NeoRad Breast Cancer Study
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBielefeld University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Neoadjuvant treatment solely with endocrine therapy
Bilateral breast cancer
Pregnancy or lactation
Prior radiotherapy of the thorax
Trial design
Design model
Parallel
Treatments tested in this trial
preoperative radiotherapy
Radiationpreoperative radiotherapy instead of postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy
postoperative radiotherapy
Radiationpostoperative radiotherapy in breast cancer after neoadjuvant chemotherapy
Treatment groups
1,826 Participants
are divided into 2 treatment groupsGroup A: Experimental ArmExperimental treatment 1 intervention
Group B: Standard treatmentActive comparator 1 intervention
Trial outcomes
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.
Time frame
6 to 10 yearsSecondary outcomes
1
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.
Time frame
6 to 10 years2
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.
Time frame
6 to 10 years3
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.
Time frame
6 to 10 years4
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.
Time frame
6 to 10 yearsSponsors and contacts
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Source ClinicalTrials.gov