Spots Global Cancer Trial Database for Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)
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Trial Identification
Brief Title: Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)
Official Title: Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse
Study ID: NCT05512364
Study Description
Brief 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. 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Institut Jules Bordet, Anderlecht, , Belgium
AZ KLINA Brasschaat, Brasschaat, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Grand Hopital de Charleroi - Site Notre Dame, Charleroi, , Belgium
Pole Hospitalier Jolimont - Hopital Jolimont, Haine-Saint-Paul, , Belgium
AZ Groeninge Kortrijk - Campus Kennedylaan, Kortrijk, , Belgium
U.Z. Leuven - Campus Gasthuisberg, Leuven, , Belgium
AZ Delta - Campus Menen, Menen, , Belgium
CHU Site Sainte-Elisabeth-UCL Namur, Namur, , Belgium
AZ Delta - Campus Rumbeke, Roeselare, , Belgium
AZ Delta Torhout, Torhout, , Belgium
AZ Turnhout - Campus Sint Elisabeth, Turnhout, , Belgium
Centre Hospitalier Regional Verviers, Verviers, , Belgium
CH de La Cote Basque - Saint Leon, Bayonne, , France
Centre de Radiotherapie Pierre Curie, Beuvry, , France
Centre Hospitalier - Boulogne Sur Mer, Boulogne-sur-Mer, , France
CHU de Lyon - Hopital Femme Mere Enfant, Bron, , France
Centre d'Oncology Radiotherapie (ROC-37), Chambray-lès-Tours, , France
CHU de Lyon - Hopital De La Croix Rousse, Lyon, , France
Centre d'Oncologie de Gentilly, Nancy, , France
CHU de Lyon - Hopital Lyon Sud, Pierre-Bénite, , France
Institut de Cancerologie Strasbourg Europe, Strasbourg, , France
CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole, Toulouse, , France
MVM MbH -Onkologie UnterEms, Leer-Papenburg-Emden, Leer, , Germany
Universitaetsklinikum Ulm-Michelsberg, Ulm, , Germany
Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke, Wuppertal, , Germany
Beacon Hospital, Dublin, , Ireland
Mater Misericordia University Hospital, Dublin, , Ireland
St James's Hospital, Dublin, , Ireland
University Hospital Waterford, Waterford, , Ireland
Centro Di Riferimento Oncologico, Aviano, , Italy
Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, , Italy
Azienda Ospedaliero-Universitaria Careggi, Firenze, , Italy
Azienda USL IRCCS Di Reggio Emilia Guastalla, Guastalla, , Italy
Ospedale Alessandro Manzoni, Lecco, , Italy
Mater Salutis Hospital, Legnano, , Italy
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, , Italy
Cliniche Humanitas Gavazzeni, Milano, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Istituti Clinici Scientifici Maugeri, Pavia, , Italy
San Maria della Misericordia Hospital, Perugia, , Italy
Azienda USL IRCCS Di Reggio Emilia - Maria Nuova, Reggio Emilia, , Italy
Contact Details
Name: Michail Ignatiadis
Affiliation: Institut Jules Bordet, Belgium
Role: STUDY_CHAIR
Name: Emmanouil Saloustros
Affiliation: General University Hospital of Larissa, Greece
Role: STUDY_CHAIR
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