JOURNAL ONKOLOGIE – STUDIE

TREAT ctDNA

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05512364

Studienbeginn:
Dezember 2023

Letztes Update:
24.01.2024

Wirkstoff:
Elacestrant, Tamoxifen, Letrozole 2.5mg, Anastrozole 1mg, Exemestane 25 MG

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC

Collaborator:
Breast International Group, Menarini Group,

Studienleiter

Michail Ignatiadis
Study Chair
Institut Jules Bordet, Belgium

Emmanouil Saloustros
Study Chair
General University Hospital of Larissa, Greece

Kontakt

EORTC HQ
Kontakt:
Phone: +32 2 774 16 11
E-Mail: eortc@eortc.org» Kontaktdaten anzeigen

Studienlocations
(3 von 42)

MVM MbH -Onkologie UnterEms, Leer-Papenburg-Emden
Leer
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps

Universitaetsklinikum Ulm-Michelsberg
Ulm
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps

Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke
Wuppertal
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps

Institut Jules Bordet
Anderlecht
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Daniela Wayllace
Phone: 0032 2 541 3216
E-Mail: m.wayllaceriguera@hubruxelles.be

Sylvie Bartholomeus
Phone: 0032 2 541 3234
E-Mail: sylvie.bartholomeus@hubruxelles.be» Ansprechpartner anzeigen

AZ KLINA Brasschaat
Brasschaat
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Elise Vrebosch
Phone: 0032 3650 5399
E-Mail: elise.vrebosch@klina.be

Marthe Bosque
Phone: 0032 3650 5378
E-Mail: marthe.bosque@klina.be» Ansprechpartner anzeigen

Cliniques Universitaires Saint-Luc
Brussels
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Nathalie Blondeel
Phone: 0032 276 442 14
E-Mail: nathalie.blondeel@uclouvain.be

Elodie Villar
Phone: 0032 276 479 38
E-Mail: elodie.villar@uclouvain.be» Ansprechpartner anzeigen

Grand Hopital de Charleroi - Site Notre Dame
Charleroi
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Stephanie Adam
Phone: 0032 71 104762
E-Mail: stephanie.adam@ghdc.be

Pauline Isenborghs
Phone: 0032 71 104763
E-Mail: pauline.isenborghs@ghdc.be» Ansprechpartner anzeigen

Pole Hospitalier Jolimont - Hopital Jolimont
Haine-Saint-Paul
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Thecle Fourneaux
Phone: 0032 64/23.46.62
E-Mail: thecle.fourneaux@jolimont.be

Alexandra Sperone
Phone: 0032 64/23.19.63
E-Mail: Alexandra.sperone@helora.be» Ansprechpartner anzeigen

AZ Groeninge Kortrijk - Campus Kennedylaan
Kortrijk
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Ellen Callens
Phone: 003256633943
E-Mail: ellen.callens@azgroeninge.be

Charlotte Vankeirsbilk
Phone: 003256633942
E-Mail: charlotte.vankeirsbilck@azgroeninge.be» Ansprechpartner anzeigen

U.Z. Leuven - Campus Gasthuisberg
Leuven
BelgiumNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Joke Deroover
Phone: 0032 16 34 74 19
E-Mail: joke.deroover@uzleuven.be

Beatrijs Steelandt
Phone: 0032 16 34 59 07
E-Mail: Beatrijs.steelandt@uzleuven.be» Ansprechpartner anzeigen

AZ Delta - Campus Menen
Menen
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Rina Talpe
Phone: +3251237511
E-Mail: rina.talpe@azdelta.be

Laura Tanghe
Phone: +3251237325
E-Mail: laura.tanghe@azdelta.be» Ansprechpartner anzeigen

CHU Site Sainte-Elisabeth-UCL Namur
Namur
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Caroline Yague
Phone: 003281720843
E-Mail: caroline.yaguesanz@chuuclnamur.uclouvain.be

Monique Gilsoul
Phone: 003281720548
E-Mail: monique.gilsoul@chuuclnamur.uclouvain.be» Ansprechpartner anzeigen

AZ Delta - Campus Rumbeke
Roeselare
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Rina Talpe
Phone: 0032 5123 7511
E-Mail: rina.talpe@azdelta.be

Laura Tanghe
Phone: 0032 5123 7325
E-Mail: laura.tanghe@azdelta.be» Ansprechpartner anzeigen

AZ Delta Torhout
Torhout
BelgiumRekrutierend» Google-Maps
Ansprechpartner:
Laura Tanghe
Phone: +3251237325
E-Mail: laura.tanghe@azdelta.be

Rina Talpe
Phone: +3251237511
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AZ Turnhout - Campus Sint Elisabeth
Turnhout
BelgiumNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Nel Bovin
Phone: 003214406908
E-Mail: nel.bovin@azturnhout.be

Sarah Geentjens
Phone: 003214406902
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Centre Hospitalier Regional Verviers
Verviers
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Ansprechpartner:
Valerie Graindorge
Phone: 0032 8721 2589
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Charlotte Trussart
Phone: 0032 8721 2768
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CH de La Cote Basque - Saint Leon
Bayonne
FranceNoch nicht rekrutierend» Google-Maps

Centre de Radiotherapie Pierre Curie
Beuvry
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Centre Hospitalier - Boulogne Sur Mer
Boulogne-sur-Mer
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CHU de Lyon - Hopital Femme Mere Enfant
Bron
FranceNoch nicht rekrutierend» Google-Maps

Centre d'Oncology Radiotherapie (ROC-37)
Chambray-lès-Tours
FranceNoch nicht rekrutierend» Google-Maps

CHU de Lyon - Hopital De La Croix Rousse
Lyon
FranceNoch nicht rekrutierend» Google-Maps

Centre d'Oncologie de Gentilly
Nancy
FranceNoch nicht rekrutierend» Google-Maps

CHU de Lyon - Hopital Lyon Sud
Pierre-Bénite
FranceNoch nicht rekrutierend» Google-Maps

Institut de Cancerologie Strasbourg Europe
Strasbourg
FranceNoch nicht rekrutierend» Google-Maps

CHU de Toulouse - Institut Claudius Regaud - IUCT oncopole
Toulouse
FranceNoch nicht rekrutierend» Google-Maps

Beacon Hospital
Dublin
IrelandNoch nicht rekrutierend» Google-Maps

Mater Misericordia University Hospital
Dublin
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St James's Hospital
Dublin
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University Hospital Waterford
Waterford
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Centro Di Riferimento Oncologico
Aviano
ItalyNoch nicht rekrutierend» Google-Maps

Azienda Ospedaliera Papa Giovanni XXIII
Bergamo
ItalyNoch nicht rekrutierend» Google-Maps

Azienda Ospedaliero-Universitaria Careggi
Firenze
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Guastalla
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Ospedale Alessandro Manzoni
Lecco
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Mater Salutis Hospital
Legnano
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IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola
ItalyNoch nicht rekrutierend» Google-Maps

Cliniche Humanitas Gavazzeni
Milano
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Istituto Europeo di Oncologia
Milano
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Istituti Clinici Scientifici Maugeri
Pavia
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San Maria della Misericordia Hospital
Perugia
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Azienda USL IRCCS Di Reggio Emilia - Maria Nuova
Reggio Emilia
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Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Distant metastasis free survival (DMFS) (Time Frame - 5.2 years after first patient screened):
DMFS defined as the time from randomisation until first distant metastatic recurrence or death from any cause, whichever occurs first

Secondary outcome:

1. ctDNA elimination rate at month 1 (Time Frame - at month 1):
defined as the proportion of randomised patients who had a negative ctDNA test result at month 1

Studien-Arme

Experimental: Experimental arm
elacestrant 400 mg/day orally once daily on a continuous dosing schedule
Active Comparator: Control arm
standard endocrine treatment - the same they were receiving at the time of ctDNA detection

Geprüfte Regime

Elacestrant:
400mg QD orally on a continuous dosing schedule
Tamoxifen:
20 mg QD orally on a continuous dosing schedule
Letrozole 2.5mg:
2.5 mg QD orally on a continuous dosing schedule
Anastrozole 1mg:
1 mg QD orally on a continuous dosing schedule
Exemestane 25 MG:
25 mg QD orally on a continuous dosing schedule

Quelle: ClinicalTrials.gov

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

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