A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population

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 obta

Trial Details

NCT ID
NCT05708235
Phase
PHASE2
Sponsor
MedSIR
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Giredestrant
  • Abemaciclib
  • Inavolisib
Locations (sample)
  • A Coruña, Spain|43.37135,-8.396
  • Alicante, Spain|38.34517,-0.48149
  • Alicante, Spain|38.34517,-0.48149
  • Alicante, Spain|38.34517,-0.48149
  • Barcelona, Spain|41.38879,2.15899

Key Eligibility Criteria

  • Signed surveillance phase ICF prior to participation in any Study-related activities.
  • Male or female participants aged 18 years or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Histologically proven primary HR-positive according to the updated American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP…

For full eligibility, visit ClinicalTrials.gov.

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