Breast CancerNCT05452083
Postoperative Radiation of Patients With Breast Cancer in Extreme Hypofractionation.
An observational study of Breast Cancer, run by University of Erlangen-Nürnberg Medical School.
Trial summary
Evaluation of treatment toxicity of extreme hypofractionation of the whole breast in five fractions of 5.2 Gy in five consecutive workdays. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 30 Jul 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer after complete resection and the indication for postoperative radiotherapy.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 08/2022 - 07/2035
Secondary outcomes (6)
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)
Measured: 05/2022 - 04/2035
In-breast recurrence rate
Evaluation at each follow-up up to 10 years via regular examinations including mammography/ ultrasound
Measured: 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
Measured: 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.
Measured: 05/2022 - 04/2027
Overall survival
Evaluation at each follow-up up to 10 years
Measured: 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
Measured: 05/2022 - 04/2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Jul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Schweizer, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452083
- Sponsor's protocol ID
- ExtremeHypofractionationBreast
- Status last verified
- Jul 2022
- First submitted
- 22 Apr 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative External Beam Whole Breast or Chest Wall Irradiation of Patients With Breast Cancer in Extreme Hypofractionation.
- ClinicalTrials.gov ID
- NCT05452083
- Acronym / sponsor ID
- ExtremeHypofractionationBreast
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2035 (estimated)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer after complete resection and the indication for postoperative radiotherapy.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Cosmetic results according to the Harvard-scale
Time frame: 05/2022 - 04/2035
In-breast recurrence rate
Time frame: 05/2022 - 04/2035
Quality of life during and after treatment using the patient-reported questionnaires EORTC QLQ-C30 and QLQ-BR23
Time frame: 05/2022 - 04/2035
Immune status analysis: Immunophenotyping using peripheral blood at several time points
Time frame: 05/2022 - 04/2027
Overall survival
Time frame: 05/2022 - 04/2035
Evaluation of feasibility of breath-hold radiation technique throughout the treatment time
Time frame: 05/2022 - 04/2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Erlangen-Nürnberg Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.