neoAGORA: Exploring Clinical Utility of Serial Liquid Biopsy (ctDNA) in Patients With Early-Stage Breast Cancer

Study acronym: neoAGORA
StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. Notable Recruitment opened
    • Start date changed from estimate of Aug 2026 to Sep 30, 2026
    • Eligibility criteria expanded, about 16 words
    • Site details revised at 10 of 10 sites
  2. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
The goal of this observational study is to explore the utility of analytical techniques that enable the study of small amounts of tumor-derived material circulating in the blood, such as fragments of circulating tumor DNA (also known as ctDNA), cells, or other particles. This type of sample is generally referred to as a liquid biopsy, and its analysis is a minimally invasive test, as it only requires the collection of blood samples. The study includes women and men with early-stage breast cancer (EBC) who are about to start neoadjuvant treatment (treatment given before surgery). The main questions it aims to answer are: * Can liquid biopsy analyses (ctDNA) provide additional information about the type of tumor before treatment starts? * Can these analyses help to detect early whether the tumor is responding to treatment? * Can these tests identify if any cancer remains after neoadjuvant treatment or after surgery? * Is this information related to the risk of the cancer coming back? * Can these analyses, when performed during follow-up, help detect cancer recurrence earlier? Participants will: * Continue receiving standard medical care for their breast cancer, including neoadjuvant therapy and surgery. * Provide blood samples at different time points during treatment and follow-up. * Provide residual tumor samples from the routine clinical care.
Trial Details
NCT Number NCT07718841
Lead Sponsor Spanish Breast Cancer Research Group
Conditions
(from sponsor)
Early Breast Cancer (EBC)
Related terms Breast Neoplasms
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov