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TREAT ctDNA

Essai international, multicentrique, randomisé, de phase III en ouvert et de supériorité de l’élacestrant par rapport à l’endocrinothérapie standard chez les patients atteints d’un cancer du sein ER+/HER2- et d’une rechute selon l’ADNtc

Critères d'inclusion :

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
• 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+). Patients with only residual micrometastases (N1mic) or isolated tumour cells (ITCs) will not be eligible.
• Age ≥18 years
• Patients must have received at least 4.5 years and up to 7 years of ET and planned to continue adjuvant ET during ctDNA screening phase
• Previous adjuvant CDK4/6 inhibitor or PARP-inhibitor treatment is allowed
• Available FFPE tumour block with 25mm2 minimum surface from the baseline biopsy or from surgical specimen OR preferably 6-10 unstained slides of 10μm each (or 12-20 unstained slides at 5μm each) PLUS one H&E slide. Tumour cellularity must be ≥ 20% (preferably ≥30%).
Note: Sequencing of tumour tissue is necessary to build a patient specific ctDNA assay. Patients from whom tumour tissue is not available cannot be registered in the study
• Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations

Critères de non inclusion :

Suspected recurrent disease or known conflicts with the inclusion and exclusion criteria for the randomised trial

Version 3.0 38 13 October, 2023
• 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. Patients who have been disease free for more than 5 years with low risk of relapse are allowed
• Bilateral breast cancer
• Known hypersensitivity reaction to drugs chemically related to elacestrant or their excipients
• Participation in another clinical study, with the exception of the SURVIVE study and observational (non-interventional) clinical studies. Note: patients participating in interventional studies may participate once they enter the follow-up period of the study

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