruiting

  • General University Hospital of Larissa

    Larissa, 41110

    Recruiting

  • Agios Loukas Clinic (St Lukes)

    Thessaloniki

    Recruiting

Other trials in Greece

Portugal3 sites, 3 recruiting

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

    Lisbon, 1649-028

    Recruiting

  • Hospital CUF Tejo

    Lisbon

    Recruiting

  • Centro Hospitalar Vila Nova Gaia/Espinho

    Vila Nova de Gaia

    Recruiting

Other trials in Portugal

Sweden3 sites, 3 recruiting

  • Sodra Alvsborgs Sjukhus - Vastra Gotalandsregionen

    Borås, 50182

    Recruiting

  • Skane University Hospital

    Lund

    Recruiting

  • Karolinska University Hospital, location Solna

    Stockholm, 17164

    Recruiting

Other trials in Sweden

Cyprus2 sites, 2 recruiting

  • German Oncology Center

    Limassol, 4108

    Recruiting

  • Bank Of Cyprus Oncology Centre

    Stróvolos, 2006

    Recruiting

Other trials in Cyprus

Switzerland2 sites, 2 recruiting

  • Kantonsspital Frauenfeld- Breast Unit Thurgau

    Frauenfeld, 8500

    Recruiting

  • Buergerspital Solothurn -Brustzentrum

    Solothurn, 4500

    Recruiting

Other trials in Switzerland

About this study

Official title: Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse

This is an international, multi-center, randomised, open label, superiority phase III trial of elacestrant vs standard endocrine therapy in patients with ER+/HER2- breast cancer and ctDNA relapse.

During the ctDNA screening phase, patients will be tested at different timepoints to detect the presence of ctDNA in their blood.

Patients who are found to be ctDNA-positive and have no evidence of distant metastasis, will be randomised 1:1 between standard endocrine treatment (the same they were receiving when tested ctDNA positive) versus elacestrant, provided they meet all eligibility criteria. After completion of the protocol treatment period, treatment will be left at the discretion of the treating physician.

Read the detailed description

International, multi-center, randomised, open label, superiority phase III trial of elacestrant vs standard endocrine therapy in patients with ER+/HER2- breast cancer and ctDNA relapse.

  1. ctDNA screening phase: After verification of the eligibility criteria for screening, patients will enter the ctDNA screening phase of the study in which plasma samples will be collected and tested with ctDNA assay to detect the presence of ctDNA. The test will be performed every 6 months from study entry until the end of accrual (approximately 5.7 years). During the screening phase, patients will be treated with standard adjuvant endocrine therapy [either tamoxifen or an aromatase inhibitor (exemestane, anastrozole or letrozole)] and followed-up as per standard of care. The outcome of the serial ctDNA assessments performed during the screening phase will be disclosed to investigators. Patients who are found to be ctDNA-negative at the end of the screening period will not be followed further in this study. Patients who are found to be ctDNA-positive at one of the screening time points will undergo an imaging work-up to assess the presence of distant metastases. Patients for whom the imaging work-up confirms no evidence of distant metastases or locoregional recurrence will be eligible for the randomised phase of the study provided they meet all other eligibility criteria. Patients for whom the imaging work-up shows evidence of distant metastases or locoregional recurrence will be excluded.
  2. Randomised trial:

Patients will be randomised 1:1 within 4 weeks from the date of ctDNA detection (i.e., the date on which the results of the test are received) between standard endocrine treatment (the same they were receiving when tested ctDNA positive) versus elacestrant.

In the absence of a withdrawal criteria, treatment in both arms will be administered for:

  • For patients on ET between 1 to 5 years (12 to 60 months) at the time of randomisation: 2 to 6 years (allowing for 7 years of ET at the end of the study treatment).
  • For patients on ET between 5 to 7.5 years (60 to 90 months) at the time of randomisation: 2 years.

After completion of the protocol treatment period, treatment will be left at the discretion of the treating physician.

Patients in both arms will undergo intensive follow-up with ctDNA tests at week 4 and week 16 after randomisation and every 16 weeks thereafter for a maximum of 3 years (36 months or 156 weeks) to assess ctDNA kinetics. In addition, the occurrence of distant metastases, locoregional recurrences and second cancers will be assessed via yearly mammograms and bone scans and 16-weekly CT scans thorax/abdomen for a maximum of 3 years after randomisation. Afterwards, follow-up will continue as per standard of care. All randomised patients will be followed-up until 3 years after the enrolment of the last patient.

End of study:

End of study occurs when all the following criteria have been satisfied:

All patients have completed their end of study visit. If a patient discontinues the follow-up due to withdrawal of consent, loss to follow-up, or death, the end of study participation is defined as the time point when one of these events occurred The trial is mature for all analyses defined in the protocol and the database has been cleaned and frozen for these analyses.

Being tested
Elacestrant, Tamoxifen, Letrozole 2.5mg, Anastrozole 1mg, Exemestane 25 MG
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElacestrantDrug

    400mg QD orally on a continuous dosing schedule

  • TamoxifenDrug

    20 mg QD orally on a continuous dosing schedule

  • Letrozole 2.5mgDrug

    2.5 mg QD orally on a continuous dosing schedule

  • Anastrozole 1mgDrug

    1 mg QD orally on a continuous dosing schedule

  • Exemestane 25 MGDrug

    25 mg QD orally on a continuous dosing schedule

Study groups in NCT05512364
Study groupRoleWhat they receive
Experimental armExperimentalelacestrant 400 mg/day orally once daily on a continuous dosing schedule
Receives: Drug: Elacestrant
Control armActive comparatorstandard endocrine treatment - the same they were receiving at the time of ctDNA detection
Receives: Drug: Tamoxifen; Drug: Letrozole 2.5mg; Drug: Anastrozole 1mg; Drug: Exemestane 25 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distant metastasis free survival (DMFS)

    Distant metastasis free survival (DMFS) defined as the time from randomisation until first distant metastatic recurrence or death from any cause, whichever occurs first

    Measured: Final DFMS will be 6.25 years after the first patient randomised.

Secondary outcomes (7)

  1. Invasive disease-free survival (iDFS)

    According to the STEEP criteria, it's defined as the time between the date of randomisation and the date of the first occurrence of one of the following events: loco-regional disease recurrence, distant metastasis, invasive contralateral breast cancer, invasive non-breast second cancer, or date of death from any cause

    Measured: Through study completion, up to 11.7 years

  2. Relapse-free survival (RFS)

    Relapse-free survival (RFS) rate according to the STEEP criteria, including locoregional recurrence, distant metastasis, deaths from any cause as events

    Measured: Through study completion, up to 11.7 years

  3. Overall survival rate

    Overall survival rate

    • Safety including but not limited to all adverse events, serious adverse events, laboratory abnormalities graded according to CTCAE version 5.0

    Measured: Through study completion, up to 11.7 years

  4. Adverse events

    Safety including but not limited to all adverse events, serious adverse events, laboratory abnormalities graded according to CTCAE version 5.0

    Measured: as of randomization until 30 days after administration of the last dose of protocol treatment.

  5. Health Related Quality of Life QLQ-C30

    European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30). This is a patient-reported questionnaire composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100.A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    Assessments will be performed at 21 days before randomisation, 4 weeks, 16 weeks, 32 weeks, 48 weeks, 64 weeks, and 80 weeks after randomisation using the following measures: QLQ-C30

    Measured: weeks 4, 16, 32, 48, 64 and 80

  6. Health Related Quality of Life EORTC IL146

    Health-related quality of life (HRQoL) is a secondary endpoint in this trial. HRQoL assessment aims at

    1. establishing the patient-reported tolerability profile in each treatment arm.
    2. comparing the patient-reported benefit between the two treatment arms.

    Assessments will be performed at 21 days before randomisation, 4 weeks, 16 weeks, 32 weeks, 48 weeks, 64 weeks, and 80 weeks after randomisation using the following measures: EORTC IL146.

    Measured: weeks 4, 16, 32, 48, 64 and 80

  7. Health Related Quality of Life QLQ-BR42

    Health-related quality of life (HRQoL) is a secondary endpoint in this trial. HRQoL assessment aims at

    1. establishing the patient-reported tolerability profile in each treatment arm.
    2. comparing the patient-reported benefit between the two treatment arms.

    Assessments will be performed at 21 days before randomisation, 4 weeks, 16 weeks, 32 weeks, 48 weeks, 64 weeks, and 80 weeksafter randomisation using the following measures:QLQ-BR42

    Measured: weeks 4, 16, 32, 48, 64 and 80

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2022
  2. Study start15 Dec 2023
  3. Primary completion1 Nov 2032 (estimated)
  4. Study completion1 Nov 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05512364
Sponsor's protocol ID
EORTC-2129-BCG
Acronym
TREAT ctDNA
Status last verified
Oct 2026
First submitted
22 Aug 2022
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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