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

NCT07718841 | Not Yet Recruiting

• 1 other identifier: GEICAM/2023-14
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Early Breast Cancer (EBC)

Keywords

liquid biopsy; early-stage breast cancer; ctDNA; digital pathology; neoadjuvant therapy (NAT)

Outcome Measures

Primary Outcomes (1)

• 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.

  From Study Start Date to Primary Completion Date (25 months).

Secondary Outcomes (8)

• Prognostic and predictive value of molecular residual disease (MRD) assessed by ctDNA

  From Study Start Date to Study Completion Date (84 months).

• Characterization of tumor evolution

  From Study Start Date to Study Completion Date (84 months).

• Biomarker discovery

  From Study Start Date to Study Completion Date (84 months).

• Reduction in the need for invasive procedures

  From Study Start Date to Study Completion Date (84months).

• Imaging predictions of tumor response and disease relapse

  From Study Start Date to Study Completion Date (84 months). This will only be conducted if funding is obtained.

Study Arms (1)

Patients diagnosed with EBC with luminal, HER2-positive and TN tumors scheduled to receive NAT.

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.

Other: biological samples, images, and clinical data

Interventions

biological samples, images, and clinical data OTHER

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.

Patients diagnosed with EBC with luminal, HER2-positive and TN tumors scheduled to receive NAT.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population for inclusion in this study is BC patients scheduled to receive neoadjuvant treatment.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Patients who are concurrently enrolled in clinical trials.
• Females who are pregnant or breastfeeding.

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead

Study Sites (10)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital Universitario Donostia

San Sebastián, Guipúzcoa, 20014, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, 28009, Spain

Location

Hospital Clínico Universitario San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Clínico Universitario Virgen De la Victoria

Málaga, Málaga, 29010, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Sevilla, 41009, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Sevilla, 41013, Spain

Location

Hospital Universitario de Toledo

Toledo, Toledo, 45007, Spain

Location

Instituto Valenciano de Oncologia

Valencia, Valencia, 46009, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain

Location

Related Links

• GEICAM is a Spanish Breast Cancer Research Group

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for ctDNA and other biomarker analyses. Blood samples peripheral blood mononuclear cells and germline DNA (gDNA) analysis. Formalin-Fixed Paraffin-Embedded (FFPE) tumor samples and digital pathology imaging for biomarker and genomic/epigenomic analysis.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Study Director

  Hospital Donostia

  STUDY DIRECTOR

• Study Director

  Instituto Valenciano de Oncología

  STUDY DIRECTOR

• Study Director

  Hospital Clínico Universitario San Carlos

  STUDY DIRECTOR

• Study Director

  Hospital General Universitario Gregorio Marañón

  STUDY DIRECTOR

• Study Director

  Hospital Clínico Universitario Virgen de la Victoria

  STUDY DIRECTOR

Central Study Contacts

Study Project Manager

CONTACT

+34916592870; inicio_ensayos@geicam.org

Start-Up Unit Manager

CONTACT

+34916592870; inicio_ensayos@geicam.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 22, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): August 1, 2033
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)