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

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.

Conditions

• ER-positive Breast Cancer
• HER2-negative Breast Cancer
• Stage IIB Breast Cancer
• Stage III Breast Cancer

Interventions

DRUG

Elacestrant

400mg QD orally on a continuous dosing schedule

DRUG

Tamoxifen

20 mg QD orally on a continuous dosing schedule

DRUG

Letrozole 2.5mg

2.5 mg QD orally on a continuous dosing schedule

DRUG

Anastrozole 1mg

1 mg QD orally on a continuous dosing schedule

DRUG

Exemestane 25 MG

25 mg QD orally on a continuous dosing schedule

Sponsors & Collaborators

• Menarini Group

  collaborator INDUSTRY

• Natera, Inc.

  collaborator INDUSTRY

• Borstkanker Onderzoek Groep

  collaborator NETWORK

• Cancer Trials Ireland

  collaborator NETWORK

• SOLTI Breast Cancer Research Group

  collaborator OTHER

• ETOP IBCSG Partners Foundation

  collaborator NETWORK

• SUCCESS

  collaborator UNKNOWN

• Hellenic Cooperative Oncology Group

  collaborator OTHER

• Hellenic Oncology Research Group

  collaborator OTHER

• Swedish Breast Cancer Group

  collaborator OTHER

• European Organisation for Research and Treatment of Cancer - EORTC

  lead NETWORK

Principal Investigators

• Michail Ignatiadis · Institut Jules Bordet, Belgium

• Emmanouil Saloustros · General University Hospital of Larissa, Greece

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-15

Primary Completion

2032-11-01

Completion

2035-11-01

Countries

• Belgium
• Cyprus
• France
• Germany
• Greece
• Ireland
• Italy
• Netherlands
• Portugal
• Spain
• Sweden
• Switzerland

Study Locations