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/NCT05970107</url>
    </required_header>
    <id_info>
      <org_study_id>CASE2123</org_study_id>
      <nct_id>NCT05970107</nct_id>
    </id_info>
    <brief_title>Axillary Node Dissection w or w/o LVB in Node Positive Breast Cancer Patients</brief_title>
    <official_title>A Prospective Randomized Trial of Axillary Node Dissection With or Without Lymphaticovenous Bypass (LVB) in Node Positive Breast Cancer Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Case Comprehensive Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Case Comprehensive Cancer Center</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Lymphedema is a devastating complication of breast cancer surgery that decreases the quality&#xD;
        of life of up to 40% of breast cancer survivors. Most lymphedema in breast cancer patients is&#xD;
        because lymphatics shared between the axilla and the arm are sacrificed during axillary lymph&#xD;
        node dissection (ALND) surgery, which removes an average of 15 lymph nodes in node positive&#xD;
        patients. CCF's breast cancer plastic microvascular surgeons and breast surgical oncologists&#xD;
        have collaborated to refine a surgical technique known as LVB that may be used either as a&#xD;
        preventive measure (prophylactic LVB) or as a therapeutic intervention (therapeutic LVB).&#xD;
        Lymphatic reconstruction with LVB may be an improvement to the current standard of care for&#xD;
        node positive breast cancer patients undergoing ALND.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2026</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of lymphedema onset after prophylactic LVB-Objective Criteria</measure>
      <time_frame>At month 4 post treatment</time_frame>
      <description>This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline.&#xD;
  The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of lymphedema onset after prophylactic LVB-Objective Criteria</measure>
      <time_frame>At month 8 post treatment</time_frame>
      <description>This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline.&#xD;
  The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of lymphedema onset after prophylactic LVB-Objective Criteria</measure>
      <time_frame>At month 12 post treatment</time_frame>
      <description>This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline.&#xD;
  The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of lymphedema onset after prophylactic LVB-Objective Criteria</measure>
      <time_frame>At month 16 post treatment</time_frame>
      <description>This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline.&#xD;
  The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of lymphedema onset after prophylactic LVB-Objective Criteria</measure>
      <time_frame>At month 20 post treatment</time_frame>
      <description>This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline.&#xD;
  The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of lymphedema onset after prophylactic LVB-Objective Criteria</measure>
      <time_frame>At month 24 post treatment</time_frame>
      <description>This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline.&#xD;
  The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of lymphedema onset after prophylactic LVB-Objective Criteria</measure>
      <time_frame>At month 27 post treatment</time_frame>
      <description>This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline.&#xD;
  The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of lymphedema onset after prophylactic LVB-Subjective Criteria</measure>
      <time_frame>At month 4 post treatment</time_frame>
      <description>The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of lymphedema onset after prophylactic LVB-Subjective Criteria</measure>
      <time_frame>At month 8 post treatment</time_frame>
      <description>The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of lymphedema onset after prophylactic LVB-Subjective Criteria</measure>
      <time_frame>At month 12 post treatment</time_frame>
      <description>The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of lymphedema onset after prophylactic LVB-Subjective Criteria</measure>
      <time_frame>At month 16 post treatment</time_frame>
      <description>The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of lymphedema onset after prophylactic LVB-Subjective Criteria</measure>
      <time_frame>At month 20 post treatment</time_frame>
      <description>The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of lymphedema onset after prophylactic LVB-Subjective Criteria</measure>
      <time_frame>At month 24 post treatment</time_frame>
      <description>The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of lymphedema onset after prophylactic LVB-Subjective Criteria</measure>
      <time_frame>At month 27 post treatment</time_frame>
      <description>The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Node-positive Breast Cancer</condition>
    <arm_group>
      <arm_group_label>ALND + LVB</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The prophylactic LVB cohort will undergo ALND plus ARM and immediate lymphatic reconstruction with lymphaticovenous bypass (LVB). During the ALND, axillary reverse mapping will be used to visualize the lymphatics draining into the axilla, to aid in preserving the draining lymphatic vessels for anastomosis in LVB.&#xD;
  Radiation therapy will be administered as determined by the treating radiation oncologist.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ALND without LVB</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients in the ALND alone cohort will undergo ALND plus ARM&#xD;
  Radiation therapy will be administered as determined by the treating radiation oncologist.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Axillary Lymph Node Dissection</intervention_name>
      <description>ALND happens after cancer cells are found during a sentinel lymph node biopsy.&#xD;
  ALND can remove lymph nodes located above, below or directly underneath a muscle that runs along the side of the upper chest.</description>
      <arm_group_label>ALND + LVB</arm_group_label>
      <arm_group_label>ALND without LVB</arm_group_label>
      <other_name>ALND</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Axillary Reverse Mapping</intervention_name>
      <description>Axillary reverse mapping (ARM) is a technique where blue dye is injected into the upper arm at surgery, allowing direct visualization of arm lymphatics and nodes during ALND</description>
      <arm_group_label>ALND + LVB</arm_group_label>
      <arm_group_label>ALND without LVB</arm_group_label>
      <other_name>ARM</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Lymphaticovenous Bypass</intervention_name>
      <description>Lymphaticovenous bypass/anastomosis (LVB/LVA) involves supramicrosurgery in which the blocked lymphatic vessel of an affected limb is connected to a nearby vein with the aid of ultra-fine instruments and a powerful operating microscope.</description>
      <arm_group_label>ALND + LVB</arm_group_label>
      <other_name>LVB</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects must have histologically or cytologically confirmed axillary node positive&#xD;
               unilateral breast cancer and may be female or male.&#xD;
  &#xD;
            -  Subjects must have received no prior surgical interventions to the axilla except for&#xD;
               core needle biopsy or sentinel node biopsy within 30 days of the planned axillary node&#xD;
               dissection.&#xD;
  &#xD;
            -  Age &gt;18 years. Children are excluded from this study since breast cancer is quite rare&#xD;
               in children.&#xD;
  &#xD;
            -  ECOG Performance status 0 or 1&#xD;
  &#xD;
            -  Subjects must have normal organ and marrow function as defined below:&#xD;
  &#xD;
                 -  Leukocytes ≥ 3,000/mcL&#xD;
  &#xD;
                 -  Absolute neutrophil count ≥ 1,500/mcL&#xD;
  &#xD;
                 -  Platelet count ≥ 100,000/mcL&#xD;
  &#xD;
                 -  Total bilirubin within normal institutional limits&#xD;
  &#xD;
                 -  AST (SGOT) ≤ 2.5 X institutional upper limit of normal&#xD;
  &#xD;
                 -  ALT (SGPT) ≤ 2.5 X institutional upper limit of normal&#xD;
  &#xD;
                 -  Serum Creatinine within normal institutional limits&#xD;
  &#xD;
            -  Subjects must have at least one suitable lymphatic and one suitable vein amenable to&#xD;
               lymphovenous bypass anastomosis.&#xD;
  &#xD;
            -  Subjects must have the ability to understand and the willingness to sign a written&#xD;
               informed consent document.&#xD;
  &#xD;
            -  Patients may be treated with adjuvant or neoadjuvant therapies at the discretion of&#xD;
               the treating medical oncologist&#xD;
  &#xD;
            -  Patients may be treated with adjuvant radiation therapy at the discretion of the&#xD;
               treating radiation oncologist.&#xD;
  &#xD;
            -  Patients may be treated with either mastectomy or breast conserving surgery at the&#xD;
               discretion of the treating surgical oncologist.&#xD;
  &#xD;
            -  In order to complete the Lymph-ICF-UL questionnaire, participants must be able to&#xD;
               speak and/or read English.&#xD;
  &#xD;
            -  Healthy controls include women aged 18-75 without a current or past history of breast&#xD;
               cancer or lymphedema who are willing to undergo blood draw.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Contraindication to ICG as a) iodine hypersensitivity, b) renal failure, c) uremia and&#xD;
               d) on dialysis.&#xD;
  &#xD;
            -  Subjects receiving any prior surgical treatment or radiation to the axilla prior to&#xD;
               protocol enrollment (except sentinel node biopsy within the past 30 days).&#xD;
  &#xD;
            -  Subjects with known regional cervical or supraclavicular nodal disease or distant&#xD;
               metastatic disease.&#xD;
  &#xD;
            -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
               composition to isosulfan blue dye or other agents used in this study.&#xD;
  &#xD;
            -  History of pre-existing lymphedema or measured lymphedema at baseline upon study&#xD;
               enrollment&#xD;
  &#xD;
            -  BMI greater than or equal to 40.&#xD;
  &#xD;
            -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
               infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
               arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
               study requirements&#xD;
  &#xD;
            -  History of pulmonary embolism or deep venous thrombosis&#xD;
  &#xD;
            -  Patients must not be on anticoagulant therapy with warfarin, clopidogrel (Plavix),&#xD;
               apixavan (Eliquis), heparin, low molecular weight heparin, rivaroxaban (Xarelto),&#xD;
               ticlodipine (Ticlid), fonduparinux (Arixtra) with the exception of routine heparin&#xD;
               flushes to a portacath.&#xD;
  &#xD;
            -  Patients treated with sentinel lymph node biopsy only without ALND&#xD;
  &#xD;
            -  Arteriovenous fistula or the presence of an indwelling peripherally inserted central&#xD;
               catheter (PICC line), or the presence of a central venous line or portacath in the&#xD;
               ipsilateral arm.&#xD;
  &#xD;
            -  ECOG performance status of 2 or higher.&#xD;
  &#xD;
            -  Pregnant or breast-feeding women are excluded from the study given that it is unknown&#xD;
               whether isosulfan blue can cause fetal harm and it is desirable to limit anesthesia&#xD;
               time in this population&#xD;
  &#xD;
            -  Less than 18 years of age or greater than 75 years of age.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Julie E Lang, MD, FACS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cleveland Clinic Foundation: Digestive Disease &amp; Surgery Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Julie E Lang, MD, FACS</last_name>
      <phone>216-636-2843</phone>
      <email>LangJ2@ccf.org</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Prophylactic Lymphaticovenous Bypass</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT05970107
  org study id: CASE2123
  nct id: NCT05970107
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Lymphedema is a devastating complication of breast cancer surgery that decreases the quality
        of life of up to 40% of breast cancer survivors. Most lymphedema in breast cancer patients is
        because lymphatics shared between the axilla and the arm are sacrificed during axillary lymph
        node dissection (ALND) surgery, which removes an average of 15 lymph nodes in node positive
        patients. CCF's breast cancer plastic microvascular surgeons and breast surgical oncologists
        have collaborated to refine a surgical technique known as LVB that may be used either as a
        preventive measure (prophylactic LVB) or as a therapeutic intervention (therapeutic LVB).
        Lymphatic reconstruction with LVB may be an improvement to the current standard of care for
        node positive breast cancer patients undergoing ALND.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Rate of lymphedema onset after prophylactic LVB-Objective Criteria
  time frame: At month 4 post treatment
  description: This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline.
  The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.
  measure: Rate of lymphedema onset after prophylactic LVB-Objective Criteria
  time frame: At month 8 post treatment
  description: This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline.
  The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.
  measure: Rate of lymphedema onset after prophylactic LVB-Objective Criteria
  time frame: At month 12 post treatment
  description: This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline.
  The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.
  measure: Rate of lymphedema onset after prophylactic LVB-Objective Criteria
  time frame: At month 16 post treatment
  description: This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline.
  The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.
  measure: Rate of lymphedema onset after prophylactic LVB-Objective Criteria
  time frame: At month 20 post treatment
  description: This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline.
  The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.
  measure: Rate of lymphedema onset after prophylactic LVB-Objective Criteria
  time frame: At month 24 post treatment
  description: This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline.
  The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.
  measure: Rate of lymphedema onset after prophylactic LVB-Objective Criteria
  time frame: At month 27 post treatment
  description: This is defined as a diagnosis of lymphedema by at least three of the four objective measurements performed serially every four months after baseline.
  The four diagnostic measurements to be performed at baseline and then every four months during the study timeframe are: a) Limb measurements; b) 3D Infrared optoelectronic volumetry (Perometer); c) Bioimpedence Spectroscopy (LDEX); d) LymphaTech handheld 3D scan.
  measure: Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
  time frame: At month 4 post treatment
  description: The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.
  measure: Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
  time frame: At month 8 post treatment
  description: The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.
  measure: Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
  time frame: At month 12 post treatment
  description: The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.
  measure: Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
  time frame: At month 16 post treatment
  description: The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.
  measure: Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
  time frame: At month 20 post treatment
  description: The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.
  measure: Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
  time frame: At month 24 post treatment
  description: The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.
  measure: Rate of lymphedema onset after prophylactic LVB-Subjective Criteria
  time frame: At month 27 post treatment
  description: The patient-reported outcomes survey Lymph-ICF-UL will be used to compare subjective symptoms of lymphedema to the four diagnostic measurements to determine which is the most sensitive and evaluate the concordance of these tests.
  arm group label: ALND + LVB
  arm group type: Experimental
  description: The prophylactic LVB cohort will undergo ALND plus ARM and immediate lymphatic reconstruction with lymphaticovenous bypass (LVB). During the ALND, axillary reverse mapping will be used to visualize the lymphatics draining into the axilla, to aid in preserving the draining lymphatic vessels for anastomosis in LVB.
  Radiation therapy will be administered as determined by the treating radiation oncologist.
  arm group label: ALND without LVB
  arm group type: Active Comparator
  description: Patients in the ALND alone cohort will undergo ALND plus ARM
  Radiation therapy will be administered as determined by the treating radiation oncologist.
  intervention type: Procedure
  intervention name: Axillary Lymph Node Dissection
  description: ALND happens after cancer cells are found during a sentinel lymph node biopsy.
  ALND can remove lymph nodes located above, below or directly underneath a muscle that runs along the side of the upper chest.
  arm group label: ALND + LVB
  arm group label: ALND without LVB
  other name: ALND
  intervention type: Procedure
  intervention name: Axillary Reverse Mapping
  description: Axillary reverse mapping (ARM) is a technique where blue dye is injected into the upper arm at surgery, allowing direct visualization of arm lymphatics and nodes during ALND
  arm group label: ALND + LVB
  arm group label: ALND without LVB
  other name: ARM
  intervention type: Procedure
  intervention name: Lymphaticovenous Bypass
  description: Lymphaticovenous bypass/anastomosis (LVB/LVA) involves supramicrosurgery in which the blocked lymphatic vessel of an affected limb is connected to a nearby vein with the aid of ultra-fine instruments and a powerful operating microscope.
  arm group label: ALND + LVB
  other name: LVB
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Julie E Lang, MD, FACS
  role: Principal Investigator
  affiliation: Cleveland Clinic Foundation: Digestive Disease & Surgery Institute
  last name: Julie E Lang, MD, FACS
  phone: 216-636-2843
  email: LangJ2@ccf.org
  responsible party type: Sponsor
  mesh term: Breast Neoplasms