NeoRad Breast Cancer Study

NCT04261244 | Recruiting Phase 3 DMC

• 1 other identifier: NeoRad Breast Cancer Study
• Study Type: interventional
• Target: 1,826
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Breast Cancer

Keywords

neoadjuvant chemotherapy; preoperative radiotherapy; capsular contraction; immediate reconstruction

Outcome Measures

Primary Outcomes (1)

• 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.

  6 to 10 years

Secondary Outcomes (12)

• local recurrence rate [in affected breast] (LR)

  6 to 10 years

• locoregional recurrence rate (LRR)

  6 to 10 years

• disease metastases free survival (DMFS)

  6 to 10 years

• overall survival (OS)

  6 to 10 years

• disease specific survival (DSS)

  6 to 10 years

Study Arms (2)

Experimental Arm

EXPERIMENTAL

preoperative radiotherapy in breast cancer after neoadjuvant chemotherapy

Radiation: preoperative radiotherapy

Standard treatment

ACTIVE COMPARATOR

standard treatment (postoperative radiotherapy) in breast cancer after neoadjuvant chemotherapy

Radiation: postoperative radiotherapy

Interventions

preoperative radiotherapy RADIATION

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

Experimental Arm

postoperative radiotherapy RADIATION

postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy

Standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bielefeld University: lead

Study Sites (16)

St. Marien-Krankenhaus Ahaus

Ahaus, 48683, Germany

RECRUITING

Hochtaunus-Kliniken

Bad Homburg, 61352, Germany

RECRUITING

Sana Klinikum Lichtenberg

Berlin, 10365, Germany

RECRUITING

St. Agnes-Hospital

Bocholt, 46397, Germany

RECRUITING

Städtisches Klinikum Dessau

Dessau, 06847, Germany

RECRUITING

Universitätsfrauenklinik UK OWL, Klinikum Lippe

Detmold, 32756, Germany

RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

RECRUITING

Niels-Stensen-Kliniken Franziskus-Hospital Harderberg

Georgsmarienhütte, 49124, Germany

RECRUITING

Sana Klinikum Hameln-Pyrmont

Hamelin, 31785, Germany

RECRUITING

Sana Klinikum Offenbach

Offenbach, 63069, Germany

RECRUITING

medius Klinik Ostfildern-Ruit

Ostfildern, 73760, Germany

RECRUITING

Leopoldina Krankenhaus Schweinfurt

Schweinfurt, 97422, Germany

RECRUITING

Johanniter-Krankenhaus Stendal

Stendal, 39576, Germany

RECRUITING

Rems-Murr-Klinikum Winnenden

Winnenden, 71364, Germany

RECRUITING

Helios Universitätsklinikum Wuppertal

Wuppertal, 42283, Germany

RECRUITING

Heinrich-Braun-Klinikum

Zwickau, 08060, Germany

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Christiane M Prof., MD Prof.

  Bielefeld University

  STUDY CHAIR

Central Study Contacts

Christiane Matuschek, MD Prof.

CONTACT

+495215812901; christiane.matuschek@uni-bielefeld.de

Deborah Wöstenfeld, M. A.

CONTACT

+495215812972; deborah.woestenfeld@uni-bielefeld.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, multicenter

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: February 7, 2020
• Study Start: February 1, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2034
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (16)