Postoperative Radiation of Patients With Breast Cancer in Extreme Hypofractionation.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Postoperative External Beam Whole Breast or Chest Wall Irradiation of Patients With Breast Cancer in Extreme Hypofractionation.
Overview
Evaluation of treatment toxicity of extreme hypofractionation of the whole breast in five fractions of 5.2 Gy in five consecutive workdays.
Detailed description
The focus of this phase 2-trial is set on feasibility as well as early and late toxicity rates. One possible disadvantage of extreme hypofractionation could be an increased rate of fibrosis within the irradiated region. Therefore, a closer look will be taken with this prospective trial.
In addition, we are planning an accompanying translational research program since hypofractionated schedules are suggested to be more immunogenic in breast cancer.
Secondary objectives therefore are: cosmetic outcome, local tumor control, quality of life, dynamic immune status, importance of tumor infiltrating immune cells, overall survival, disease-free survival, feasibility of breath-hold radiation technique.
Primary outcome measures
- Incidence and grade of Treatment related adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0) [Time frame: 08/2022 - 07/2035]
Secondary outcome measures (6)
- Cosmetic results according to the Harvard-scale [Time frame: 05/2022 - 04/2035]
- In-breast recurrence rate [Time frame: 05/2022 - 04/2035]
- Quality of life during and after treatment using the patient-reported questionnaires EORTC QLQ-C30 and QLQ-BR23 [Time frame: 05/2022 - 04/2035]
- Immune status analysis: Immunophenotyping using peripheral blood at several time points [Time frame: 05/2022 - 04/2027]
- Overall survival [Time frame: 05/2022 - 04/2035]
- Evaluation of feasibility of breath-hold radiation technique throughout the treatment time [Time frame: 05/2022 - 04/2025]
Eligibility criteria
Inclusion criteria
- Histologically confirmed invasive breast cancer or ductal carcinoma in situ (DCIS)
- pT-category pT0-3
- complete resection (R0)
- Absence of distant metastasis (M0)
- Absence of contralateral breast cancer/ DCIS
- Karnofsky Performance Score ≥ 60%
- Age ≥ 18 years at time of study entry
- Written informed consent
Exclusion criteria
- All patients not fulfilling inclusion criteria
- Morbus Paget or pathological skin infiltration
- Earlier or synchronous breast cancer
- Pregnant or breast-feeding women
- Increased radiosensitivity or any genetic disposition for increased radiosensitivity, e.g. ataxia telangiectatica
- Judgement by the investigator that the patient is unlikely to comply with study procedures and requirements
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05452083 · ExtremeHypofractionationBreast