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

HER2 Negative 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

Inclusion criteria for surveillance phase:
Signed informed consent form (ICF) prior to participation in any Studyrelated activities.
Male or female patients aged 18 years or older.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

For full eligibility, visit ClinicalTrials.gov.

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