BridgeMD
New treatment option for Breast Cancer
Official title NeoRad Breast Cancer Study
ClinicalTrials.gov ID: NCT04261244
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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
You likely can't join 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...
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ahaus, Germany
- Bad Homburg, Germany
- Berlin, Germany
- Bocholt, Germany
- Dessau, Germany
- Detmold, Germany
- Düsseldorf, Germany
- Georgsmarienhütte, Germany
- Hamelin, Germany
- Offenbach, Germany
- Ostfildern, Germany
- Schweinfurt, Germany
- Stendal, Germany
- Winnenden, Germany
- Wuppertal, Germany
- Zwickau, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ahaus, Germany; Bad Homburg, Germany; Berlin, Germany; Bocholt, Germany; Dessau, Germany; Detmold, Germany and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.