Postoperative Radiation of Patients With Breast Cancer in Extreme Hypofractionation.

University of Erlangen-Nürnberg Medical School

Status: Not yet enrolling

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05452083

ExtremeHypofractionationBreast

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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