Trial Title:
Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)
NCT ID:
NCT05512364
Condition:
ER-positive Breast Cancer
HER2-negative Breast Cancer
Stage IIB Breast Cancer
Stage III Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Tamoxifen
Letrozole
Anastrozole
Exemestane
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Elacestrant
Description:
400mg QD orally on a continuous dosing schedule
Arm group label:
Experimental arm
Intervention type:
Drug
Intervention name:
Tamoxifen
Description:
20 mg QD orally on a continuous dosing schedule
Arm group label:
Control arm
Intervention type:
Drug
Intervention name:
Letrozole 2.5mg
Description:
2.5 mg QD orally on a continuous dosing schedule
Arm group label:
Control arm
Intervention type:
Drug
Intervention name:
Anastrozole 1mg
Description:
1 mg QD orally on a continuous dosing schedule
Arm group label:
Control arm
Intervention type:
Drug
Intervention name:
Exemestane 25 MG
Description:
25 mg QD orally on a continuous dosing schedule
Arm group label:
Control arm
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ctDNA screening phase
- Female 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
- 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
- Elevated risk of recurrence after definitive treatment for early breast cancer,
defined as either:
- Stage IIB or stage III disease according to the 8th edition of the UICC
TNM classification and completion of adjuvant chemotherapy, OR
- Completion of at least 4 cycles of neoadjuvant chemotherapy and residual
tumour at surgery of ≥ 1cm (≥ypT1c) or axillary node + (ypN+)
- Pre- or postmenopausal status (for female patients).
- Age ≥18 years
- Patients must have received at least 2 years and up to 7 years of ET
- Previous adjuvant CDK4/6 inhibitor or PARP-inhibitor treatment is allowed if
completed at least 12 months before registration
- Patients with multifocal tumours are allowed provided all foci are biopsied and
are ER-positive and HER2-negative as defined above
- Available FFPE tumour block from the baseline biopsy or from surgical specimen
or at least 10 slides of 10μm and a tumour cellularity of at least 25%. For
patients with multifocal tumours, FFPE block or slides from the largest focus
is required.
- Written informed consent must be given according to ICH/GCP, and national/local
regulations.
- Randomised phase
- ctDNA positive according to the Signatera ctDNA assay
- Absence of locoregional and/or metastatic disease, as investigated by:
- Mammogram (unilateral in case of mastectomy; not required in patients
having undergone bilateral mastectomy)
- 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 3 days prior to randomisation.
Exclusion Criteria:
- ctDNA screening phase
- 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 of the cervix . Patients who have been disease free for more than 5 years
with low risk of relapse are allowed
- Bilateral breast cancer
- Participation in another clinical study, with the exception of the SURVIVE
study Note: patients participating in interventional studies may participate
once they enter the follow-up period of the study
- Randomised phase
- 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 prescription medications, 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:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Jules Bordet
Address:
City:
Anderlecht
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Daniela Wayllace
Phone:
0032 2 541 3216
Email:
m.wayllaceriguera@hubruxelles.be
Contact backup:
Last name:
Sylvie Bartholomeus
Phone:
0032 2 541 3234
Email:
sylvie.bartholomeus@hubruxelles.be
Investigator:
Last name:
Michail Ignatiadis
Email:
Principal Investigator
Facility:
Name:
AZ KLINA Brasschaat
Address:
City:
Brasschaat
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Elise Vrebosch
Phone:
0032 3650 5399
Email:
elise.vrebosch@klina.be
Contact backup:
Last name:
Marthe Bosque
Phone:
0032 3650 5378
Email:
marthe.bosque@klina.be
Investigator:
Last name:
Wim Demey
Email:
Principal Investigator
Investigator:
Last name:
Boudewijn Dullens
Email:
Sub-Investigator
Facility:
Name:
Cliniques Universitaires Saint-Luc
Address:
City:
Brussels
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Nathalie Blondeel
Phone:
0032 276 442 14
Email:
nathalie.blondeel@uclouvain.be
Contact backup:
Last name:
Elodie Villar
Phone:
0032 276 479 38
Email:
elodie.villar@uclouvain.be
Investigator:
Last name:
Cedric Van Marcke De Lummen
Email:
Principal Investigator
Facility:
Name:
Grand Hopital de Charleroi - Site Notre Dame
Address:
City:
Charleroi
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Stephanie Adam
Phone:
0032 71 104762
Email:
stephanie.adam@ghdc.be
Contact backup:
Last name:
Pauline Isenborghs
Phone:
0032 71 104763
Email:
pauline.isenborghs@ghdc.be
Investigator:
Last name:
Sarah Lefevre
Email:
Principal Investigator
Facility:
Name:
Pole Hospitalier Jolimont - Hopital Jolimont
Address:
City:
Haine-Saint-Paul
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Thecle Fourneaux
Phone:
0032 64/23.46.62
Email:
thecle.fourneaux@jolimont.be
Contact backup:
Last name:
Alexandra Sperone
Phone:
0032 64/23.19.63
Email:
Alexandra.sperone@helora.be
Investigator:
Last name:
Benedicte Petit
Email:
Principal Investigator
Investigator:
Last name:
Caterina Confente
Email:
Sub-Investigator
Facility:
Name:
AZ Groeninge Kortrijk - Campus Kennedylaan
Address:
City:
Kortrijk
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Ellen Callens
Phone:
003256633943
Email:
ellen.callens@azgroeninge.be
Contact backup:
Last name:
Charlotte Vankeirsbilk
Phone:
003256633942
Email:
charlotte.vankeirsbilck@azgroeninge.be
Investigator:
Last name:
Marianne Hanssens
Email:
Principal Investigator
Investigator:
Last name:
Sofie Demasure
Email:
Sub-Investigator
Facility:
Name:
U.Z. Leuven - Campus Gasthuisberg
Address:
City:
Leuven
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Joke Deroover
Phone:
0032 16 34 74 19
Email:
joke.deroover@uzleuven.be
Contact backup:
Last name:
Beatrijs Steelandt
Phone:
0032 16 34 59 07
Email:
Beatrijs.steelandt@uzleuven.be
Investigator:
Last name:
Patrick Neven
Email:
Principal Investigator
Facility:
Name:
AZ Delta - Campus Menen
Address:
City:
Menen
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Rina Talpe
Phone:
+3251237511
Email:
rina.talpe@azdelta.be
Contact backup:
Last name:
Laura Tanghe
Phone:
+3251237325
Email:
laura.tanghe@azdelta.be
Investigator:
Last name:
Barbara Busssels
Email:
Principal Investigator
Investigator:
Last name:
Karin Schotte
Email:
Sub-Investigator
Investigator:
Last name:
Barbara Stragier
Email:
Sub-Investigator
Investigator:
Last name:
Jan Demol
Email:
Sub-Investigator
Investigator:
Last name:
Tine Vanlancker
Email:
Sub-Investigator
Facility:
Name:
CHU Site Sainte-Elisabeth-UCL Namur
Address:
City:
Namur
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Caroline Yague
Phone:
003281720843
Email:
caroline.yaguesanz@chuuclnamur.uclouvain.be
Contact backup:
Last name:
Monique Gilsoul
Phone:
003281720548
Email:
monique.gilsoul@chuuclnamur.uclouvain.be
Investigator:
Last name:
Donnatienne Taylor
Email:
Principal Investigator
Investigator:
Last name:
Stephanie Henri
Email:
Sub-Investigator
Facility:
Name:
AZ Delta - Campus Rumbeke
Address:
City:
Roeselare
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Rina Talpe
Phone:
0032 5123 7511
Email:
rina.talpe@azdelta.be
Contact backup:
Last name:
Laura Tanghe
Phone:
0032 5123 7325
Email:
laura.tanghe@azdelta.be
Investigator:
Last name:
Barbara Busssels
Email:
Principal Investigator
Investigator:
Last name:
Barbara Stragier
Email:
Sub-Investigator
Investigator:
Last name:
Karin Schotte
Email:
Sub-Investigator
Investigator:
Last name:
Jan Demol
Email:
Sub-Investigator
Investigator:
Last name:
Tine Vanlancker
Email:
Sub-Investigator
Facility:
Name:
AZ Delta Torhout
Address:
City:
Torhout
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Laura Tanghe
Phone:
+3251237325
Email:
laura.tanghe@azdelta.be
Contact backup:
Last name:
Rina Talpe
Phone:
+3251237511
Email:
rina.talpe@azdelta.be
Investigator:
Last name:
Barbara Busssels
Email:
Principal Investigator
Investigator:
Last name:
Barbara Stragier
Email:
Sub-Investigator
Investigator:
Last name:
Karin Schotte
Email:
Sub-Investigator
Investigator:
Last name:
Jan Demol
Email:
Sub-Investigator
Investigator:
Last name:
Tine Vanlancker
Email:
Sub-Investigator
Facility:
Name:
AZ Turnhout - Campus Sint Elisabeth
Address:
City:
Turnhout
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Nel Bovin
Phone:
003214406908
Email:
nel.bovin@azturnhout.be
Contact backup:
Last name:
Sarah Geentjens
Phone:
003214406902
Email:
sarah.geentjens@azturnhout.be
Investigator:
Last name:
Inne Renders
Email:
Principal Investigator
Facility:
Name:
Centre Hospitalier Regional Verviers
Address:
City:
Verviers
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Valerie Graindorge
Phone:
0032 8721 2589
Email:
valerie.graindorge@chrverviers.be
Contact backup:
Last name:
Charlotte Trussart
Phone:
0032 8721 2768
Email:
charlotte.trussart@chrverviers.be
Investigator:
Last name:
Annelore Barbeaux
Email:
Principal Investigator
Facility:
Name:
CH de La Cote Basque - Saint Leon
Address:
City:
Bayonne
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Thomas Grellety
Email:
Principal Investigator
Facility:
Name:
Centre de Radiotherapie Pierre Curie
Address:
City:
Beuvry
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Jean-Briac Prevost
Email:
Principal Investigator
Facility:
Name:
Centre Hospitalier - Boulogne Sur Mer
Address:
City:
Boulogne-sur-Mer
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Abeer Najem
Email:
Principal Investigator
Facility:
Name:
CHU de Lyon - Hopital Femme Mere Enfant
Address:
City:
Bron
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
julien Perron
Email:
Principal Investigator
Facility:
Name:
Centre d'Oncology Radiotherapie (ROC-37)
Address:
City:
Chambray-lès-Tours
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Tévy San
Email:
Principal Investigator
Facility:
Name:
CHU de Lyon - Hopital De La Croix Rousse
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
julien Perron
Email:
Principal Investigator
Facility:
Name:
Centre d'Oncologie de Gentilly
Address:
City:
Nancy
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Dominique Spaeth
Email:
Principal Investigator
Facility:
Name:
CHU de Lyon - Hopital Lyon Sud
Address:
City:
Pierre-Bénite
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
julien Perron
Email:
Principal Investigator
Facility:
Name:
Institut de Cancerologie Strasbourg Europe
Address:
City:
Strasbourg
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Thierry Petit
Email:
Principal Investigator
Facility:
Name:
CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole
Address:
City:
Toulouse
Country:
France
Status:
Not yet recruiting
Investigator:
Last name:
Eleonora De Maio
Email:
Principal Investigator
Facility:
Name:
MVM MbH -Onkologie UnterEms, Leer-Papenburg-Emden
Address:
City:
Leer
Country:
Germany
Status:
Not yet recruiting
Investigator:
Last name:
Lothar Mueller
Email:
Principal Investigator
Facility:
Name:
Universitaetsklinikum Ulm-Michelsberg
Address:
City:
Ulm
Country:
Germany
Status:
Not yet recruiting
Investigator:
Last name:
Wolfgang Janni
Email:
Principal Investigator
Facility:
Name:
Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke
Address:
City:
Wuppertal
Country:
Germany
Status:
Not yet recruiting
Investigator:
Last name:
Vesna Bjelic-Radisic
Email:
Principal Investigator
Facility:
Name:
Beacon Hospital
Address:
City:
Dublin
Country:
Ireland
Status:
Not yet recruiting
Investigator:
Last name:
Lisa Prior
Email:
Principal Investigator
Facility:
Name:
Mater Misericordia University Hospital
Address:
City:
Dublin
Country:
Ireland
Status:
Not yet recruiting
Investigator:
Last name:
Geraldine Coyne O'Sullivan
Email:
Principal Investigator
Facility:
Name:
St James's Hospital
Address:
City:
Dublin
Country:
Ireland
Status:
Not yet recruiting
Investigator:
Last name:
Catherine Kelly
Email:
Principal Investigator
Facility:
Name:
University Hospital Waterford
Address:
City:
Waterford
Country:
Ireland
Status:
Not yet recruiting
Investigator:
Last name:
Ciara O'Connor
Email:
Principal Investigator
Facility:
Name:
Centro Di Riferimento Oncologico
Address:
City:
Aviano
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Fabio Puglisi
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Papa Giovanni XXIII
Address:
City:
Bergamo
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Paola Poletti
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliero-Universitaria Careggi
Address:
City:
Firenze
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Icro Meattini
Email:
Principal Investigator
Facility:
Name:
Azienda USL IRCCS Di Reggio Emilia Guastalla
Address:
City:
Guastalla
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Filippo Giovanardi
Email:
Principal Investigator
Facility:
Name:
Ospedale Alessandro Manzoni
Address:
City:
Lecco
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Federica Villa
Email:
Principal Investigator
Facility:
Name:
Mater Salutis Hospital
Address:
City:
Legnano
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Anna Mercanti
Email:
Principal Investigator
Facility:
Name:
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Address:
City:
Meldola
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Ugo De Giorgi
Email:
Principal Investigator
Facility:
Name:
Cliniche Humanitas Gavazzeni
Address:
City:
Milano
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Fabio Conforti
Email:
Principal Investigator
Facility:
Name:
Istituto Europeo di Oncologia
Address:
City:
Milano
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Giuseppe Curigliano
Email:
Principal Investigator
Facility:
Name:
Istituti Clinici Scientifici Maugeri
Address:
City:
Pavia
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Federico Sottotetti
Email:
Principal Investigator
Facility:
Name:
San Maria della Misericordia Hospital
Address:
City:
Perugia
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Anna Maria Mosconi
Email:
Principal Investigator
Facility:
Name:
Azienda USL IRCCS Di Reggio Emilia - Maria Nuova
Address:
City:
Reggio Emilia
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Filippo Giovanardi
Email:
Principal Investigator
Start date:
December 15, 2023
Completion date:
May 1, 2030
Lead sponsor:
Agency:
European Organisation for Research and Treatment of Cancer - EORTC
Agency class:
Other
Collaborator:
Agency:
Breast International Group
Agency class:
Other
Collaborator:
Agency:
Menarini Group
Agency class:
Industry
Source:
European Organisation for Research and Treatment of Cancer - EORTC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05512364
