xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05975190</url>
    </required_header>
    <id_info>
      <org_study_id>2020-277_1-S-NP</org_study_id>
      <nct_id>NCT05975190</nct_id>
    </id_info>
    <brief_title>Respiratory Training and Relaxation Techniques to Improve Adjuvant Radiation Therapy in DIBH in Breast Cancer</brief_title>
    <acronym>B-REST</acronym>
    <official_title>Respiratory Training and Relaxation Techniques to Improve Adjuvant Radiation Therapy in DIBH in Breast Cancer Patients - B-REST-Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Technical University of Munich</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>German Cancer Aid</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Technical University of Munich</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this prospective clinical trial is to improve patient compliance and performance&#xD;
        of deep inspiration breath hold (DIBH) to further reduce the cardiac dose from left breast&#xD;
        radiation, and to improve cooperation and patient satisfaction through an active and formal&#xD;
        pre-treatment respiratory training program combined with relaxation training (R&amp;R) in breast&#xD;
        cancer patients undergoing adjuvant radiotherapy for left sided breast cancer.&#xD;
  &#xD;
        The main questions the study aims to answer are:&#xD;
  &#xD;
          -  Does the use of communication training and the use of relaxation techniques (R&amp;R) reduce&#xD;
             the Maximum dose to the heart (Dmax) and improve further heart dose parameters in deep&#xD;
             inspiration during adjuvant radiotherapy for breast cancer?&#xD;
  &#xD;
          -  Does R&amp;R improve longitudinal anxiety and quality of life under patients undergoing DIBH&#xD;
             adjuvant radiotherapy for left sided breast cancer?&#xD;
  &#xD;
        Participants will be randomly assigned to either an experimental arm, which will receive the&#xD;
        R&amp;R, versus a standard arm that will not receive the R&amp;R.&#xD;
  &#xD;
          -  training program in the experimental arm includes breath hold training, music, and&#xD;
             nature sounds that patients can listen to on an MP3 player&#xD;
  &#xD;
          -  both groups complete standardized questionnaires about their well-being and satisfaction&#xD;
             at prospective time points before, during the radiation treatment course, as well as at&#xD;
             6 weeks follow-up&#xD;
  &#xD;
        Researchers will compare the R&amp;R group (interventional arm) to current conventional DIBH&#xD;
        instruction (standard group) to see if Dmax to the heart decreases and compliance and&#xD;
        satisfaction under patients rises.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Postoperative radiotherapy is widely practiced and highly effective in enabling breast&#xD;
        conserving therapy in early stage tumors, and decreasing recurrence while improving survival&#xD;
        in patients with advanced-stage breast cancer, the most common cancer in women. However,&#xD;
        these benefits of radiotherapy are associated with a long-term risk of cardiac morbidity and&#xD;
        mortality in breast cancer survivors. The unintended cardiac radiation exposure due to the&#xD;
        heart's proximity to the treatment target has been well recognized, particularly in&#xD;
        left-sided breast cancer. Because there is no lowest &quot;safe&quot; threshold radiation dose level&#xD;
        for radiation-induced cardiac complications, the dose to the heart must be kept as low as&#xD;
        possible to reduce the complications risk.&#xD;
  &#xD;
        Recent advances in high-precision 3D conformal and intensity-modulated radiotherapy&#xD;
        techniques have enabled better protection of the heart. Treatment in deep inspiration breath&#xD;
        hold (DIBH) is indispensable to realize these technological capabilities by taking advantage&#xD;
        of the greater distance created between the radiotherapy target and the contralaterally and&#xD;
        inferiorly displaced heart during deep inspiration. While many studies have demonstrated&#xD;
        reduction of the heart dose with DIBH, challenges in decreasing heart dose to a minimum&#xD;
        remain.&#xD;
  &#xD;
        Radiotherapy in DIBH requires active and complex cooperation from the patient, and its&#xD;
        success critically depends on how well patients are capable to perform the prolonged extended&#xD;
        deep breathing maneuver on a repetitive basis every day during their weeks-long treatment&#xD;
        course. Both the physical demands and profound anxiety and stress, which are highly prevalent&#xD;
        in breast cancer patients, additionally interfere with patients' DIBH performance. Anxiety is&#xD;
        well known to directly adversely affect breathing patterns, thereby challenging patients'&#xD;
        ability to perform DIBH optimally.&#xD;
  &#xD;
        Preliminary research explored the role of physical training and showed that targeted DIBH&#xD;
        training improves patients' cooperation and the ease of the DIBH procedure, and reduces the&#xD;
        radiation dose to the heart. However, while DIBH training regimens may improve patients'&#xD;
        physical respiratory skill levels, they do not address their mental stress and anxiety.&#xD;
        Relaxation techniques to alleviate anxiety and stress have been rarely used in complex&#xD;
        radiotherapy procedures, particularly not in DIBH. Preliminary studies in diagnostic&#xD;
        radiology procedures suggest that advanced communication and relaxation techniques, targeted&#xD;
        to relieve anxiety and stress, improve patients' procedural performance, anxiety and comfort.&#xD;
        The investigators hypothesize that implementing both, DIBH Respiratory Training and advanced&#xD;
        communication and Relaxation Training (R&amp;R), improve patients' DIBH performance skills and&#xD;
        further reduce heart dose, while alleviating anxiety and stress and improving quality of life&#xD;
        during and after radiation therapy.&#xD;
  &#xD;
        The investigators propose to test this hypothesis in a clinical trial randomizing R&amp;R vs.&#xD;
        standard-of-care management in patients with radiotherapy in DIBH for left breast cancer. The&#xD;
        investigators primary endpoint will assess heart dose (Dmax), and secondary endpoints include&#xD;
        longitudinal anxiety and quality of life assessment and clinic workflow efficiency. The&#xD;
        ultimate goal of this proposal is to develop a validated patient-centered training and&#xD;
        integrative health regimen to further improve the success of advanced-technology-based&#xD;
        cardiac dose reduction, and improve cardiac health in breast cancer survivors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 22, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>The randomized design of the study will test R&amp;R interventions compared to current conventional DIBH instruction.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change of Dmax to the heart in DIBH under adjuvant radiotherapy of left sided breast cancer</measure>
      <time_frame>during treatment (4 weeks)</time_frame>
      <description>Maximum Dose to the heart (Dmax) in deep inspiration during adjuvant radiotherapy for breast cancer in dependence of the use of communication training and the use of relaxation techniques</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Improving quality of life under radiotherapy of left sided breast cancer</measure>
      <time_frame>- at baseline - during treatment (4 weeks) - at 6 week Follow-Up</time_frame>
      <description>Quality of life outcome measures using a standardized questionnaire including parts of EORTC- Quality of Life-C30 (high score for a functional scale or global health status represent a high level of functioning or a high QoL, a high score for a symptom scale represents a high level of problems; scale: 0 - 100)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improving heart Dmean under radiotherapy of left sided breast cancer</measure>
      <time_frame>during treatment (4 weeks)</time_frame>
      <description>Change in heart Dmean as a measure of cardiac toxicity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improving Left anterior descending (LAD) Dmean under radiotherapy of left sided breast cancer</measure>
      <time_frame>during treatment (4 weeks)</time_frame>
      <description>Change in LAD Dmean as a measure of cardiac toxicity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improving LAD Dmax under radiotherapy of left sided breast cancer</measure>
      <time_frame>during treatment (4 weeks)</time_frame>
      <description>Change in LAD Dmax as a measure of cardiac toxicity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improving left ventricle (LV) Dmean under radiotherapy of left sided breast cancer</measure>
      <time_frame>during treatment (4 weeks)</time_frame>
      <description>Change in LV Dmean as a measure of cardiac toxicity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of clinic workflow metrics under radiotherapy of left sided breast cancer</measure>
      <time_frame>- before start of treatment (one week before planning CT) - during treatment (4 weeks) - at 6 week Follow-Up</time_frame>
      <description>Evaluation of clinic workflow metrics in the radiation oncology unit related to the implementation of DIBH by measuring specific data, such as total treatment time, in comparison with metrics of patients in the control group.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improving patients satisfaction with R&amp;R under radiotherapy of left sided breast cancer</measure>
      <time_frame>- during treatment (4 weeks) - at 6 week Follow-Up</time_frame>
      <description>Patient-reported outcome measures using a standardized questionnaire including parts of EORTC-Qualitiy of Life-BR-23 (Breast Cancer score, higher scores mean a worse outcome; scale: 0-100)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improving radiation dose in organs at risk under radiotherapy of left sided breast cancer</measure>
      <time_frame>during treatment (4 weeks)</time_frame>
      <description>Comparison of radiation doses in organs at risk of structures other than the heart as a criterion for sparing adjacent organs and structures</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">108</enrollment>
    <condition>Radiotherapy</condition>
    <condition>Breast Cancer</condition>
    <condition>Relaxation</condition>
    <condition>Breathholding</condition>
    <arm_group>
      <arm_group_label>R&amp;R arm (interventional arm)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The training program in the experimental arm includes relaxation techniques, breath hold training, music, and nature sounds that patients can listen to on an MP3 player. The training is offered one week before the planning CT scan and patients are encouraged to practice independently. Patients complete standardized questionnaires about their well-being and satisfaction at prospective time points before, during the radiation treatment course, as well as at 6 weeks follow-up.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard arm</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients in the standard arm receive current conventional DIBH instruction without an extended R&amp;R training. Patients complete standardized questionnaires about their well-being and satisfaction at prospective time points before, during the radiation treatment course, as well as at 6 weeks follow-up.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Respiratory training and relaxation techniques under adjuvant radiation therapy in DIBH in breast cancer</intervention_name>
      <description>R&amp;R training provided on an MP3-player for daily practice</description>
      <arm_group_label>R&amp;R arm (interventional arm)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female breast cancer patients&#xD;
  &#xD;
            -  Left sided breast cancer&#xD;
  &#xD;
            -  Treated with surgery prior to radiotherapy&#xD;
  &#xD;
            -  Age &gt;18 years at time of inclusion&#xD;
  &#xD;
            -  WHO performance status 0-1&#xD;
  &#xD;
            -  Planned for radiotherapy alone to the breast, the chest wall and/or the lymph node&#xD;
               areas&#xD;
  &#xD;
            -  Radiotherapy based on planning-CT scan using either 3D-CRT, IMRT, or VMAT/RapidArc&#xD;
  &#xD;
            -  Written Informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;18 years&#xD;
  &#xD;
            -  Pregnancy, Breastfeeding&#xD;
  &#xD;
            -  Previous thoracic or mediastinal radiation&#xD;
  &#xD;
            -  Bilateral breast cancer&#xD;
  &#xD;
            -  Partial breast irradiation&#xD;
  &#xD;
            -  M1 disease (metastatic breast cancer)&#xD;
  &#xD;
            -  Severe lung disease&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Stephanie Combs, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Radiation Oncology, Technical University of Munich</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kai Borm, MD</last_name>
      <phone>0049-89-4140-4501</phone>
      <email>kai.borm@mri.tum.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rebecca Asadpour, MD</last_name>
      <phone>0049-89-4140-4501</phone>
      <email>rebecca.asadpour@mri.tum.de</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Radiation Oncology, Technical University of Munich</name>
        <address>
          <city>Munich</city>
          <zip>81675</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kai Borm, MD</last_name>
        <phone>0049-89-4140-4501</phone>
        <email>kai.borm@mri.tum.de</email>
      </contact>
      <contact_backup>
        <last_name>Rebecca Asadpour, MD</last_name>
        <phone>0049-89-4140-4501</phone>
        <email>rebecca.asadpour@mri.tum.de</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>January 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Adjuvant radiotherapy for Breast Cancer</keyword>
    <keyword>DIBH in left sided Breast Cancer</keyword>
    <keyword>Respiratory and Relaxation Techniques</keyword>
    <keyword>patients compliance</keyword>
    <keyword>active participation under radiotherapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05975190
  org study id: 2020-277_1-S-NP
  nct id: NCT05975190
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this prospective clinical trial is to improve patient compliance and performance
        of deep inspiration breath hold (DIBH) to further reduce the cardiac dose from left breast
        radiation, and to improve cooperation and patient satisfaction through an active and formal
        pre-treatment respiratory training program combined with relaxation training (R&R) in breast
        cancer patients undergoing adjuvant radiotherapy for left sided breast cancer.
  
        The main questions the study aims to answer are:
  
          -  Does the use of communication training and the use of relaxation techniques (R&R) reduce
             the Maximum dose to the heart (Dmax) and improve further heart dose parameters in deep
             inspiration during adjuvant radiotherapy for breast cancer?
  
          -  Does R&R improve longitudinal anxiety and quality of life under patients undergoing DIBH
             adjuvant radiotherapy for left sided breast cancer?
  
        Participants will be randomly assigned to either an experimental arm, which will receive the
        R&R, versus a standard arm that will not receive the R&R.
  
          -  training program in the experimental arm includes breath hold training, music, and
             nature sounds that patients can listen to on an MP3 player
  
          -  both groups complete standardized questionnaires about their well-being and satisfaction
             at prospective time points before, during the radiation treatment course, as well as at
             6 weeks follow-up
  
        Researchers will compare the R&R group (interventional arm) to current conventional DIBH
        instruction (standard group) to see if Dmax to the heart decreases and compliance and
        satisfaction under patients rises.
  Postoperative radiotherapy is widely practiced and highly effective in enabling breast
        conserving therapy in early stage tumors, and decreasing recurrence while improving survival
        in patients with advanced-stage breast cancer, the most common cancer in women. However,
        these benefits of radiotherapy are associated with a long-term risk of cardiac morbidity and
        mortality in breast cancer survivors. The unintended cardiac radiation exposure due to the
        heart's proximity to the treatment target has been well recognized, particularly in
        left-sided breast cancer. Because there is no lowest "safe" threshold radiation dose level
        for radiation-induced cardiac complications, the dose to the heart must be kept as low as
        possible to reduce the complications risk.
  
        Recent advances in high-precision 3D conformal and intensity-modulated radiotherapy
        techniques have enabled better protection of the heart. Treatment in deep inspiration breath
        hold (DIBH) is indispensable to realize these technological capabilities by taking advantage
        of the greater distance created between the radiotherapy target and the contralaterally and
        inferiorly displaced heart during deep inspiration. While many studies have demonstrated
        reduction of the heart dose with DIBH, challenges in decreasing heart dose to a minimum
        remain.
  
        Radiotherapy in DIBH requires active and complex cooperation from the patient, and its
        success critically depends on how well patients are capable to perform the prolonged extended
        deep breathing maneuver on a repetitive basis every day during their weeks-long treatment
        course. Both the physical demands and profound anxiety and stress, which are highly prevalent
        in breast cancer patients, additionally interfere with patients' DIBH performance. Anxiety is
        well known to directly adversely affect breathing patterns, thereby challenging patients'
        ability to perform DIBH optimally.
  
        Preliminary research explored the role of physical training and showed that targeted DIBH
        training improves patients' cooperation and the ease of the DIBH procedure, and reduces the
        radiation dose to the heart. However, while DIBH training regimens may improve patients'
        physical respiratory skill levels, they do not address their mental stress and anxiety.
        Relaxation techniques to alleviate anxiety and stress have been rarely used in complex
        radiotherapy procedures, particularly not in DIBH. Preliminary studies in diagnostic
        radiology procedures suggest that advanced communication and relaxation techniques, targeted
        to relieve anxiety and stress, improve patients' procedural performance, anxiety and comfort.
        The investigators hypothesize that implementing both, DIBH Respiratory Training and advanced
        communication and Relaxation Training (R&R), improve patients' DIBH performance skills and
        further reduce heart dose, while alleviating anxiety and stress and improving quality of life
        during and after radiation therapy.
  
        The investigators propose to test this hypothesis in a clinical trial randomizing R&R vs.
        standard-of-care management in patients with radiotherapy in DIBH for left breast cancer. The
        investigators primary endpoint will assess heart dose (Dmax), and secondary endpoints include
        longitudinal anxiety and quality of life assessment and clinic workflow efficiency. The
        ultimate goal of this proposal is to develop a validated patient-centered training and
        integrative health regimen to further improve the success of advanced-technology-based
        cardiac dose reduction, and improve cardiac health in breast cancer survivors.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The randomized design of the study will test R&R interventions compared to current conventional DIBH instruction.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change of Dmax to the heart in DIBH under adjuvant radiotherapy of left sided breast cancer
  time frame: during treatment (4 weeks)
  description: Maximum Dose to the heart (Dmax) in deep inspiration during adjuvant radiotherapy for breast cancer in dependence of the use of communication training and the use of relaxation techniques
  measure: Improving quality of life under radiotherapy of left sided breast cancer
  time frame: - at baseline - during treatment (4 weeks) - at 6 week Follow-Up
  description: Quality of life outcome measures using a standardized questionnaire including parts of EORTC- Quality of Life-C30 (high score for a functional scale or global health status represent a high level of functioning or a high QoL, a high score for a symptom scale represents a high level of problems; scale: 0 - 100)
  measure: Improving heart Dmean under radiotherapy of left sided breast cancer
  time frame: during treatment (4 weeks)
  description: Change in heart Dmean as a measure of cardiac toxicity
  measure: Improving Left anterior descending (LAD) Dmean under radiotherapy of left sided breast cancer
  time frame: during treatment (4 weeks)
  description: Change in LAD Dmean as a measure of cardiac toxicity
  measure: Improving LAD Dmax under radiotherapy of left sided breast cancer
  time frame: during treatment (4 weeks)
  description: Change in LAD Dmax as a measure of cardiac toxicity
  measure: Improving left ventricle (LV) Dmean under radiotherapy of left sided breast cancer
  time frame: during treatment (4 weeks)
  description: Change in LV Dmean as a measure of cardiac toxicity
  measure: Evaluation of clinic workflow metrics under radiotherapy of left sided breast cancer
  time frame: - before start of treatment (one week before planning CT) - during treatment (4 weeks) - at 6 week Follow-Up
  description: Evaluation of clinic workflow metrics in the radiation oncology unit related to the implementation of DIBH by measuring specific data, such as total treatment time, in comparison with metrics of patients in the control group.
  measure: Improving patients satisfaction with R&R under radiotherapy of left sided breast cancer
  time frame: - during treatment (4 weeks) - at 6 week Follow-Up
  description: Patient-reported outcome measures using a standardized questionnaire including parts of EORTC-Qualitiy of Life-BR-23 (Breast Cancer score, higher scores mean a worse outcome; scale: 0-100)
  measure: Improving radiation dose in organs at risk under radiotherapy of left sided breast cancer
  time frame: during treatment (4 weeks)
  description: Comparison of radiation doses in organs at risk of structures other than the heart as a criterion for sparing adjacent organs and structures
  arm group label: R&R arm (interventional arm)
  arm group type: Experimental
  description: The training program in the experimental arm includes relaxation techniques, breath hold training, music, and nature sounds that patients can listen to on an MP3 player. The training is offered one week before the planning CT scan and patients are encouraged to practice independently. Patients complete standardized questionnaires about their well-being and satisfaction at prospective time points before, during the radiation treatment course, as well as at 6 weeks follow-up.
  arm group label: Standard arm
  arm group type: No Intervention
  description: Patients in the standard arm receive current conventional DIBH instruction without an extended R&R training. Patients complete standardized questionnaires about their well-being and satisfaction at prospective time points before, during the radiation treatment course, as well as at 6 weeks follow-up.
  intervention type: Other
  intervention name: Respiratory training and relaxation techniques under adjuvant radiation therapy in DIBH in breast cancer
  description: R&R training provided on an MP3-player for daily practice
  arm group label: R&R arm (interventional arm)
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Stephanie Combs, MD
  role: Principal Investigator
  affiliation: Department of Radiation Oncology, Technical University of Munich
  last name: Kai Borm, MD
  phone: 0049-89-4140-4501
  email: kai.borm@mri.tum.de
  last name: Rebecca Asadpour, MD
  phone: 0049-89-4140-4501
  email: rebecca.asadpour@mri.tum.de
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Germany
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  sharing ipd: No