Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation in Early Breast Cancer (HYPOSIB)

March 19, 2024 updated by: Juergen Dunst, Prof., University Hospital Schleswig-Holstein

Adjuvant Radiotherapy After Breast-conserving Surgery in Early Breast Cancer: Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation

Hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible.

Investigators initiated this multicenter two-armed phase III prospective trial to analyse the non-inferiority of hypofractionation with simultaneous integrated boost in patients with early breast cancer in comparison to standard fractionation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Control Arm:

Conventionaly fractionated radiotherapy of the breast 28 × 1.8 Gy = 50.4 Gy followed by a tumor bed boost sequentially 5 to 8 × 2.0 Gy = 10.0 Gy to 16.0 Gy, total dose 60.4 Gy to 66.4 Gy.

or Conventionaly fractionated radiotherapy of the breast 28 × 1.8 Gy = 50.4 Gy with simultaneous integrated boost to the tumor bed, total dose 28 × 0.3 Gy or 0.45 Gy= 8.4 Gy or 12,6 Gy, total dose 58,8 Gy to 63.0 Gy.

or Hypofractionated radiotherapy of the breast 16 × 2.66 Gy = 42.56 Gy followed by a tumor bed boost sequentially 5 to 8 × 2.0 Gy = 10.0 Gy to 16.0 Gy, total dose 52.56 Gy to 58.56 Gy.

Experimental Arm:

Hypofractionated radiotherapy of the breast 16 × 2.50 Gy with simultaneous integrated boost to the tumor bed, total dose within the boost volume 16 × 3.00 Gy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2324

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Amberg, Germany, 92224
        • Gesundheitszentrum St.Marien Gmbh und Klinik für Strahlentherapie
      • Aue, Germany, 08280
        • Medizinisches Versorgungszentrum Aue
      • Bad Saarow, Germany, 15526
        • Helios Klinikum Bad Saarow
      • Bad Saarow, Germany, 15526
        • Helios Kliniken Bad Saarow Klinik für Radioonkologie
      • Bayreuth, Germany, 95445
        • Strahlentherapie Klinikum Bayreuth
      • Berlin, Germany, 10243
        • Medizinisches Versorgungs Zentrum Diagnostisch Therapeutisches Zentrum am Frankfurter Tor
      • Berlin, Germany, 10559
        • Strahlentherapie in Moabit /Praxis für Strahlentherapie
      • Berlin, Germany, 12157
        • Praxis für Radioonkologie und Strahlentherapie Berlin Südwest
      • Berlin, Germany, 12200
        • Ambulantes Gesundheitszentrum der Dr. med Maria Sternemann Charte -Universitätsmedizin Berlin
      • Berlin, Germany, 12351
        • Vivantes-Klinikum Berlin-Neukölln
      • Berlin, Germany, 13125
        • HELIOS Klinikum Berlin-Buch, Strahlentherapeutische Klinik
      • Berlin, Germany, 13353
        • Charite berlin (Virchow) Klinik für Strahlentherapie
      • Berlin, Germany, 14050
        • DRK Kliniken Berlin: Zentrum für Strahlentherapie MVZ pro patiente Westend
      • Berlin, Germany, 14165
        • MZV am HELIOS Klinikum Emil von Behring
      • Berlin ( Mitte), Germany, 10249
        • MVZ Chariete Vivantes Gmbh Strahlentherapie
      • Bocholt, Germany, 46399
        • Gemeinschaftspraxis und Belegabteilung für Strahlentherapie
      • Bremen, Germany, 28205
        • Ambulanz Bremen GMBH MVZ RadioOnkologie
      • Bremen, Germany, 28239
        • Zentrum für Strahlentherapie undRadioonkologie
      • Buchholz, Germany, 21244
        • Krankenhaus Buchholz Abteilung für Strahlentherapie
      • Coesfeld, Germany, 48653
        • Strahlentherapie Coesfeld
      • Deggendorf, Germany, 94469
        • Radiologie Strahlentherapie-Zweigpraxis vom MVZ Passau
      • Dresden, Germany, 01067
        • Praxis für Strahlentherapie Krankenhaus Dresden-Friedrichsstadt
      • Duisburg, Germany, 470530
        • Malteser MVZ Duisburg-Süd
      • Dusseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf Klinik und Poliklinik für Strahlentherapie und Radioologische Onkologie
      • Elmshorn, Germany, 25337
        • Gemeinschaftspraxis für Strahlentherapie und Radioonkologie
      • Esslingen, Germany, 73730
        • MVZ Strahlentherapie Klinikum Esslingen GmbH
      • Frankfurt/M, Germany, 60590
        • Klinik für Strahlentherapie und Onkologie
      • Frankfurt/Oder, Germany, 15236
        • Klinikum Frankfurt (Oder)Klinikum für Strahlentherapie Radioonkologie
      • Fürth, Germany, 90766
        • Strahlentherapie am Klinikum Fürth
      • Gelsenkirchen, Germany, 45899
        • Strahlentherapiezentrum- Escher-Lippe(STZELL) und die Katholischen Kliniken-Emscher
      • Gießen, Germany, 35392
        • Justus-Liebig Universität Gießen Strahlentherapie
      • Goch, Germany, 47574
        • Praxis für Strahlentherapie Goch
      • Göppingen, Germany, 73035
        • Brustzentrum ALB FILS Kliniken GMBH
      • Hamburg, Germany, 20246
        • Ambulanzzentrum des UKE GmbH Bereich der Strahlentherapie
      • Hamburg, Germany, 22307
        • Radiologische Ambulanz Fachärzte für Radiologie,Nuklearmedizin und Strahlentherapie
      • Hamburg, Germany, 22419
        • Strahlenzentrum Hamburg
      • Hamburg Harburg, Germany, 21075
        • Dr.med Jürgen Heide Facharzt für Strahlentherapie
      • Hameln, Germany, 31785
        • GSR Hameln
      • Hannover, Germany, 30161
        • Gemeinschaftspraxis für Strahlentherapie und Radioonkologie / Hannover/Hildesheim/Hameln
      • Hannover, Germany, 30449
        • GSR Hannover Siloa
      • Hildesheim, Germany, 31134
        • Gemeinschaftspraxis für Strahlentherapie und Radioonkologie(GSR)
      • Hildesheim, Germany, 31135
        • Gemeinschaftspraxis für Strahlentherapie Hildesheim/Goslar
      • Hildesheim, Germany, 31135
        • Gemeinschaftspraxis für Strahlentherapie/Hildesheim/Goslar
      • Hof, Germany, 95032
        • Strahlentherapie Hof
      • Karlsruhe, Germany, 76135
        • MVZ St. Vincent-Kliniken gAG
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein
      • Kiel, Germany, 24105
        • Praxis für Strahlentherapie am Universitätsklinikum Schleswig-Holstein
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leibzig
      • Lemgo, Germany, 32657
        • Klinikum für Strahlentherapie - Klinikum Lippe
      • Ludwigsburg, Germany, 71640
        • Klinikum Ludwigsburg Klinik für Radioonkologie
      • Lüneburg, Germany, 21339
        • Klinikum Lüneburg, Klinik für Strahlentherapie und Radioonkologie
      • Lünen, Germany, 44534
        • MVZ Prof.Dr.Uhlenbrock und Partner Strahlentherapie Lünen
      • Mainz, Germany, 55131
        • Klinik und Poliklinik für Radioonkologie und Strahlentherapie Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • Mannheim, Germany, 68309
        • Praxis für Strahlentherapie Mannheim
      • Marburg, Germany, 35033
        • Universitätsklinikum Marburg Strahlentherapie und Radioonkologie
      • Meiningen, Germany, 98617
        • Brustzentrum Helios Klinikum
      • Monchengladbach, Germany, 41063
        • Kliniken Maria Hilf Gmbh Klinik für Strahlentherapie
      • Muenchen, Germany, 81675
        • Klinikum Rechts der Isar
      • Münster, Germany, 48149
        • Klinik für Strahlentherapie- Radioonkologie
      • Münster, Germany, 48153
        • Praxis für Strahlentherapie und Radioonkologie am Clemenshospital
      • Neckarsulm, Germany, 74172
        • Strahlentherapie Neckarsulm
      • Neubrandenburg, Germany, 17022
        • Dietrich Bonhoeffer Klinikum Neubrandenburg
      • Neunkirchen, Germany, 66538
        • Praxis für Strahlentherapie Im Städtischen Klinikum Neunkirchen
      • Oldenburg, Germany, 26121
        • Klinik für Strahlentherapie und Radioonkologie Pius-Hospital Oldenburg
      • Osnabrück, Germany, 49076
        • Zentrum für Strahlentherapie Rheine-Osnabrück
      • Passau, Germany, 94032
        • MVZ Radio-LOG Schie in Altötting
      • Pinneberg, Germany, 25421
        • Visiorad - Bereich Strahlentherapie
      • Potsdam, Germany, 14467
        • Klinikum für Radioonkologie Klinikum Ernst von Bergmann
      • Regensburg, Germany, 93049
        • Krankenhaus Barmherzige Brüder Regensburg Medizinisches Versorgungszentrum
      • Rheine, Germany, 48431
        • Überörtliche Gemeinschaftspraxis/Fachärzte für Strahlentherapie
      • Ruit, Germany, 73760
        • Kreiskliniken Esslingen Paracelsus Krankenhaus Ruit
      • Saarbrucken, Germany, 66113
        • CaritasKlinikum Saarbrücken
      • Saarlouis, Germany, 66740
        • XCare Praxis für Strahlentherapie
      • Schweinfurt, Germany, 97422
        • MVZ Leopoldina Strahlentherapie
      • Schweinfurt, Germany, 97422
        • MVZ Leopoldina
      • Schwerin, Germany, 19055
        • Helios Kliniken Schwerin GmbH
      • Stendal, Germany, 39576
        • Johanniter Zentren für medizinische Versorgung in der Altmark GMBH
      • Stendal, Germany, 39576
        • Johanniter Zentrum für Medizinische Versorgung
      • Straubing, Germany, 94315
        • MVZ Klinikum Straubing GMBH Strahlentherapie
      • Stuttgart, Germany, 70176
        • MVZ-Uniklinik Tübingen gGmbH
      • Trier, Germany, 54293
        • Praxis für Strahlentherapie Trier Ehrang
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen
      • Ulm, Germany, 89081
        • Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Ulm
      • Villingen-Schwenningen, Germany, 78052
        • Klinik für Strahlentherapie und Radioonkologie Schwarzwald-Baar -Klinikum
      • Weilheim, Germany, 82362
        • Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim
      • Wolfsberg, Germany, 38440
        • Medizinisches Versorgungszentrum Wolfsburg GmbH
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg Klinik und Poliklinik für Strahlentherapie
      • Zwickau, Germany, 08060
        • Heinrich-Braun-Klinikum Zwickau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins independently of further risk factors (positive or high-risk negative lymph node status, estrogen- or progesterone receptor status, Her-2/neu status uPA/PAI-1 criteria) and postoperative systemic therapy (chemotherapy, endocrine, antibody or bisphosphonate therapy were permitted when indicated)
  • Indication to adjuvant radiotherapy including boost radiotherapy
  • Clearly identified primary tumor region preferably by radiopaque clips
  • Primary wound healing after breast conserving therapy without signs of infection
  • Age ≥ 18 years
  • ECOG ≤ 2 Performance Status
  • Written informed consent
  • Compliance regarding treatment appointments and toxicity
  • Linguistic and cognitive ability to understand the questionnaires

Exclusion Criteria:

  • Patients operated by mastectomy
  • No indication for boost radiation (e.g. status after IORT)
  • double sided breast cancer
  • Resection margins positive for disease or insufficient identification of the boost volume
  • Indication for radiotherapy of the regional lymph nodes
  • History of prior breast or thoracic radiotherapy
  • Extended postoperative seroma at the beginning of radiotherapy
  • Previously administered radiotherapy not allowing the required dose
  • Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
  • treatment history of other cancer or participation in another clinical trial testing radiotherapy or drugs within 4 weeks of the start of treatment.
  • Patients with serious, uncontrolled, physical or cerebrovascular disorders(e.g. myocardial infarction within the last 12 months) or neurologiy or psychiatric disorders thought to adversly affect treatment compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard radiation

Conventionally fractionated radiotherapy of the breast followed by a tumor bed boost sequentially or

Conventionally fractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed or

Hypofractionated radiotherapy of the breast followed by a tumor bed boost sequentially
Radiation: Standard Radiation

Conventionally fractionated radiotherapy of the breast followed by a tumor bed boost sequentially or

Conventionally fractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed or

Hypofractionated radiotherapy of the breast followed by a tumor bed boost sequentially
Experimental: Hypofractionation with SIB
Hypofractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed
Radiation: Hypofractionation with SIB
Hypofractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 3 to 6 years
any local or regional recurrence or distant metastasis or death
3 to 6 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to occurence of local recurrence
Time Frame: 3 to 6 years
ipsilateral in-breast recurrence
3 to 6 years
Overall survival
Time Frame: 3 to 6 years
death
3 to 6 years
Safety and side effects (Number of Patients with Adverse Events)
Time Frame: 3 to 6 years
Number of Patients with Adverse Events
3 to 6 years
Acute and chronic toxicity (NCI-CTCAE)
Time Frame: 1 day, 7 days, end of radiation (last day of radiation and closing visite), 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months, 66 months, 72 months
All dimensions of NCI-CTCAE
1 day, 7 days, end of radiation (last day of radiation and closing visite), 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months, 66 months, 72 months
Cosmetic results (NCI-CTCAE)
Time Frame: 1 day, end of radiation (last day of radiation and closing visite), 3 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months
NCI-CTCAE
1 day, end of radiation (last day of radiation and closing visite), 3 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Schleswig-Holstein

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Luebeck

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jürgen Dunst, MD, University Medical Center Schleswig-Holstein (UKSH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 16, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 8, 2019

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ARO-2013-05, ZKS-121-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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