Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

NeoRad Breast Cancer Study

Preoperative Radiotherapy Versus Postoperative Radiotherapy After Neoadjuvant Chemotherapy ("NeoRad") in High-risk Breast Cancer: a Prospektiv, Randomized, International Multicenter Phase III Trial

NeoRad Breast Cancer Study (NCT04261244) is a Phase 3 interventional studying Breast Cancer, sponsored by Bielefeld University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Breast Cancer, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 1,826 participants makes this one of the larger Breast Cancer trials currently registered. Trials at this scale are typically global, run across many sites, and designed to generate the definitive evidence package for an FDA approval submission or a label expansion.

Who May Be Eligible (Plain English)

Who May Qualify: - Histologically proven invasive, unilateral breast cancer - Indication for radiotherapy - Indication for neoadjuvant chemotherapy (+/- antibody treatment or other targeted therapies) in accordance with national and international guidelines - Female - willing to sign a consent form for the trial signed by the patient - Hormone receptor and HER2 status: no restrictions - All grades G1-G3 - Age ≥ 18 years at the time of willing to sign a consent form - Performance status ≤ 2 - No pre-existing conditions that prohibit therapy Who Should NOT Join This Trial: - Neoadjuvant treatment solely with endocrine therapy - Bilateral breast cancer - Pregnancy or lactation - Prior radiotherapy of the thorax - Connective tissue disease, including rheumatoid arthritis and thromboangiitis obliterans - Pre-existing symptomatic chronic lung disease (fibrosis, pneumoconiosis, adult-onset allergies, such as farmer's lung, severe lung emphysema, COPD °III) - Cardiac comorbidities: symptomatic coronary heart disease, prior heart attack, heart failure NYHA ≥II or AHA ≥C, pacemaker, and/or implanted defibrillator - Malignoma except basalioma or in-situ-carcinomas in complete response - Distant metastasis - Plexopathies of the arm of the treated side - Stiffness of the shoulder of the arm of the side of the breast cancer of any origin (e.g. following a road accident) - Lymph edema ≥°II of the arm at the side of the breast cancer - Other medical conditions that prohibit the neoadjuvant radiotherapy (i.e. Expected non-compliance, etc.) - Male patients - Patients who have previously been assessed for chemotherapy response Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Histologically proven invasive, unilateral breast cancer * Indication for radiotherapy * Indication for neoadjuvant chemotherapy (+/- antibody treatment or other targeted therapies) in accordance with national and international guidelines * Female * Informed consent for the trial signed by the patient * Hormone receptor and HER2 status: no restrictions * All grades G1-G3 * Age ≥ 18 years at the time of informed consent * Performance status ≤ 2 * No pre-existing conditions that prohibit therapy Exclusion Criteria: * Neoadjuvant treatment solely with endocrine therapy * Bilateral breast cancer * Pregnancy or lactation * Prior radiotherapy of the thorax * Connective tissue disease, including rheumatoid arthritis and thromboangiitis obliterans * Pre-existing symptomatic chronic lung disease (fibrosis, pneumoconiosis, adult-onset allergies, such as farmer's lung, severe lung emphysema, COPD °III) * Cardiac comorbidities: symptomatic coronary heart disease, prior heart attack, heart failure NYHA ≥II or AHA ≥C, pacemaker, and/or implanted defibrillator * Malignoma except basalioma or in-situ-carcinomas in complete response * Distant metastasis * Plexopathies of the arm of the treated side * Stiffness of the shoulder of the arm of the side of the breast cancer of any origin (e.g. following a road accident) * Lymph edema ≥°II of the arm at the side of the breast cancer * Other medical conditions that prohibit the neoadjuvant radiotherapy (i.e. Expected non-compliance, etc.) * Male patients * Patients who have previously been assessed for chemotherapy response

Treatments Being Tested

RADIATION

preoperative radiotherapy

preoperative radiotherapy instead of postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy

RADIATION

postoperative radiotherapy

postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy

Locations (16)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

St. Marien-Krankenhaus Ahaus

Ahaus, Germany

Hochtaunus-Kliniken

Bad Homburg, Germany

Sana Klinikum Lichtenberg

Berlin, Germany

St. Agnes-Hospital

Bocholt, Germany

Städtisches Klinikum Dessau

Dessau, Germany

Universitätsfrauenklinik UK OWL, Klinikum Lippe

Detmold, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Niels-Stensen-Kliniken Franziskus-Hospital Harderberg

Georgsmarienhütte, Germany

Sana Klinikum Hameln-Pyrmont

Hamelin, Germany

Sana Klinikum Offenbach

Offenbach, Germany

medius Klinik Ostfildern-Ruit

Ostfildern, Germany

Leopoldina Krankenhaus Schweinfurt

Schweinfurt, Germany

Johanniter-Krankenhaus Stendal

Stendal, Germany

Rems-Murr-Klinikum Winnenden

Winnenden, Germany

Helios Universitätsklinikum Wuppertal

Wuppertal, Germany

Heinrich-Braun-Klinikum

Zwickau, Germany

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04261244), the sponsor (Bielefeld University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04261244 clinical trial studying?

The NEORAD trial tests whether preoperative radiotherapy results in an improved DFS and less radiation induced late effect compared to postoperative radiotherapy in higher risk breast cancer after NACT. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04261244?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04261244?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

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Source: ClinicalTrials.gov API v2 record for NCT04261244. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04261244. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.