Breast CancerPhase 3NeoRadNCT04261244
NeoRad Breast Cancer Study
A Phase 3 study testing preoperative radiotherapy and postoperative radiotherapy in people with Breast Cancer, run by Bielefeld University at 16 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- preoperative radiotherapy and postoperative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,826 participants
- Where
- 16 sitesGermany
- Study dates
- 1 Feb 2024to 31 Mar 2034
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- All grades G1-G3
- Age ≥ 18 years at the time of informed consent
- Performance status ≤ 2
- No pre-existing conditions that prohibit therapy
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
Germany16 sites, 16 recruiting
- Recruiting
St. Marien-Krankenhaus Ahaus
Ahaus, 48683
Alexandra Nienhaus, +4925619923208, gynaekologie.ahaus@kwml.de
- Recruiting
Hochtaunus-Kliniken
Bad Homburg, 61352
Uta-Ruth Schindelin, Dr. med., +496172142580, Uta.Schindelin@hochtaunus-kliniken.de
- Recruiting
Sana Klinikum Lichtenberg
Berlin, 10365
Maria Hufnagel, Dr. med., +493055182450, maria.hufnagel@sana.de
- Recruiting
St. Agnes-Hospital
Bocholt, 46397
Judith Gissing, Dr. med., +492871202740, brustzentrum-bocholt@kwml.de
- Recruiting
Städtisches Klinikum Dessau
Dessau, 06847
Hermann Voß, Dr. med., +493405014310
- Recruiting
Universitätsfrauenklinik UK OWL, Klinikum Lippe
Detmold, 32756
Beyhan Ataseven, Prof. Dr. med., +495231723141, frauenklinik@klinikum-lippe.de
- Recruiting
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Tanja Fehm, MD Prof., +492118117501, direktion.frauenklinik@med.uni-duesseldorf.de
- Recruiting
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg
Georgsmarienhütte, 49124
Thorsten Heilmann, Dr. med., +495415023120, senologie-fhh@nsk.de
- Recruiting
Sana Klinikum Hameln-Pyrmont
Hamelin, 31785
Janine König, +495151971241, janine.koenig@sana.de
- Recruiting
Sana Klinikum Offenbach
Offenbach, 63069
Peter Niehoff, Prof. Dr. med., +496984053335, strahlenklinik-sof@sana.de
- Recruiting
medius Klinik Ostfildern-Ruit
Ostfildern, 73760
Matthias Geiger, Dr. med., +49711448811650, n.cerito@medius-kliniken.de
- Recruiting
Leopoldina Krankenhaus Schweinfurt
Schweinfurt, 97422
Elke Wiegand, Dr. med., +4997217202132, frauenklinik@leopoldina.de
- Recruiting
Johanniter-Krankenhaus Stendal
Stendal, 39576
Sylvia Ruth, Dr. med., +493931668020, manuela.wenzel@sdl.johanniter-krankenhaus.de
- Recruiting
Rems-Murr-Klinikum Winnenden
Winnenden, 71364
Hans-Joachim Strittmatter, Prof. Dr. med., +49719559139220, gynaekologie.winnenden@rems-murr-kliniken.de
- Recruiting
Helios Universitätsklinikum Wuppertal
Wuppertal, 42283
Marc D Piroth, Prof. Dr. med., +492028962821, kirsten.clement@helios-gesundheit.de
- Recruiting
Heinrich-Braun-Klinikum
Zwickau, 08060
Alexander D Boicev, Dr. med., +40375512802, stra@hbk-zwickau.de
About this study
Official title: Preoperative Radiotherapy Versus Postoperative Radiotherapy After Neoadjuvant Chemotherapy ("NeoRad") in High-risk Breast Cancer: a Prospektiv, Randomized, International Multicenter Phase III Trial
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.
Read the detailed description
The standard of care for high-risk breast cancer consists of neoadjuvant chemotherapy and surgery followed by postoperative whole breast/chest wall irradiation+/- an additional boost (= irradiation restricted to the tumour bed in the case of breast-conserving therapy). In case of lymph node involvement in most patients require additional radiation of the regional lymph nodes. Adjuvant radiotherapy significantly reduces ipsilateral breast cancer recurrences, breast cancer specific mortality, and overall mortality. The optimal time of radiotherapy in patients, who are candidates for neoadjuvant chemotherapy (NACT) has never been addressed in a randomised controlled trial.
The Study Chairman of the NEORAD trial is Prof. Dr. med. Christiane Matuschek. The deputies of the Study Chairman are Prof. Dr. med. Wilfried Budach and Prof. Dr. med. Tanja Fehm.
- Conditions
- Breast Cancer
- Being tested
- preoperative radiotherapy, postoperative radiotherapy
- Keywords
- neoadjuvant chemotherapy, preoperative radiotherapy, capsular contraction, immediate reconstruction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative radiotherapyRadiation
preoperative radiotherapy instead of postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy
postoperative radiotherapyRadiation
postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | preoperative radiotherapy in breast cancer after neoadjuvant chemotherapy Receives: Radiation: preoperative radiotherapy |
| Standard treatment | Active comparator | standard treatment (postoperative radiotherapy) in breast cancer after neoadjuvant chemotherapy Receives: Radiation: postoperative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival (DFS):
Time interval in which the patient does not show any signs or symptoms of the treated cancer (local or regional recurrence, distant metastases, or death of any cause) beginning after randomisation to a study arm.
This is a way to measure how well the new treatment is working.
Measured: 6 to 10 years
Secondary outcomes (12)
local recurrence rate [in affected breast] (LR)
Rate of cancer that has recurred at the same location as the primary cancer. This is a way to measure how well the new treatment is working.
Measured: 6 to 10 years
locoregional recurrence rate (LRR)
Rate of new cancer at any locations (regional lymph nodes, chest wall/mastectomy site) on side which was previously affected by the primary cancer.
This is a way to measure how well the new treatment is working.
Measured: 6 to 10 years
disease metastases free survival (DMFS)
Time interval beginning after randomisation in which the patient survives and the cancer has not metastasized.
This is a way to measure how well the new treatment is working.
Measured: 6 to 10 years
overall survival (OS)
Length of time beginning after randomisation in the study that the patient survives.
This is a way to measure how well the new treatment is working.
Measured: 6 to 10 years
disease specific survival (DSS)
Length of time from the beginning of the study after randomisation in a study arm that the patient survives the specific cancer.
This is a way to measure how well the new treatment is working.
Measured: 6 to 10 years
Assesment of cosmetic results by the physicians and the patient using a 5 point Scoring System*
A grading scale is provided for cosmetic results (5 Point Scoring System):
E0 Excellent aesthetic result: At first sight no visible therapy sequellae. Both breasts have a similar appearance E1 Good: minimal changes in pigmentation, a visible scar, localized teleangieectasia.
E2 Moderate: marked sequellae with a clear deformation of the breast contour, nipple displacement, or marked skin changes, but yet "acceptable".
E3 Bad: severe retraction or fibrosis, severe teleangiectasia. E4 Complications: skin necrosis
Measured: 6 to 10 years
Assesment of cosmetic results by the physicians using breast retraction assessment-Score (BRA Score)*
*The BRA Score measures breast symmetry of the treated breast in comparison to the untreated breast. The average in the general population is 1.2 cm. A higher BRA score is worse. A BRA score of 0 cm is optimal.
Measured: 6 to 10 years
Measurement of the quality of life (QOL): functional scale
QoL will be assessed by EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 questionnaires for overall QoL and EORTC QLQ-BR23 for breast-specific QoL. The QLQ-C30 consists of 30 questions categorized in functional and symptom-specific scales and provides a global score through two general questions concerning health and quality of life. QLQ-BR23 is a standard instrument for measuring QoL in patients with breast cancer. The questionnaire has 23 items with four possible answers each (not at all, a little, quite a bit, very much). Results are reported using functional scales (e.g. body image, sexual functioning) and symptom-related items (e.g. systemic therapy side effects, breast symptoms). It is also common practice to classify the summary scores into four distinct categories with functional scales (0-25 bad; 26-50 moderate; 51-75 good; 76-100 excellent) and symptom-related scales.
Measured: 6 to 10 years
Measurement of the quality of life (QOL): symptom-related scale
QoL will be assessed by EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 questionnaires for overall QoL and EORTC QLQ-BR23 for breast-specific QoL. The QLQ-C30 consists of 30 questions categorized in functional and symptom-specific scales and provides a global score through two general questions concerning health and quality of life. QLQ-BR23 is a standard instrument for measuring QoL in patients with breast cancer. The questionnaire has 23 items with four possible answers each (not at all, a little, quite a bit, very much). Results are reported using functional scales (e.g. body image, sexual functioning) and symptom-related items (e.g. systemic therapy side effects, breast symptoms). It is also common practice to classify the summary scores into four distinct categories with functional scales and symptom-related scales: (0-25 excellent; 26-50 good; 51-75 moderate, 76-100 bad)
Measured: 6 to 10 years
Assessment of arm lymphedema rates by the physicians using common toxicity criteria for adverse events CTCAE, version 5.0
Lymphedema: 'A disorder characterized by excessive fluid collection in tissues that causes swelling.'
A grading scale is provided for arm lymphoedema rates higher than Grade 1 of the irradiated side (0= "not present", 1= "Trace thickening or faint discoloration", 2= "Marked discoloration; leathery skin texture; papillary formation; limiting instrumental ADL*", 3= "Severe symptoms; limiting self care ADL") using common toxicity criteria for adverse events CTCAE, version 5.0
*ADL = activities of daily living
Measured: 6 to 10 years
Assessment of plexopathia higher than Grade 1 of brachial plexus on irradiated side by the physicians using common toxicity criteria for adverse events CTCAE, version 5.0
Brachial plexopathia:'"A disorder characterized by regional paresthesia of the brachial plexus, marked discomfort and muscle weakness, and limited movement in the arm or hand.'
A grading scale is provided for plexopathia of brachial plexus on the irradiated side higher than Grade 1 (0= "not present", 1= "Aysmptomatic; clinical or diagnostic observations only; intervention not indicated", 2= "Moderate symptoms; limiting instrumental ADL*", 3= "Severe symptoms, limiting self care ADL") using common toxicity criteria for adverse events CTCAE, version 5.0
*ADL = activities of daily living
Measured: 6 to 10 years
Assessment of treatment-related toxicity measured by the physicians using standardized common toxicity criteria for adverse events CTCAE, version 5.0.
A grading scale is provided for each side effect (0= not present, 1=asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, 3=moderate; minimal, local or noninvasive intervention indicated; -4=severe or medically significant but not immediately life-threatening)
Measured: 6 to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start1 Feb 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, multicenter
- Masking
- None (open label)
- Enrolment
- 1,826 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bielefeld University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christiane M Prof., MD Prof., Study chair, Bielefeld University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261244
- Sponsor's protocol ID
- NeoRad Breast Cancer Study
- Acronym
- NeoRad
- Status last verified
- May 2025
- First submitted
- 30 Sep 2019
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Radiotherapy Versus Postoperative Radiotherapy After Neoadjuvant Chemotherapy ("NeoRad") in High-risk Breast Cancer: a Prospektiv, Randomized, International Multicenter Phase III Trial
- ClinicalTrials.gov ID
- NCT04261244
- Acronym / sponsor ID
- NeoRad / NeoRad Breast Cancer Study
- Conditions
- Breast Cancer
- Keywords
- neoadjuvant chemotherapy, preoperative radiotherapy, capsular contraction, immediate reconstruction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,826 participants (estimated)
- Lead sponsor
- Bielefeld UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2034 (estimated)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The standard of care for high-risk breast cancer consists of neoadjuvant chemotherapy and surgery followed by postoperative whole breast/chest wall irradiation+/- an additional boost (= irradiation restricted to the tumour bed in the case of breast-conserving therapy). In case of lymph node involvement in most patients require additional radiation of the regional lymph nodes. Adjuvant radiotherapy significantly reduces ipsilateral breast cancer recurrences, breast cancer specific mortality, and overall mortality. The optimal time of radiotherapy in patients, who are candidates for neoadjuvant chemotherapy (NACT) has never been addressed in a randomised controlled trial.
The Study Chairman of the NEORAD trial is Prof. Dr. med. Christiane Matuschek. The deputies of the Study Chairman are Prof. Dr. med. Wilfried Budach and Prof. Dr. med. Tanja Fehm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, multicenter
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Radiation: preoperative radiotherapypreoperative radiotherapy in breast cancer after neoadjuvant chemotherapy |
| Standard treatment | Active comparator | Radiation: postoperative radiotherapystandard treatment (postoperative radiotherapy) in breast cancer after neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoperative radiotherapypreoperative radiotherapy instead of postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy | Radiation | Experimental Arm |
| postoperative radiotherapypostoperative radiotherapy in breast cancer after neoadjuvant chemotherapy | Radiation | Standard treatment |
Primary outcome
disease free survival (DFS):
Time frame: 6 to 10 years
Time interval in which the patient does not show any signs or symptoms of the treated cancer (local or regional recurrence, distant metastases, or death of any cause) beginning after randomisation to a study arm. This is a way to measure how well the new treatment is working.
12 secondary outcomes
local recurrence rate [in affected breast] (LR)
Time frame: 6 to 10 years
locoregional recurrence rate (LRR)
Time frame: 6 to 10 years
disease metastases free survival (DMFS)
Time frame: 6 to 10 years
overall survival (OS)
Time frame: 6 to 10 years
disease specific survival (DSS)
Time frame: 6 to 10 years
Assesment of cosmetic results by the physicians and the patient using a 5 point Scoring System*
Time frame: 6 to 10 years
Assesment of cosmetic results by the physicians using breast retraction assessment-Score (BRA Score)*
Time frame: 6 to 10 years
Measurement of the quality of life (QOL): functional scale
Time frame: 6 to 10 years
Measurement of the quality of life (QOL): symptom-related scale
Time frame: 6 to 10 years
Assessment of arm lymphedema rates by the physicians using common toxicity criteria for adverse events CTCAE, version 5.0
Time frame: 6 to 10 years
Assessment of plexopathia higher than Grade 1 of brachial plexus on irradiated side by the physicians using common toxicity criteria for adverse events CTCAE, version 5.0
Time frame: 6 to 10 years
Assessment of treatment-related toxicity measured by the physicians using standardized common toxicity criteria for adverse events CTCAE, version 5.0.
Time frame: 6 to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christiane M Prof., MD Prof. study chair
Bielefeld University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing preoperative radiotherapy and postoperative radiotherapy in people with Breast Cancer, run by Bielefeld University at 16 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christiane Matuschek, MD Prof. (+495215812901, christiane.matuschek@uni-bielefeld.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival (DFS): (time frame: 6 to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.