Clinical trial NCT05452083: Postoperative Radiation of Patients With Breast Cancer in Extreme Hypofractionation.
Official title: Postoperative External Beam Whole Breast or Chest Wall Irradiation of Patients With Breast Cancer in Extreme Hypofractionation.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast cancer after complete resection and the indication for postoperative radiotherapy.

Brief summary: 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.

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

Primary outcomes:
measure: Incidence and grade of Treatment related adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)
timeFrame: 08/2022 - 07/2035
Secondary outcomes:
measure: Cosmetic results according to the Harvard-scale
timeFrame: 05/2022 - 04/2035
measure: In-breast recurrence rate
timeFrame: 05/2022 - 04/2035
measure: Quality of life during and after treatment using the patient-reported questionnaires EORTC QLQ-C30 and QLQ-BR23
timeFrame: 05/2022 - 04/2035
measure: Immune status analysis: Immunophenotyping using peripheral blood at several time points
timeFrame: 05/2022 - 04/2027
measure: Overall survival
timeFrame: 05/2022 - 04/2035
measure: Evaluation of feasibility of breath-hold radiation technique throughout the treatment time
timeFrame: 05/2022 - 04/2025
Other outcomes:
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