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

Recruitingn/aAges 18 Years - anyAllSpanish Breast Cancer Research Group
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • biological samples, images, and clinical data
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Where

10 sites
Hospital Universitario Donostia
San Sebastián, Spain
Hospital del Mar
Barcelona, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Clínico Universitario San Carlos
Madrid, Spain
Hospital Clínico Universitario Virgen De la Victoria
Málaga, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Universitario de Toledo
Toledo, Spain

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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