Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)
NCT ID: NCT05512364
Last Updated: 2025-08-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE3
Total Enrollment
220 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-12-15
Study Completion Date
2035-11-01
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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ER-positive Breast Cancer
HER2-negative Breast Cancer
Stage IIB Breast Cancer
Stage III Breast Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Experimental arm
elacestrant 400 mg/day orally once daily on a continuous dosing schedule
Group Type
EXPERIMENTAL
Elacestrant
Intervention Type
DRUG
400mg QD orally on a continuous dosing schedule
Control arm
standard endocrine treatment - the same they were receiving at the time of ctDNA detection
Group Type
ACTIVE_COMPARATOR
Tamoxifen
Intervention Type
DRUG
20 mg QD orally on a continuous dosing schedule
Letrozole 2.5mg
Intervention Type
DRUG
2.5 mg QD orally on a continuous dosing schedule
Anastrozole 1mg
Intervention Type
DRUG
1 mg QD orally on a continuous dosing schedule
Exemestane 25 MG
Intervention Type
DRUG
25 mg QD orally on a continuous dosing schedule
Interventions
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Elacestrant
400mg QD orally on a continuous dosing schedule
Intervention Type
DRUG
Tamoxifen
20 mg QD orally on a continuous dosing schedule
Intervention Type
DRUG
Letrozole 2.5mg
2.5 mg QD orally on a continuous dosing schedule
Intervention Type
DRUG
Anastrozole 1mg
1 mg QD orally on a continuous dosing schedule
Intervention Type
DRUG
Exemestane 25 MG
25 mg QD orally on a continuous dosing schedule
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. ctDNA screening phase:
• 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 ≥ 5 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.
* 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.
• 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 ≥ 5 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.
* 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.
Exclusion Criteria
* 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 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:
* 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
* 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
* 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 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:
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Sponsor Role
lead
Breast International Group
OTHER
Sponsor Role
collaborator
Menarini Group
INDUSTRY
Sponsor Role
collaborator
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Michail Ignatiadis
Role: STUDY_CHAIR
Institut Jules Bordet, Belgium
Emmanouil Saloustros
Role: STUDY_CHAIR
General University Hospital of Larissa, Greece
Locations
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Institut Jules Bordet
Anderlecht, , Belgium
Site Status
RECRUITING
AZ KLINA
Brasschaat, , Belgium
Site Status
RECRUITING
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Site Status
RECRUITING
Grand Hopital de Charleroi - Site Notre Dame
Charleroi, , Belgium
Site Status
RECRUITING
CHU Helora Pole Hospitalier Jolimont - Hopital Jolimont
Haine-Saint-Paul, , Belgium
Site Status
RECRUITING
AZ Groeninge Kortrijk - Campus Kennedylaan
Kortrijk, , Belgium
Site Status
RECRUITING
U.Z. Leuven - Campus Gasthuisberg
Leuven, , Belgium
Site Status
RECRUITING
CHU Site Sainte-Elisabeth-UCL Namur
Namur, , Belgium
Site Status
RECRUITING
AZ Delta - Campus Rumbeke
Roeselare, , Belgium
Site Status
RECRUITING
AZ Turnhout - Campus Sint Elisabeth
Turnhout, , Belgium
Site Status
RECRUITING
Centre Hospitalier Regional Verviers
Verviers, , Belgium
Site Status
RECRUITING
German Oncology Center
Limassol, , Cyprus
Site Status
RECRUITING
Bank Of Cyprus Oncology Centre
Stróvolos, , Cyprus
Site Status
RECRUITING
CH de La Cote Basque - Saint Leon
Bayonne, , France
Site Status
RECRUITING
Clinique Belharra-Ramsay Sante
Bayonne, , France
Site Status
RECRUITING
Centre de Radiotherapie Pierre Curie
Beuvry, , France
Site Status
RECRUITING
Centre Hospitalier - Boulogne Sur Mer
Boulogne-sur-Mer, , France
Site Status
RECRUITING
CHU de Lyon - Hopital Femme Mere Enfant
Bron, , France
Site Status
RECRUITING
Societe de Recherche Oncologique Clinique 37
Chambray-lès-Tours, , France
Site Status
RECRUITING
Hopital de Douai- Centre Leonard de Vinci
Dechy, , France
Site Status
RECRUITING
CHU de Limoges - Hopital Dupuytren
Limoges, , France
Site Status
RECRUITING
CHU de Lyon - Hopital De La Croix Rousse
Lyon, , France
Site Status
RECRUITING
Polyclinique De Gentilly - Centre d'Oncologie
Nancy, , France
Site Status
RECRUITING
CHU de Lyon - Hopital Lyon Sud
Pierre-Bénite, , France
Site Status
RECRUITING
Institut Curie - l'Hopital de St Cloud
Saint-Cloud, , France
Site Status
RECRUITING
CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole
Toulouse, , France
Site Status
RECRUITING
Universitaetsklinikum Aachen AOR - Medizinische Fakultaet der RWTH
Aachen, , Germany
Site Status
RECRUITING
Gemeinschaftspraxis Augsburg
Augsburg, , Germany
Site Status
RECRUITING
Evangelisches Krankenhaus -Bergisch Gladbach
Bergisch Gladbach, , Germany
Site Status
RECRUITING
Marienhospital Bottrop gGmbH
Bottrop, , Germany
Site Status
RECRUITING
Hamatologische Onkologische Praxis Im Medicum
Bremen, , Germany
Site Status
RECRUITING
St Elisabeth-Krankenhaus
Cologne, , Germany
Site Status
RECRUITING
Universitaetsklinikum Carl Gustav Carus (TUD)
Dresden, , Germany
Site Status
RECRUITING
Medizinische Hochschule Hannover
Hanover, , Germany
Site Status
RECRUITING
Gemeinschaftspraxis Dr. Pourfard / Dr. Uleer
Hildesheim, , Germany
Site Status
RECRUITING
Klinikum Kassel Gmbh
Kassel, , Germany
Site Status
RECRUITING
MVM MbH -Onkologie UnterEms, Leer-Papenburg-Emden
Leer, , Germany
Site Status
RECRUITING
Busch MCZ GmbH
Mühlhausen, , Germany
Site Status
RECRUITING
Klinikum Nuernberg- Standort Nord
Nuremberg, , Germany
Site Status
RECRUITING
Klinikum Ernst von Bergmann gemeinnützige GmbH
Potsdam, , Germany
Site Status
RECRUITING
Universitaetsklinikum Tuebingen-calwerstrasse
Tübingen, , Germany
Site Status
RECRUITING
Universitaetsklinikum Ulm-Michelsberg
Ulm, , Germany
Site Status
RECRUITING
HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke
Wuppertal, , Germany
Site Status
RECRUITING
Diagnostic & Therapeutic Center of Athens Hygeia Hospital S.A.
Athens, , Greece
Site Status
RECRUITING
General University Hospital of Larissa
Larissa, , Greece
Site Status
RECRUITING
Mater Private Hospital
Dublin, , Ireland
Site Status
RECRUITING
St. James'S Hospital
Dublin, , Ireland
Site Status
RECRUITING
Beacon Hospital
Dublin, , Ireland
Site Status
RECRUITING
Centro Di Riferimento Oncologico
Aviano, , Italy
Site Status
RECRUITING
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
Site Status
RECRUITING
Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Site Status
RECRUITING
IRCCS Azienda Policlinico San Martino
Genova, , Italy
Site Status
RECRUITING
Azienda USL IRCCS Di Reggio Emilia Guastalla
Guastalla, , Italy
Site Status
RECRUITING
Ospedale Alessandro Manzoni
Lecco, , Italy
Site Status
RECRUITING
Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital
Legnano, , Italy
Site Status
RECRUITING
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, , Italy
Site Status
RECRUITING
University Hospital of Cagliari Duilio Casula Hospital Unit (Policlinico)
Monserrato, , Italy
Site Status
RECRUITING
Azienda Ospedaliera Universitaria "Federico II"
Napoli, , Italy
Site Status
RECRUITING
Azienda Ospedaliero-Universitaria di Parma
Parma, , Italy
Site Status
RECRUITING
Istituti Clinici Scientifici Maugeri
Pavia, , Italy
Site Status
RECRUITING
San Maria della Misericordia Hospital
Perugia, , Italy
Site Status
RECRUITING
Azienda Ospedaliera Universitaria Pisana
Pisa, , Italy
Site Status
RECRUITING
Azienda USL IRCCS Di Reggio Emilia - Maria Nuova
Reggio Emilia, , Italy
Site Status
RECRUITING
AUSL Romagna - AUSL Della Romagna - Infermi Hospital -Rimini
Rimini, , Italy
Site Status
RECRUITING
Flevoziekenhuis Stichting
Almere Stad, , Netherlands
Site Status
RECRUITING
Amsterdam UMC - locatie VUMC
Amsterdam, , Netherlands
Site Status
RECRUITING
Rijnstate Hospital
Arnhem, , Netherlands
Site Status
RECRUITING
Haaglanden Medisch Centrum
Leidschendam, , Netherlands
Site Status
RECRUITING
Ikazia Ziekenhuis
Rotterdam, , Netherlands
Site Status
RECRUITING
Sint Antonius - St Antonius Ziekenhuis Utrecht
Utrecht, , Netherlands
Site Status
RECRUITING
VieCuri - Medisch Centrum voor Noord-Limburg - Locatie Venlo
Venlo, , Netherlands
Site Status
RECRUITING
Hospital General Universitario Doctor Balmis
Alicante, , Spain
Site Status
RECRUITING
Hospital Universitario De Cruces
Barakaldo, , Spain
Site Status
RECRUITING
Hospital Clinico Universitario - Virgen De La Arrixaca
El Palmar, , Spain
Site Status
RECRUITING
ICO Girona - Hospital Doctor Josep Trueta
Girona, , Spain
Site Status
RECRUITING
Hospital Universitario Virgen De Las Nieves
Granada, , Spain
Site Status
RECRUITING
Hospital Universitario Clinico San Cecilio
Granada, , Spain
Site Status
RECRUITING
ICO L'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, , Spain
Site Status
RECRUITING
Hospital Universitari Arnau De Vilanova
Lleida, , Spain
Site Status
RECRUITING
Hospital Universitario 12 De Octubre
Madrid, , Spain
Site Status
RECRUITING
Hospitales HM Sanchinarro-CIOCC
Madrid, , Spain
Site Status
RECRUITING
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Manresa, , Spain
Site Status
RECRUITING
Hospital Universitari Son Espases
Palma de Mallorca, , Spain
Site Status
RECRUITING
Hospital Universitario de Navarra
Pamplona, , Spain
Site Status
RECRUITING
Hospital Sant Joan de Reus
Reus, , Spain
Site Status
RECRUITING
Hospital Quironsalud Sagrado Corazon
Seville, , Spain
Site Status
RECRUITING
University Hospital Virgen del Rocio
Seville, , Spain
Site Status
RECRUITING
Hospital Universitario Virgen De La Macarena
Seville, , Spain
Site Status
RECRUITING
Hospital Clinico Universitario De Valencia
Valencia, , Spain
Site Status
RECRUITING
Hospital Universitario Y Politecnico La Fe
Valencia, , Spain
Site Status
RECRUITING
Sodra Alvsborgs Sjukhus - Vastra Gotalandsregionen
Borås, , Sweden
Site Status
RECRUITING
Karolinska University Hospital, location Solna
Stockholm, , Sweden
Site Status
RECRUITING
Kantonsspital Frauenfeld- Breast Unit Thurgau
Frauenfeld, , Switzerland
Site Status
RECRUITING
Buergerspital Solothurn -Brustzentrum
Solothurn, , Switzerland
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Belgium
Cyprus
France
Germany
Greece
Ireland
Italy
Netherlands
Spain
Sweden
Switzerland
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EORTC-2129-BCG
Identifier Type: -
Identifier Source: org_study_id
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