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

NCT07718841 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-07-22

No results posted yet for this study

Summary

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.

Conditions

  • Early Breast Cancer (EBC)

Interventions

OTHER

biological samples, images, and clinical data

This is an observational study in which clinical decisions concerning the optimum therapy for a particular patient are taken independently of, and prior to, offering the patient to participate in the study. The treating physician will make all treatment decisions according to his/her regular clinical practice independent of this study. The study will systematically collect and integrate biological samples, images, and clinical data in the neoadjuvant and follow-up period. Serial blood samples are collected for neoAGORA study align with blood extractions performed as part of the patient's standard clinical care and tumor samples are residual samples from clinical practice.

Sponsors & Collaborators

  • Spanish Breast Cancer Research Group

    lead OTHER

Principal Investigators

  • Study Director · Hospital Donostia

  • Study Director · Instituto Valenciano de Oncología

  • Study Director · Hospital Clínico Universitario San Carlos

  • Study Director · Hospital General Universitario Gregorio Marañon

  • Study Director · Hospital Clínico Universitario Virgen de la Victoria

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-09-30
Completion
2033-08-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07718841 on ClinicalTrials.gov