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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Prognostic and Predictive Value of ctDNA in Patients Receiving NAT — From Study Start Date to Primary Completion Date (25 months).
  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.

Trial sites (10)

More Spanish Breast Cancer Research Group trials in Spain