Not Yet RecruitingNot Applicable

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

Spain300 participantsStarted 2026-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Written informed consent prior to any specific study procedure.
. Patients with willingness and ability to comply with study procedures.
. Patients (women and men) ≥18 years of age.
. Patients with a first diagnosis of the UICC (Union for International Cancer Control) stage I-III primary invasive BC whose tumors are of any of the following subtypes:
. Patients that are scheduled to receive NAT as determined by the treating physician according to standard clinical practice.
. Archival Formalin-Fixed, Paraffin-Embedded (FFPE) sample of the primary tumor must be available to analyze tumor-informed ctDNA assays.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prognostic and Predictive Value of ctDNA in Patients Receiving NAT

Timeframe: From Study Start Date to Primary Completion Date (25 months).

Trial details

NCT IDNCT07718841

SponsorSpanish Breast Cancer Research Group

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-09

Contact for this trial

Study Project Manager

+34916592870 inicio_ensayos@geicam.org

View on ClinicalTrials.gov More Early Breast Cancer (EBC) trials