NeoRad Breast Cancer Study

Bielefeld University

Status and phase: Enrolling; Phase 3

Conditions: Breast Cancer

Treatments: Radiation: postoperative radiotherapy; Radiation: preoperative radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04261244

NeoRad Breast Cancer Study

Details and patient eligibility

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.

Full 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.

Enrollment: 1,826 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,826 participants in 2 patient groups

Experimental Arm

Experimental group

Description:

preoperative radiotherapy in breast cancer after neoadjuvant chemotherapy

Treatment:

Radiation: preoperative radiotherapy

Standard treatment

Active Comparator group

Description:

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

Treatment:

Radiation: postoperative radiotherapy