Postoperative Radiation of Patients With Breast Cancer in Extreme Hypofractionation.

Postoperative External Beam Whole Breast or Chest Wall Irradiation of Patients With Breast Cancer in Extreme Hypofractionation.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer after complete resection and the indication for postoperative radiotherapy.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	08/2022 - 07/2035

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	05/2022 - 04/2035
In-breast recurrence rate	Evaluation at each follow-up up to 10 years via regular examinations including mammography/ ultrasound	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	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.	05/2022 - 04/2027
Overall survival	Evaluation at each follow-up up to 10 years	05/2022 - 04/2035
Evaluation of feasibility of breath-hold radiation technique throughout the treatment time	Evaluation of patient's capability to follow breathing commandos during planning-CT scan and each application of radiotherapy	05/2022 - 04/2025

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): July 30, 2025
• Study Completion (Anticipated): July 30, 2035

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ExtremeHypofractionationBreast

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No