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NCT Number: NCT05452083

Postoperative Radiation 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

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

Secondary outcomes

  1. Cosmetic results according to the Harvard-scale

    Time frame: 05/2022 - 04/2035

    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)

  2. In-breast recurrence rate

    Time frame: 05/2022 - 04/2035

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

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

    Time frame: 05/2022 - 04/2035

    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

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

    Time frame: 05/2022 - 04/2027

    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.

  5. Overall survival

    Time frame: 05/2022 - 04/2035

    Evaluation at each follow-up up to 10 years

  6. Evaluation of feasibility of breath-hold radiation technique throughout the treatment time

    Time frame: 05/2022 - 04/2025

    Evaluation of patient's capability to follow breathing commandos during planning-CT scan and each application of radiotherapy

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2035
First posted
Jul 11, 2022
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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