Postoperative Radiation of Patients With Breast Cancer in Extreme Hypofractionation.

N/ANot Yet RecruitingNCT05452083

University of Erlangen-Nürnberg Medical School100 enrolled

Overview

Evaluation of treatment toxicity of extreme hypofractionation of the whole breast in five fractions of 5.2 Gy in five consecutive workdays.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence and grade of Treatment related adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)

Evaluation during treatment and at each follow-up visit up to 10 years

Time frame: 08/2022 - 07/2035

Secondary Outcomes

Cosmetic results according to the Harvard-scale

Clinical evaluation of the irradiated breast at each follow-up up to 10 years according to the Harvard-scale (patient's and physician's view)

Time frame: 05/2022 - 04/2035

In-breast recurrence rate

Evaluation at each follow-up up to 10 years via regular examinations including mammography/ ultrasound

Time frame: 05/2022 - 04/2035

Quality of life during and after treatment using the patient-reported questionnaires EORTC QLQ-C30 and QLQ-BR23

Evaluation of patient's quality of life from inclusion to each follow-up up to 10 years via standardized questionnaires: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30 and the breast-orientated QLQ-BR23

Time frame: 05/2022 - 04/2035

Immune status analysis: Immunophenotyping using peripheral blood at several time points

Withdrawals of whole blood (plasma and serum) before the first irradiation until one year after the treatment. Immunophenotyping by a modular multicolor flow cytometry-based method. Furthermore, whole exome sequencing/RNASeq on already obtained tissue from the breast surgery.

Time frame: 05/2022 - 04/2027

Overall survival

Evaluation at each follow-up up to 10 years

Time frame: 05/2022 - 04/2035

Data from ClinicalTrials.gov

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