<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/NCT03265379</url>
  </required_header>
  <id_info>
    <org_study_id>17-5560</org_study_id>
    <nct_id>NCT03265379</nct_id>
  </id_info>
  <brief_title>Improving Quality of Life for Patients With Breast Cancer Invading the Chest Wall: A Prospective Registry For Patients Undergoing Full Thickness Chest Wall Resection</brief_title>
  <official_title>Improving Quality of Life for Patients With Breast Cancer Invading the Chest Wall: A Prospective Registry For Patients Undergoing Full Thickness Chest Wall Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</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>
      Although chest wall recurrence of breast cancer is uncommon, it represents a difficult&#xD;
      clinical scenario. The role of full thickness chest wall resection (FTCWR) for breast cancer&#xD;
      recurrence in the chest wall is controversial and is complicated by the fact that no&#xD;
      prospective evidence exists evaluating the utility of FTCWR in prolonging survival or&#xD;
      improving health related quality of life (HRQOL) and thus, there is a lack of evidence to&#xD;
      guide treatment decisions. Gathering HRQOL, local-regional recurrence (LRR) and survival data&#xD;
      in a prospective fashion is thus critical in this population. Therefore, we designed a&#xD;
      prospective trial to evaluate the outcomes for FTCWR in terms of LRC and HRQOL, and&#xD;
      short-term morbidity and mortality, with secondary focus on potential long-term overall&#xD;
      survival benefit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, non-randomized cohort study for patients with chest&#xD;
      wall-recurrent/invasive breast cancer treated with full thickness chest wall resection&#xD;
      (FTCWR), chemotherapy and/or radiation. The design of this study was created using the&#xD;
      framework for surgical trials set out by the IDEAL collaboration (Idea, Development,&#xD;
      Exploration, Assessment, Long-Term follow up), 14 after a systematic evaluation of the&#xD;
      current literature had been completed. Given that no prospective evidence exists in this&#xD;
      patient population and based on the IDEAL framework, this study is designed to create a&#xD;
      prospective registry.&#xD;
&#xD;
      Data on the efficacy of the standard interventions (surgery, chemotherapy, radiation) will be&#xD;
      evaluated using 'global criteria', that is, the data that will be collected via the scores on&#xD;
      the FACT-B, the Brief Pain Inventory, and the specific cancer outcomes as outlined previously&#xD;
      (local regional recurrence (LRC), overall survival, short term morbidity and mortality as&#xD;
      well as disease-free survival).&#xD;
&#xD;
      The primary objective is to measure the differences in Functional Assessment of Cancer&#xD;
      Therapy - Breast (FACT-B) scale scores from baseline to 6 month evaluation.&#xD;
&#xD;
      In addition to measuring health related quality of life (HRQOL) at 6 months, differences in&#xD;
      the FACT-B scale at 1-month, 3-months and 1-year postoperatively will be examined. Rates of&#xD;
      LRC, defined as local recurrence in the ipsilateral chest wall, axilla, infra- or&#xD;
      supraclavicular region at 1, 2, 3 and 5-years postoperatively will be measured, as well as&#xD;
      thirty and ninety-day morbidity and mortality (to be classified using the Thoracic Morbidity&#xD;
      and Mortality (TM and M) classification system). As well, data will be collected on overall&#xD;
      survival, measured as the proportion of patients surviving to at 1-year, 2-years, 3-years and&#xD;
      5 years postoperatively. Lastly, data will be collected on disease-free survival, defined as&#xD;
      any evidence of systemic recurrence plus LRR at 1-year, 2-years, 3-years and 5-years&#xD;
      postoperatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 22, 2017</start_date>
  <completion_date type="Anticipated">August 22, 2030</completion_date>
  <primary_completion_date type="Anticipated">August 22, 2030</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>differences in Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores</measure>
    <time_frame>from baseline to 6 month evaluation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>FACT-B scale</measure>
    <time_frame>1-month, 3-months and 1-year postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local Recurrence</measure>
    <time_frame>1, 2, 3 and 5-years postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity and mortality</measure>
    <time_frame>90 days post op</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>1-year, 2-years, 3-years and 5 years postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Free Survival</measure>
    <time_frame>1-year, 2-years, 3-years and 5 years postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory</measure>
    <time_frame>1 month, 3 months, 6 months and 1 year postoperatively.</time_frame>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">104</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>patients with an isolated recurrence in the chest wall</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>distant metastatic disease is present but who undergo FTCWR</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>patient with primary tumor, no distant ds, failed conventional</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>patients refusing to undergo surgery</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FACT-B and Brief Pain Inventory</intervention_name>
    <description>Quality of Life Questionnaires</description>
    <arm_group_label>distant metastatic disease is present but who undergo FTCWR</arm_group_label>
    <arm_group_label>patient with primary tumor, no distant ds, failed conventional</arm_group_label>
    <arm_group_label>patients refusing to undergo surgery</arm_group_label>
    <arm_group_label>patients with an isolated recurrence in the chest wall</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chest wall-recurrent/invasive breast cancer treated with FTCWR, chemotherapy&#xD;
        and/or radiation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. &gt;18 years of age&#xD;
&#xD;
          2. Breast cancer with invasion of the chest wall (ribs, para-costal soft tissue,&#xD;
             intercostal muscle or soft-tissue) that is:&#xD;
&#xD;
               1. Radiologically proven on cross-sectional imaging&#xD;
&#xD;
               2. Histologically proven&#xD;
&#xD;
          3. Medically fit for surgery&#xD;
&#xD;
          4. &gt;1 year disease-free interval (between initial treatment and recurrence) for patients&#xD;
             with local recurrence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Medically inoperable due to co-morbidity or other contraindication to surgery&#xD;
&#xD;
          2. Technically unresectable disease&#xD;
&#xD;
          3. Ineligible for chemotherapy&#xD;
&#xD;
          4. ECOG performance status &gt;2&#xD;
&#xD;
          5. Patient refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shaf Keshavjee</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jennifer Lister, BSc CCRP</last_name>
    <phone>416-340-4857</phone>
    <email>Jennifer.Lister@uhn.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Health Network (Toronto General Hospital and Princess Margaret Cancer Centre)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Lister, BSc CCRP</last_name>
      <phone>416-340-4857</phone>
      <email>Jennifer.Lister@uhn.ca</email>
    </contact>
    <investigator>
      <last_name>Shaf Keshavjee</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>May 12, 2023</last_update_submitted>
  <last_update_submitted_qc>May 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>


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/NCT03265379
org study id: 17-5560
nct id: NCT03265379
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Although chest wall recurrence of breast cancer is uncommon, it represents a difficult
      clinical scenario. The role of full thickness chest wall resection (FTCWR) for breast cancer
      recurrence in the chest wall is controversial and is complicated by the fact that no
      prospective evidence exists evaluating the utility of FTCWR in prolonging survival or
      improving health related quality of life (HRQOL) and thus, there is a lack of evidence to
      guide treatment decisions. Gathering HRQOL, local-regional recurrence (LRR) and survival data
      in a prospective fashion is thus critical in this population. Therefore, we designed a
      prospective trial to evaluate the outcomes for FTCWR in terms of LRC and HRQOL, and
      short-term morbidity and mortality, with secondary focus on potential long-term overall
      survival benefit.
This study is a prospective, non-randomized cohort study for patients with chest
      wall-recurrent/invasive breast cancer treated with full thickness chest wall resection
      (FTCWR), chemotherapy and/or radiation. The design of this study was created using the
      framework for surgical trials set out by the IDEAL collaboration (Idea, Development,
      Exploration, Assessment, Long-Term follow up), 14 after a systematic evaluation of the
      current literature had been completed. Given that no prospective evidence exists in this
      patient population and based on the IDEAL framework, this study is designed to create a
      prospective registry.

      Data on the efficacy of the standard interventions (surgery, chemotherapy, radiation) will be
      evaluated using 'global criteria', that is, the data that will be collected via the scores on
      the FACT-B, the Brief Pain Inventory, and the specific cancer outcomes as outlined previously
      (local regional recurrence (LRC), overall survival, short term morbidity and mortality as
      well as disease-free survival).

      The primary objective is to measure the differences in Functional Assessment of Cancer
      Therapy - Breast (FACT-B) scale scores from baseline to 6 month evaluation.

      In addition to measuring health related quality of life (HRQOL) at 6 months, differences in
      the FACT-B scale at 1-month, 3-months and 1-year postoperatively will be examined. Rates of
      LRC, defined as local recurrence in the ipsilateral chest wall, axilla, infra- or
      supraclavicular region at 1, 2, 3 and 5-years postoperatively will be measured, as well as
      thirty and ninety-day morbidity and mortality (to be classified using the Thoracic Morbidity
      and Mortality (TM and M) classification system). As well, data will be collected on overall
      survival, measured as the proportion of patients surviving to at 1-year, 2-years, 3-years and
      5 years postoperatively. Lastly, data will be collected on disease-free survival, defined as
      any evidence of systemic recurrence plus LRR at 1-year, 2-years, 3-years and 5-years
      postoperatively.
observational model: Cohort
time perspective: Prospective
measure: differences in Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores
time frame: from baseline to 6 month evaluation
measure: FACT-B scale
time frame: 1-month, 3-months and 1-year postoperatively
measure: Local Recurrence
time frame: 1, 2, 3 and 5-years postoperatively
measure: Morbidity and mortality
time frame: 90 days post op
measure: Overall Survival
time frame: 1-year, 2-years, 3-years and 5 years postoperatively
measure: Disease Free Survival
time frame: 1-year, 2-years, 3-years and 5 years postoperatively
measure: Brief Pain Inventory
time frame: 1 month, 3 months, 6 months and 1 year postoperatively.
arm group label: patients with an isolated recurrence in the chest wall
arm group label: distant metastatic disease is present but who undergo FTCWR
arm group label: patient with primary tumor, no distant ds, failed conventional
arm group label: patients refusing to undergo surgery
intervention type: Other
intervention name: FACT-B and Brief Pain Inventory
description: Quality of Life Questionnaires
arm group label: distant metastatic disease is present but who undergo FTCWR
arm group label: patient with primary tumor, no distant ds, failed conventional
arm group label: patients refusing to undergo surgery
arm group label: patients with an isolated recurrence in the chest wall
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shaf Keshavjee
role: Principal Investigator
affiliation: University Health Network, Toronto
last name: Jennifer Lister, BSc CCRP
phone: 416-340-4857
email: Jennifer.Lister@uhn.ca
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No