neoAGORA: A Prospective Observational Study to Explore the Clinical Utility of Serial Liquid Biopsy in Patients With Early-stage Breast Cancer Receiving Neoadjuvant Therapy.
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.
• 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.
• 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.