<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/NCT02190227</url>
  </required_header>
  <id_info>
    <org_study_id>MJGH-RDA</org_study_id>
    <nct_id>NCT02190227</nct_id>
  </id_info>
  <brief_title>RNA Disruption Assay (RDA) Response Prediction in Neoadjuvant Chemotherapy Breast Cancer Treatment</brief_title>
  <official_title>Tumor RNA Disruption Assay as a Tool to Predict Response to Neoadjuvant Chemotherapy in Breast Cancer: Optimizing Timing of Biopsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jewish General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laurentian University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jewish General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the optimal time to use the Tumor RNA Disruption&#xD;
      Assay (RDA) as a predictor of pathological complete response (pCR) in patients with breast&#xD;
      cancer treated with neoadjuvant chemotherapy.&#xD;
&#xD;
      This is important because the earlier non-responders are identified, the greater is the&#xD;
      impact of reducing side effects of ineffective treatments.&#xD;
&#xD;
      The study hypothesis is that the RDA score will accurately predict for tumor response after&#xD;
      one cycle of chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective clinical trial will determine if the tumor RDA score can predict for pCR&#xD;
      after the first, second, and third cycles of chemotherapy in women with breast cancer treated&#xD;
      with neoadjuvant therapy. Tumor RDA score will also be measured after the first dose of any&#xD;
      new chemotherapy agent if residual palpable disease is present.&#xD;
&#xD;
      Data will be collected until accrual target of 30 patients is met. All patients will undergo&#xD;
      core needle biopsy of the breast tumor and analysis of ER, PR, and HER-2-Neu receptors.&#xD;
      Patients will receive neoadjuvant therapy as recommended by their treating physicians. All&#xD;
      chemotherapy regimens will be acceptable for participation in this study. Usually, these&#xD;
      regimens are between 6 to 8 cycles, often with a switch of chemotherapy regimens after 3 to 4&#xD;
      cycles.&#xD;
&#xD;
      Evaluation of tumor size will be determined by 2 axis tumor measurement performed prior to,&#xD;
      and after each chemotherapy treatment. The Tumor RDA score will be evaluated by performing&#xD;
      fine needle aspiration (FNA) biopsies under local anesthetic, if the tumor is clinically&#xD;
      palpable, after the first, second, and third cycles of chemotherapy. Tumor RDA score will&#xD;
      also be determined if palpable tumor is present after the first cycle of any second&#xD;
      chemotherapy agent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pathologic complete response (pCR).</measure>
    <time_frame>At time of surgery (4-8 months after first dose of neoadjuvant therapy).</time_frame>
    <description>Determine the optimal time at which Tumor RNA Disruption Assay (RDA) can predict pathological complete response (pCR) in patients with breast cancer treated with neoadjuvant chemotherapy.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Invasive Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Tumor RDA biopsy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Tumor RDA score measured from an FNA biopsy after cycle 1-2-3 of neoadjuvant chemotherapy and after first cycle of second chemotherapy agent if palpable tumour present.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tumor RDA biopsy</intervention_name>
    <description>Tumor RDA score measured from an FNA biopsy after cycle 1-2-3 of neoadjuvant chemotherapy and after first cycle of second chemotherapy agent if palpable tumour present.</description>
    <arm_group_label>Tumor RDA biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be female.&#xD;
&#xD;
          -  Patients must be 18 years of age or older.&#xD;
&#xD;
          -  Patients with stage I, II, or III breast cancer that is greater or equal to 2 cm on&#xD;
             clinical examination.&#xD;
&#xD;
          -  Patients that have biopsy proven invasive breast cancer diagnosed by core needle&#xD;
             biopsy&#xD;
&#xD;
          -  Patients who are chemotherapy and radiotherapy naïve for the treatment of the current&#xD;
             breast cancer.&#xD;
&#xD;
          -  Patients that accept to undergo neoadjuvant chemotherapy.&#xD;
&#xD;
          -  Patients with bilateral breast cancer are eligible.&#xD;
&#xD;
          -  Patients that understand, accept, and have signed the approved written consent form.&#xD;
&#xD;
          -  Patients will need to consent to be part of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with one or more of the following conditions are ineligible for this study:&#xD;
&#xD;
          -  Patients who have had previous surgery, chemotherapy or radiotherapy for the current&#xD;
             breast cancer&#xD;
&#xD;
          -  Patients who are pregnant or breast feeding.&#xD;
&#xD;
          -  Psychiatric or addictive disorders or conditions or social factors that may preclude&#xD;
             the patient from meeting study requirements.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Francois Boileau, MD MSc FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University, Montreal, Quebec, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Parissenti AM, Chapman JA, Kahn HJ, Guo B, Han L, O'Brien P, Clemons MP, Jong R, Dent R, Fitzgerald B, Pritchard KI, Shepherd LE, Trudeau ME. Association of low tumor RNA integrity with response to chemotherapy in breast cancer patients. Breast Cancer Res Treat. 2010 Jan;119(2):347-56. doi: 10.1007/s10549-009-0531-x.</citation>
    <PMID>19771508</PMID>
  </reference>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>February 2, 2015</last_update_submitted>
  <last_update_submitted_qc>February 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jewish General Hospital</investigator_affiliation>
    <investigator_full_name>Jean-Fancois Boileau</investigator_full_name>
    <investigator_title>Surgical Oncologist and Clinician-Researcher</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Neoadjuvant</keyword>
  <keyword>RNA Disruption Assay</keyword>
  <keyword>Biopsies</keyword>
  <keyword>Response</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>


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/NCT02190227
org study id: MJGH-RDA
nct id: NCT02190227
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the optimal time to use the Tumor RNA Disruption
      Assay (RDA) as a predictor of pathological complete response (pCR) in patients with breast
      cancer treated with neoadjuvant chemotherapy.

      This is important because the earlier non-responders are identified, the greater is the
      impact of reducing side effects of ineffective treatments.

      The study hypothesis is that the RDA score will accurately predict for tumor response after
      one cycle of chemotherapy.
This prospective clinical trial will determine if the tumor RDA score can predict for pCR
      after the first, second, and third cycles of chemotherapy in women with breast cancer treated
      with neoadjuvant therapy. Tumor RDA score will also be measured after the first dose of any
      new chemotherapy agent if residual palpable disease is present.

      Data will be collected until accrual target of 30 patients is met. All patients will undergo
      core needle biopsy of the breast tumor and analysis of ER, PR, and HER-2-Neu receptors.
      Patients will receive neoadjuvant therapy as recommended by their treating physicians. All
      chemotherapy regimens will be acceptable for participation in this study. Usually, these
      regimens are between 6 to 8 cycles, often with a switch of chemotherapy regimens after 3 to 4
      cycles.

      Evaluation of tumor size will be determined by 2 axis tumor measurement performed prior to,
      and after each chemotherapy treatment. The Tumor RDA score will be evaluated by performing
      fine needle aspiration (FNA) biopsies under local anesthetic, if the tumor is clinically
      palpable, after the first, second, and third cycles of chemotherapy. Tumor RDA score will
      also be determined if palpable tumor is present after the first cycle of any second
      chemotherapy agent.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Pathologic complete response (pCR).
time frame: At time of surgery (4-8 months after first dose of neoadjuvant therapy).
description: Determine the optimal time at which Tumor RNA Disruption Assay (RDA) can predict pathological complete response (pCR) in patients with breast cancer treated with neoadjuvant chemotherapy.
arm group label: Tumor RDA biopsy
arm group type: Other
description: Tumor RDA score measured from an FNA biopsy after cycle 1-2-3 of neoadjuvant chemotherapy and after first cycle of second chemotherapy agent if palpable tumour present.
intervention type: Device
intervention name: Tumor RDA biopsy
description: Tumor RDA score measured from an FNA biopsy after cycle 1-2-3 of neoadjuvant chemotherapy and after first cycle of second chemotherapy agent if palpable tumour present.
arm group label: Tumor RDA biopsy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Francois Boileau, MD MSc FRCSC
role: Principal Investigator
affiliation: McGill University, Montreal, Quebec, Canada
facility: 
country: Canada
citation: Parissenti AM, Chapman JA, Kahn HJ, Guo B, Han L, O'Brien P, Clemons MP, Jong R, Dent R, Fitzgerald B, Pritchard KI, Shepherd LE, Trudeau ME. Association of low tumor RNA integrity with response to chemotherapy in breast cancer patients. Breast Cancer Res Treat. 2010 Jan;119(2):347-56. doi: 10.1007/s10549-009-0531-x.
PMID: 19771508
responsible party type: Principal Investigator
investigator affiliation: Jewish General Hospital
investigator full name: Jean-Fancois Boileau
investigator title: Surgical Oncologist and Clinician-Researcher
mesh term: Breast Neoplasms