Clinical trial · Observational
neoAGORA: Exploring Clinical Utility of Serial Liquid Biopsy (ctDNA) in Patients With Early-Stage Breast Cancer
neoAGORA: A Prospective Observational Study to Explore the Clinical Utility of Serial Liquid Biopsy in Patients With Early-stage Breast Cancer Receiving Neoadjuvant Therapy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Breast Cancer (EBC) | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biological samples, images, and clinical data | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients diagnosed with EBC with luminal, HER2-positive and TN tumors scheduled to receive NAT.
- description
- The neoAGORA prospective cohort will include patients diagnosed with Early-stage Breast Cancer with luminal, HER2-positive and Triple Negative tumors scheduled to receive Neoadjuvant Therapy. Patients will be treated according to standard clinical practice.
- interventionNames
- Other: biological samples, images, and clinical data
Primary outcomes (1)
- measure
- Prognostic and Predictive Value of ctDNA in Patients Receiving NAT
- timeFrame
- From Study Start Date to Primary Completion Date (25 months).
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent prior to any specific study procedure. 2. Patients with willingness and ability to comply with study procedures. 3. Patients (women and men) ≥18 years of age. 4. 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: * Luminal: Hormonal Receptor(HR)-positive and HER2-negative. * HER2-positive: HER2-positive regardless of the HR status. * Triple negative: Hormonal Receptor(HR)-negative and HER2-negative. HR and HER2 status should be based on local laboratory determination following the criteria of the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) international guidelines in effect at the time of testing. 5. Patients that are scheduled to receive NAT as determined by the treating physician according to standard clinical practice. 6. Archival Formalin-Fixed, Paraffin-Embedded (FFPE) sample of the primary tumor must be available to analyze tumor-informed ctDNA assays. Exclusion Criteria: 1. Patients with stage IV BC. 2. Patients with previous anti-cancer treatment for the current BC. 3. 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. 4. Patients with a diagnosis of bilateral or multifocal breast tumors with different HR or HER2 status. 5. Patients with any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. 6. Patients who are concurrently enrolled in clinical trials. 7. Females who are pregnant or breastfeeding.
References
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