<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/NCT03829553</url>
  </required_header>
  <id_info>
    <org_study_id>RJBC-HFRNI</org_study_id>
    <nct_id>NCT03829553</nct_id>
  </id_info>
  <brief_title>Hypofractionated Irradiation At Regional Nodal Area for Breast Cancer Vs Existed Standard Treatment</brief_title>
  <acronym>HARVEST</acronym>
  <official_title>Hypofractionated Versus Conventional Intensity-Modulated Radiation Therapy for Breast Cancer Patients With an Indication for Regional Nodal Irradiation: A Randomized Multi-center Phase III Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai 10th People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Affiliated Hospital of Jiangnan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ruijin Hospital</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 main objective of this trial is to investigate the efficacy and safety of&#xD;
      hypofractionated radiotherapy of 3 or 4 weeks by comparing with conventional radiotherapy of&#xD;
      5 or 6 weeks using intensity-modulated radiation therapy (IMRT) in breast cancer patients&#xD;
      with an indication for regional nodal irradiation (RNI) following mastectomy or breast&#xD;
      conserving surgery. Patients will be randomized to hypofractionated radiotherapy or&#xD;
      conventional radiotherapy delivered to chest wall or whole breast and regional lymph regions&#xD;
      (including supraclavicular and internal mammary lymph nodes). Eligible breast cancer patients&#xD;
      will be followed for at least 5 years to evaluate the difference in 5-year locoregional&#xD;
      recurrence, over survival, distant metastasis, toxicity and life quality between two groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators hypothesize that hypofractionated radiotherapy is equally effective and safe as&#xD;
      conventional radiotherapy in breast cancer patients with an indication for regional nodal&#xD;
      irradiation. Eligible breast cancer patients are randomized 1:1 into the following two&#xD;
      groups: hypofractionated radiotherapy of 2.67 Gy for 16 fractions (and sequential tumor bed&#xD;
      boost of 2.67 Gy for 4 fractions in patients with intact breast) and conventional&#xD;
      radiotherapy of 2Gy for 25 fractions (and sequential tumor bed boost of 2 Gy for 5 fractions&#xD;
      in patients with intact breast). The dose was prescribed to ipsilateral chest wall or whole&#xD;
      breast and regional lymph regions (including supraclavicular and internal mammary lymph&#xD;
      nodes). All patients are treated with IMRT. The primary endpoint is locoregional recurrence.&#xD;
      Patients will be followed at least 5 years after radiotherapy to evaluated over survival,&#xD;
      distant metastasis, toxicity and life quality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 21, 2019</start_date>
  <completion_date type="Anticipated">December 2027</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Locoregional recurrence (LRR)</measure>
    <time_frame>5 years</time_frame>
    <description>any first recurrence confirmed by histology or cytology in the ipsilateral chest wall or breast or regional nodes areas (including axillary, supraclavicular, infraclavicular lymph nodes or IMN)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distant metastasis free survival (DMFS)</measure>
    <time_frame>5 years</time_frame>
    <description>the time from the date of randomization to any recurrence of tumor at distant sites or death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Invasive recurrence-free survival (IRFS)</measure>
    <time_frame>5 year</time_frame>
    <description>the time from the date of randomization to any invasive recurrence of tumor, distant metastases or death from any cause and second invasive primaries, including invasive neoplasms of the breast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>over survival (OS)</measure>
    <time_frame>5 years</time_frame>
    <description>the time from the date of randomization to the date of death from any cause or end of the follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/NSABP/RTOG scoring scale</measure>
    <time_frame>5 years</time_frame>
    <description>The time from the date of randomization to 5 years after completion of radiotherapy, the cosmetic outcomes will be evaluated before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/(National Surgical Adjuvant Breast and Bowel Project) NSABP/ (Radiation Therapy Oncology Group) RTOG scoring scale which graded patients into the following four classifications: excellent, when compared to the untreated breast, there is a minimal or no difference in the size or shape of the treated breast; good, slight difference in the size or shape of the treated breast; fair, obvious difference in the size or shape of the treated breast; and poor, marked change in the size or shape of the treated breast.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with ≥Grade1 Acute Radiation-induced Toxicity</measure>
    <time_frame>6 months</time_frame>
    <description>within time from beginning of RT to 6 months after completion of RT assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with ≥Grade1 Late Radiation-induced Toxicity</measure>
    <time_frame>5 years</time_frame>
    <description>within time from 6 months after completion of RT to 5 years after completion of RT assessed according to the RTOG/ European Organization for Research on Treatment of Cancer (EORTC） Late Radiation Morbidity Scoring Schema and CTCAE version 3.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reconstruction complications</measure>
    <time_frame>5 years</time_frame>
    <description>number of participants with any reconstruction complications (flap necrosis, capsular contracture, infection, loss of implant/expander or flaps, et al) and the interval between the RT and reconstruction complications will be recorded. Patient reported outcome with reconstruction will be evaluated by Breast-Q questionnaires before RT and 12 months after RT.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of Life-EORTC QLQ-C30</measure>
    <time_frame>1 years</time_frame>
    <description>The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-C30</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of Life-EORTC QLQ-C30</measure>
    <time_frame>5 years</time_frame>
    <description>The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-C30</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of Life-EORTC QLQ-BR23</measure>
    <time_frame>1 years</time_frame>
    <description>The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-BR23</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of Life-EORTC QLQ-BR23</measure>
    <time_frame>5 years</time_frame>
    <description>The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-BR23</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">801</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Hypofractionated radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with an indication for regional nodal irradiation will received 2.67 Gy for 16 fractions to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67 Gy for 4 fractions following breast conserving surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional radiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with an indication for regional nodal irradiation will received 2 Gy for 25 fractions to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2 Gy for 5 fractions following breast conserving surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Hypofractionated radiotherapy</intervention_name>
    <description>4005 cGy/ 15 fractions / 3 weeks to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67Gy for 4 fractions in patients with intact breast</description>
    <arm_group_label>Hypofractionated radiotherapy</arm_group_label>
    <other_name>Experimental Arm</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Conventional radiotherapy</intervention_name>
    <description>5000 cGy/ 25 fractions / 5 weeks ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2Gy for 5 fractions in patients with intact breast</description>
    <arm_group_label>Conventional radiotherapy</arm_group_label>
    <other_name>Active Comparator Arm</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Age 18-75 years old&#xD;
&#xD;
          -  unilateral histologically confirmed invasive breast carcinoma of pT1-3&#xD;
&#xD;
          -  breast conservation surgery or mastectomy&#xD;
&#xD;
          -  Breast reconstruction is allowed&#xD;
&#xD;
          -  histologically confirmed positive axillary lymph nodes (positive sentinel lymph nodes&#xD;
             without axillary dissection is allowed)&#xD;
&#xD;
          -  Life expectancy of &gt;5 years&#xD;
&#xD;
          -  A minimum negative surgical margin width of &gt;2mm&#xD;
&#xD;
          -  Karnofsky Performance Status ≥80&#xD;
&#xD;
          -  Estrogen-receptor, Progesterone-receptor, human epidermal growth factor receptor-2&#xD;
             (HER-2) and Ki67 index can be performed on the primary breast tumor or axillary nodes.&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Supraclavicular lymph nodes, positive ipsilateral internal mammary lymph nodes or&#xD;
             residual axillary nodes that may be eligible for a boost dose.&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Severe non-neoplastic medical comorbidities&#xD;
&#xD;
          -  Diagnosis of non-breast malignancy within 5 years preceding enrollment (except for&#xD;
             basal cell carcinoma of the skin or carcinoma in situ of the cervix).&#xD;
&#xD;
          -  Simultaneous contralateral breast cancer&#xD;
&#xD;
          -  Previous RT to thoracic and/or axillary, cervical region&#xD;
&#xD;
          -  Active collagen vascular disease&#xD;
&#xD;
          -  Evidence of distant metastatic disease and/or T4 disease&#xD;
&#xD;
        Notes for exlusion criteria:&#xD;
&#xD;
          1. Patients with severe non-neoplastic medical comorbidities (e.g.,severe ischemic heart&#xD;
             disease, severe arrhythmia or severe chronic obstructive pulmonary disease ) that&#xD;
             would preclude radiation treatment will be excluded.&#xD;
&#xD;
          2. Simultaneous contralateral breast cancer includes histologically confirmed DCIS only.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jia-Yi Chen</last_name>
    <role>Study Chair</role>
    <affiliation>Ruijin Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jia-Yi Chen</last_name>
    <phone>+86-021-64370045</phone>
    <phone_ext>602400</phone_ext>
    <email>chenjiayi0188@aliyun.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jia-Yi Chen, M.D.</last_name>
      <phone>+86-021-64370045</phone>
      <phone_ext>602400</phone_ext>
      <email>chenjiayi0188@aliyun.com</email>
    </contact>
    <contact_backup>
      <last_name>Jia-Yi Chen, M.D</last_name>
      <phone>+86-021-64370045</phone>
      <phone_ext>602400</phone_ext>
      <email>chenjiayi0188@aliyun.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>May 29, 2022</last_update_submitted>
  <last_update_submitted_qc>May 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
    <investigator_full_name>Jiayi Chen</investigator_full_name>
    <investigator_title>Chief of Department of Radiation Oncology</investigator_title>
  </responsible_party>
  <keyword>regional nodal irradiation</keyword>
  <keyword>IMRT</keyword>
  <keyword>Hypofractionated 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>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03829553
org study id: RJBC-HFRNI
nct id: NCT03829553
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of this trial is to investigate the efficacy and safety of
      hypofractionated radiotherapy of 3 or 4 weeks by comparing with conventional radiotherapy of
      5 or 6 weeks using intensity-modulated radiation therapy (IMRT) in breast cancer patients
      with an indication for regional nodal irradiation (RNI) following mastectomy or breast
      conserving surgery. Patients will be randomized to hypofractionated radiotherapy or
      conventional radiotherapy delivered to chest wall or whole breast and regional lymph regions
      (including supraclavicular and internal mammary lymph nodes). Eligible breast cancer patients
      will be followed for at least 5 years to evaluate the difference in 5-year locoregional
      recurrence, over survival, distant metastasis, toxicity and life quality between two groups.
Investigators hypothesize that hypofractionated radiotherapy is equally effective and safe as
      conventional radiotherapy in breast cancer patients with an indication for regional nodal
      irradiation. Eligible breast cancer patients are randomized 1:1 into the following two
      groups: hypofractionated radiotherapy of 2.67 Gy for 16 fractions (and sequential tumor bed
      boost of 2.67 Gy for 4 fractions in patients with intact breast) and conventional
      radiotherapy of 2Gy for 25 fractions (and sequential tumor bed boost of 2 Gy for 5 fractions
      in patients with intact breast). The dose was prescribed to ipsilateral chest wall or whole
      breast and regional lymph regions (including supraclavicular and internal mammary lymph
      nodes). All patients are treated with IMRT. The primary endpoint is locoregional recurrence.
      Patients will be followed at least 5 years after radiotherapy to evaluated over survival,
      distant metastasis, toxicity and life quality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Locoregional recurrence (LRR)
time frame: 5 years
description: any first recurrence confirmed by histology or cytology in the ipsilateral chest wall or breast or regional nodes areas (including axillary, supraclavicular, infraclavicular lymph nodes or IMN)
measure: Distant metastasis free survival (DMFS)
time frame: 5 years
description: the time from the date of randomization to any recurrence of tumor at distant sites or death from any cause.
measure: Invasive recurrence-free survival (IRFS)
time frame: 5 year
description: the time from the date of randomization to any invasive recurrence of tumor, distant metastases or death from any cause and second invasive primaries, including invasive neoplasms of the breast.
measure: over survival (OS)
time frame: 5 years
description: the time from the date of randomization to the date of death from any cause or end of the follow-up.
measure: Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/NSABP/RTOG scoring scale
time frame: 5 years
description: The time from the date of randomization to 5 years after completion of radiotherapy, the cosmetic outcomes will be evaluated before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/(National Surgical Adjuvant Breast and Bowel Project) NSABP/ (Radiation Therapy Oncology Group) RTOG scoring scale which graded patients into the following four classifications: excellent, when compared to the untreated breast, there is a minimal or no difference in the size or shape of the treated breast; good, slight difference in the size or shape of the treated breast; fair, obvious difference in the size or shape of the treated breast; and poor, marked change in the size or shape of the treated breast.
measure: Number of Participants with ≥Grade1 Acute Radiation-induced Toxicity
time frame: 6 months
description: within time from beginning of RT to 6 months after completion of RT assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
measure: Number of Participants with ≥Grade1 Late Radiation-induced Toxicity
time frame: 5 years
description: within time from 6 months after completion of RT to 5 years after completion of RT assessed according to the RTOG/ European Organization for Research on Treatment of Cancer (EORTC） Late Radiation Morbidity Scoring Schema and CTCAE version 3.0
measure: Reconstruction complications
time frame: 5 years
description: number of participants with any reconstruction complications (flap necrosis, capsular contracture, infection, loss of implant/expander or flaps, et al) and the interval between the RT and reconstruction complications will be recorded. Patient reported outcome with reconstruction will be evaluated by Breast-Q questionnaires before RT and 12 months after RT.
measure: Quality of Life-EORTC QLQ-C30
time frame: 1 years
description: The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-C30
measure: Quality of Life-EORTC QLQ-C30
time frame: 5 years
description: The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-C30
measure: Quality of Life-EORTC QLQ-BR23
time frame: 1 years
description: The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-BR23
measure: Quality of Life-EORTC QLQ-BR23
time frame: 5 years
description: The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-BR23
arm group label: Hypofractionated radiotherapy
arm group type: Experimental
description: Patients with an indication for regional nodal irradiation will received 2.67 Gy for 16 fractions to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67 Gy for 4 fractions following breast conserving surgery
arm group label: Conventional radiotherapy
arm group type: Active Comparator
description: Patients with an indication for regional nodal irradiation will received 2 Gy for 25 fractions to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2 Gy for 5 fractions following breast conserving surgery.
intervention type: Radiation
intervention name: Hypofractionated radiotherapy
description: 4005 cGy/ 15 fractions / 3 weeks to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67Gy for 4 fractions in patients with intact breast
arm group label: Hypofractionated radiotherapy
other name: Experimental Arm
intervention type: Radiation
intervention name: Conventional radiotherapy
description: 5000 cGy/ 25 fractions / 5 weeks ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2Gy for 5 fractions in patients with intact breast
arm group label: Conventional radiotherapy
other name: Active Comparator Arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jia-Yi Chen
role: Study Chair
affiliation: Ruijin Hospital
last name: Jia-Yi Chen
phone: +86-021-64370045
phone ext: 602400
email: chenjiayi0188@aliyun.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Ruijin Hospital
investigator full name: Jiayi Chen
investigator title: Chief of Department of Radiation Oncology
mesh term: Breast Neoplasms
sharing ipd: Undecided