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.
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.
Luminal: Hormonal Receptor(HR)-positive and HER2-negative.
Patients with stage IV BC.
Patients with previous anti-cancer treatment for the current BC.
Patients with diagnosis of any other invasive malignancy in the 5 prior years, unless the malignancy has been treated with curative intent and is considered at low risk of recurrence, with no evidence of active disease at study entry.
Patients with a diagnosis of bilateral or multifocal breast tumors with different HR or HER2 status.
The target population for inclusion in this study is BC patients scheduled to receive neoadjuvant treatment.
Cohort
Prospective
biological samples, images, and clinical data
Other interventionThis 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.
Prognostic and Predictive Value of ctDNA in Patients Receiving NAT
To evaluate the association between ctDNA detection, molecular profiling, and longitudinal ctDNA dynamics (at baseline, during NAT and pre-surgery) and efficacy outcomes. The ctDNA metrics and patterns assessed before surgery will be: * ctDNA status/levels and molecular profiling at baseline, during NAT and post-NAT (pre-surgery), * early ctDNA dynamics during NAT (e.g. clearance vs. persistence), * ctDNA dynamics patterns post-NAT (pre-surgery) (e.g. clearance, persistence, rebound). Specific objectives: * To evaluate the association between the ctDNA metrics and patterns detailed in the protocol. * To derive candidate early ctDNA change thresholds during NAT and estimate their predictive and prognostic value.
Prognostic and predictive value of molecular residual disease (MRD) assessed by ctDNA
To evaluate the association between post-surgery Molecular Residual Disease (MRD) and pre-surgery ctDNA status, and the correlation of post-surgery MRD with pathological residual disease at surgery, radiological response, and time-to-event efficacy outcomes.
Characterization of tumor evolution
To characterize tumor molecular evolution using longitudinal liquid biopsies (ctDNA, ctRNA, etc) collected at baseline, throughout NAT, and during follow-up.
Biomarker discovery
To identify candidate molecular biomarkers and profiles from liquid biopsies and tumor tissue that predict efficacy outcomes in early-stage disease (hypothesis-generating).
Reduction in the need for invasive procedures
To assess ctDNA as a minimal or non-invasive complement to tissue biopsies for tumor characterization and treatment monitoring across the early-stage disease.
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