- A PoC Study to Evaluate Treatments’ Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population — Recruiting • Phase II • Oncology • NCT05708235.
- What is being tested: A phase II study evaluating adjuvant treatment efficacy in HR-positive/HER2-negative early breast cancer by using circulating tumour DNA (ctDNA) as a minimal residual disease (MRD) biomarker to guide and monitor therapeutic response through serial blood sampling.
- Patient eligibility overview: The trial includes patients with HR-positive/HER2-negative early-stage breast cancer at higher risk of relapse who have undergone recent surgery, with eligibility stratified by baseline MRD status detected through ctDNA analysis.
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This trial is a multicenter, open-label, non-comparative, phase II, biomarker-driven adjuvant treatment study involving the periodic collection and analysis of blood samples from patients with HR-positive/HER2-negative early-stage BC at higher risk of relapse, who have undergone surgery within the previous five years, with no evidence of locoregional, contralateral, or distant disease. The study design is composed by an initial pre-screening phase, a molecular follow-up phase (ctDNA surveillance phase), and an interventional therapeutic phase (treatment phase). After informed consent is obtained, a total of 976 eligible patients will enter a ctDNA…
- Eligibility criteria for surveillance phase: Note: Participants who had not participated in the surveillance phase but have an additional positive ctDNA test will be eligible for direct-to-treatment phase entry if they fulfill all the matching eligibility requirements. Therefore, these participants will not need to meet all the eligibility criteria for the surveillance phase. Inclusion criteria (surveillance phase): 1. Signed surveillance phase ICF prior to participation in any Study-related activities. 2. Male or female participants aged 18 years or older. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 4. Histologically proven primary HR-positive according to the updated American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) 2020 guidelines and HER2-negative BC as per ASCO/CAP 2018 criteria based on local testing on the most recent analyzed biopsy.
- Participants with high-risk early-stage BC according to at least one of the following criteria: 1. If no previous neoadjuvant chemotherapy: i. pN2-N3, or ii. pN1 (including micrometastasis - pN1mi) if: 1. pT3/T4, or 2. pT2 and high genomic risk, and/or histological grade III, and/or Ki 67 ≥ 30%. b. If participants have received previous neoadjuvant chemotherapy, they must have had residual invasive disease defined as at least one of the following:…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.