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neoAGORA: Exploring Clinical Utility of Serial Liquid Biopsy (ctDNA) in Patients With Early-Stage Breast Cancer
Sponsor: Spanish Breast Cancer Research Group
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.
Official title: neoAGORA: A Prospective Observational Study to Explore the Clinical Utility of Serial Liquid Biopsy in Patients With Early-stage Breast Cancer Receiving Neoadjuvant Therapy.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2026-08
Completion Date
2033-08
Last Updated
2026-07-22
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (10)
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Universitario Donostia
San Sebastián, Guipúzcoa, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Spain
Hospital Clínico Universitario San Carlos
Madrid, Madrid, Spain
Hospital Clínico Universitario Virgen De la Victoria
Málaga, Málaga, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, Spain
Hospital Universitario Virgen del Rocío
Seville, Sevilla, Spain
Hospital Universitario de Toledo
Toledo, Toledo, Spain
Instituto Valenciano de Oncologia
Valencia, Valencia, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain