<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/NCT03269981</url>
  </required_header>
  <id_info>
    <org_study_id>SMC 2017-01-085-001</org_study_id>
    <nct_id>NCT03269981</nct_id>
  </id_info>
  <brief_title>Randomized Study of Elective Regional Lymph Node Irradiation in N1 Breast Cancer</brief_title>
  <official_title>A Phase III Prospective Randomized Study of Elective Regional Lymph Node Irradiation in Pathologic N1 Breast Cancer Patients Treated With Breast Conserving Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Korean Radiation Oncology Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health, Republic of Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the impact of elective regional lymph node irradiation on N1 breast&#xD;
      cancer patients receiving post-lumpectomy radiotherapy and anthracycline plus taxane&#xD;
      (AT)-based chemotherapy. We randomly assign patients having one to three metastatic lymph&#xD;
      nodes (pN1) after breast-conserving surgery (BCS) and AT-based chemotherapy to undergo either&#xD;
      whole-breast and regional nodal irradiation (WB+RNI group) or whole-breast irradiation alone&#xD;
      (WBI group).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective:&#xD;
&#xD;
        -  Compare the effect of post-BCS WBI vs. WB+RNI on disease-free survival in pN1 breast&#xD;
           cancer patients who received AT-based chemotherapy.&#xD;
&#xD;
        -  Evaluate the impact of WBI or WB+RNI according to molecular subtype of tumor.&#xD;
&#xD;
        -  Compare the treatment-related toxicities between the WBI and WB+RNI.&#xD;
&#xD;
        -  Compare the patient's quality of life between the WBI and WB+RNI.&#xD;
&#xD;
      Outline: This is a a randomized, multi-center, phase III study. Patients are stratified&#xD;
      according to molecular subtype of tumor (luminal A vs luminal vs luminal HER2 vs&#xD;
      HER2-enriched vs basal-like), axillary lymph node management (sentinel lymph node biopsy&#xD;
      [SLN] only vs axillary lymph node dissection+/- SLN) and participating institutions. Patients&#xD;
      are randomized to one of two treatment arms.&#xD;
&#xD;
        -  Arm I: Patients receive WB+RNI.&#xD;
&#xD;
        -  Arm II: Patients receive WBI alone.&#xD;
&#xD;
      Arm circumference and quality of life (EORTC QLQ-C30 &amp; EORTC QLQ-BR23) are assessed within 2&#xD;
      weeks prior to randomization, during the last week of radiotherapy, at 3 months after&#xD;
      completion of radiotherapy, and then annually thereafter for five years.&#xD;
&#xD;
      Patients are followed at 3 months after completion of radiotherapy and annually thereafter&#xD;
      for seven years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2029</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2022</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>7 years</time_frame>
    <description>Disease-free survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival according to molecular subtype</measure>
    <time_frame>5 years</time_frame>
    <description>Disease-free survival according to molecular subtype</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment-related toxicity</measure>
    <time_frame>5 years</time_frame>
    <description>acute and chronic toxicities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Organization for Research and Treatment of Cancer (EORTC)-Quality of life. Questionnaire 30 (QLQ-C30) measurement</measure>
    <time_frame>5 years</time_frame>
    <description>1 (Not at all) to 4 (Very much), 1 (Very poor) to 7 (Excellent). For functional and global quality of life scales, higher scores mean a better level of functioning. For symptom-oriented scales, a higher score means more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR23) measurement</measure>
    <time_frame>5 years</time_frame>
    <description>1 (Not at all) to 4 (Very much). A higher score means more severe symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">827</enrollment>
  <condition>Breast Neoplasm</condition>
  <arm_group>
    <arm_group_label>Whole breast irradiation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Post-lumpectomy radiotherapy to the whole breast alone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Whole breast and nodal irradiation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Post-lumpectomy radiotherapy to the whole breast and regional lymph node.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Whole breast irradiation</intervention_name>
    <description>Radiotherapy to the whole breast alone.</description>
    <arm_group_label>Whole breast irradiation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Whole breast and nodal irradiation</intervention_name>
    <description>Radiotherapy to the whole breast and regional lymph nodes.</description>
    <arm_group_label>Whole breast and nodal irradiation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven invasive carcinoma of the breast.&#xD;
&#xD;
          -  One to three positive axillary lymph nodes (pN1) proven in pathologic specimen.&#xD;
&#xD;
          -  Prior breast-conserving surgery and post-operative adjuvant chemotherapy including&#xD;
             taxane.&#xD;
&#xD;
          -  Administering adjuvant hormonal therapy in cases with hormone receptor-positive tumor.&#xD;
&#xD;
          -  Administering anti-HER2 therapy in cases with HER2-positive tumor.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metastases in supraclavicular or internal mammary lymph nodes.&#xD;
&#xD;
          -  Metastases in distant organs.&#xD;
&#xD;
          -  Neoadjuvant chemotherapy or hormone therapy before surgery.&#xD;
&#xD;
          -  Not receiving adjuvant anthracycline and taxane.&#xD;
&#xD;
          -  Bilateral breast cancer&#xD;
&#xD;
          -  Previous history of radiotherapy of the ipsilateral breast or supraclavicular lymph&#xD;
             nodes.&#xD;
&#xD;
          -  Prior history of other types of cancer, except thyroid cancer, carcinoma in situ of&#xD;
             the cervix, or skin cancer.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Won Park, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>July 10, 2022</last_update_submitted>
  <last_update_submitted_qc>July 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adjuvant radiotherapy</keyword>
  <keyword>Lymphatic irradiation</keyword>
  <keyword>Taxane</keyword>
  <keyword>Anthracycline</keyword>
  <keyword>Prospective study</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/NCT03269981
org study id: SMC 2017-01-085-001
nct id: NCT03269981
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates the impact of elective regional lymph node irradiation on N1 breast
      cancer patients receiving post-lumpectomy radiotherapy and anthracycline plus taxane
      (AT)-based chemotherapy. We randomly assign patients having one to three metastatic lymph
      nodes (pN1) after breast-conserving surgery (BCS) and AT-based chemotherapy to undergo either
      whole-breast and regional nodal irradiation (WB+RNI group) or whole-breast irradiation alone
      (WBI group).
Objective:

        -  Compare the effect of post-BCS WBI vs. WB+RNI on disease-free survival in pN1 breast
           cancer patients who received AT-based chemotherapy.

        -  Evaluate the impact of WBI or WB+RNI according to molecular subtype of tumor.

        -  Compare the treatment-related toxicities between the WBI and WB+RNI.

        -  Compare the patient's quality of life between the WBI and WB+RNI.

      Outline: This is a a randomized, multi-center, phase III study. Patients are stratified
      according to molecular subtype of tumor (luminal A vs luminal vs luminal HER2 vs
      HER2-enriched vs basal-like), axillary lymph node management (sentinel lymph node biopsy
      [SLN] only vs axillary lymph node dissection+/- SLN) and participating institutions. Patients
      are randomized to one of two treatment arms.

        -  Arm I: Patients receive WB+RNI.

        -  Arm II: Patients receive WBI alone.

      Arm circumference and quality of life (EORTC QLQ-C30 & EORTC QLQ-BR23) are assessed within 2
      weeks prior to randomization, during the last week of radiotherapy, at 3 months after
      completion of radiotherapy, and then annually thereafter for five years.

      Patients are followed at 3 months after completion of radiotherapy and annually thereafter
      for seven years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease-free survival
time frame: 7 years
description: Disease-free survival
measure: Disease-free survival according to molecular subtype
time frame: 5 years
description: Disease-free survival according to molecular subtype
measure: Treatment-related toxicity
time frame: 5 years
description: acute and chronic toxicities
measure: European Organization for Research and Treatment of Cancer (EORTC)-Quality of life. Questionnaire 30 (QLQ-C30) measurement
time frame: 5 years
description: 1 (Not at all) to 4 (Very much), 1 (Very poor) to 7 (Excellent). For functional and global quality of life scales, higher scores mean a better level of functioning. For symptom-oriented scales, a higher score means more severe symptoms.
measure: EORTC Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR23) measurement
time frame: 5 years
description: 1 (Not at all) to 4 (Very much). A higher score means more severe symptoms.
arm group label: Whole breast irradiation
arm group type: Experimental
description: Post-lumpectomy radiotherapy to the whole breast alone.
arm group label: Whole breast and nodal irradiation
arm group type: Active Comparator
description: Post-lumpectomy radiotherapy to the whole breast and regional lymph node.
intervention type: Radiation
intervention name: Whole breast irradiation
description: Radiotherapy to the whole breast alone.
arm group label: Whole breast irradiation
intervention type: Radiation
intervention name: Whole breast and nodal irradiation
description: Radiotherapy to the whole breast and regional lymph nodes.
arm group label: Whole breast and nodal irradiation
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Won Park, MD
role: Study Chair
affiliation: Samsung Medical Center
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Undecided