Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT04261244

NeoRad Breast Cancer Study

Led by Bielefeld University · Updated on 2025-05-07

1826

Participants Needed

16

Research Sites

530 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

NeoRad Breast Cancer Study

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients
  • Histologically confirmed invasive, unilateral breast cancer
  • Indication for radiotherapy
  • Indication for neoadjuvant chemotherapy with or without antibody or targeted therapies according to guidelines
  • Age 18 years or older at time of consent
  • Performance status 0 to 2
  • No pre-existing conditions that prevent therapy
  • Hormone receptor and HER2 status with no restrictions
  • All tumor grades G1 to G3
  • Signed informed consent for the trial
Not Eligible

You will not qualify if you...

  • Neoadjuvant treatment only with endocrine therapy
  • Bilateral breast cancer
  • Pregnancy or breastfeeding
  • Prior chest radiotherapy
  • Connective tissue diseases such as rheumatoid arthritis or thromboangiitis obliterans
  • Symptomatic chronic lung diseases like fibrosis, pneumoconiosis, severe emphysema, COPD stage III
  • Significant heart conditions including symptomatic coronary artery disease, prior heart attack, heart failure NYHA class II or higher, pacemaker or implanted defibrillator
  • Other cancers except basal cell carcinoma or fully treated in-situ carcinomas
  • Distant metastases
  • Nerve damage or plexopathies in the arm on the cancer side
  • Shoulder stiffness on the cancer side from any cause
  • Arm lymphedema grade II or higher on the cancer side
  • Any medical condition that would prevent neoadjuvant radiotherapy or expected poor compliance
  • Male patients
  • Patients previously assessed for chemotherapy response

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

St. Marien-Krankenhaus Ahaus

Ahaus, Germany, 48683

Actively Recruiting

2

Hochtaunus-Kliniken

Bad Homburg, Germany, 61352

Actively Recruiting

3

Sana Klinikum Lichtenberg

Berlin, Germany, 10365

Actively Recruiting

4

St. Agnes-Hospital

Bocholt, Germany, 46397

Actively Recruiting

5

Städtisches Klinikum Dessau

Dessau, Germany, 06847

Actively Recruiting

6

Universitätsfrauenklinik UK OWL, Klinikum Lippe

Detmold, Germany, 32756

Actively Recruiting

7

Universitätsklinikum Düsseldorf

Düsseldorf, Germany, 40225

Actively Recruiting

8

Niels-Stensen-Kliniken Franziskus-Hospital Harderberg

Georgsmarienhütte, Germany, 49124

Actively Recruiting

9

Sana Klinikum Hameln-Pyrmont

Hamelin, Germany, 31785

Actively Recruiting

10

Sana Klinikum Offenbach

Offenbach, Germany, 63069

Actively Recruiting

11

medius Klinik Ostfildern-Ruit

Ostfildern, Germany, 73760

Actively Recruiting

12

Leopoldina Krankenhaus Schweinfurt

Schweinfurt, Germany, 97422

Actively Recruiting

13

Johanniter-Krankenhaus Stendal

Stendal, Germany, 39576

Actively Recruiting

14

Rems-Murr-Klinikum Winnenden

Winnenden, Germany, 71364

Actively Recruiting

15

Helios Universitätsklinikum Wuppertal

Wuppertal, Germany, 42283

Actively Recruiting

16

Heinrich-Braun-Klinikum

Zwickau, Germany, 08060

Actively Recruiting

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Research Team

C

Christiane Matuschek, MD Prof.

CONTACT

D

Deborah Wöstenfeld, M. A.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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NeoRad Breast Cancer Study | DecenTrialz