<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/NCT01710605</url>
  </required_header>
  <id_info>
    <org_study_id>IC 2011-09</org_study_id>
    <nct_id>NCT01710605</nct_id>
  </id_info>
  <brief_title>Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers</brief_title>
  <official_title>Randomized Trial to Evaluate the Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Curie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Curie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking&#xD;
      into account circulating tumor cells (CTC) to determine the kind of first line treatment for&#xD;
      metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of&#xD;
      treatment will be decided by clinicians, taking into account the criteria usually used in&#xD;
      this setting. In the CTC arm, the type of treatment will be decided by CTC count:&#xD;
      hormone-therapy if &lt;5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main&#xD;
      medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the&#xD;
      progression-free survival: 994 patients are needed, and will be accrued in French cancer&#xD;
      centers. Secondary clinical objectives are to compare toxicity, quality of life and overall&#xD;
      survival between the two arms. The medico-economic study will compare cost per&#xD;
      progression-free life years gained of the two strategies. The financial impact of centralized&#xD;
      (one platform) vs decentralized (several platforms) CTC testing will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</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>Progression free survival evaluation</measure>
    <time_frame>2 years</time_frame>
    <description>According to RECIST 1.1 criteria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Economic evaluation</measure>
    <time_frame>2 years</time_frame>
    <description>Economic impact of the strategy will be evaluated (standard treatment choice vs CTC based treatment choice)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessing patient quality of life</measure>
    <time_frame>2 years</time_frame>
    <description>QLQC30 and BR23 individual questionaries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of treatment safety according to NCI-CTCAEv4.03</measure>
    <time_frame>2 years</time_frame>
    <description>Evaluation of both chemotherapy and hormone therapy will be recorded in CRFs whatever the randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival evaluation</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">800</enrollment>
  <condition>Ductal Infiltrating Metastatic Breast Cancer</condition>
  <condition>Hormone-receptors Positive Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Standard</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment choices (hormonotherapy or chemotherapy) are done according to standard of each center based on clinical, radiological and biological information.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Circulating Tumor Cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment choices (hormonotherapy or chemotherapy) are done according to the number of CTC / 7.5 ml of blood at baseline :&#xD;
If &lt;5 CTC : Hormonotherapy If 5 or more CTC : chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Circulating tumor cells counting at baseline</intervention_name>
    <description>20 ml blood sample collected before randomization</description>
    <arm_group_label>Circulating Tumor Cells</arm_group_label>
    <arm_group_label>Standard</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with metastatic ductal adenocarcinoma breast cancer&#xD;
&#xD;
          -  18 years old or more&#xD;
&#xD;
          -  Hormone receptors positive breast cancer (ER+ and/or PR+) on the last pathological&#xD;
             analysis available.&#xD;
&#xD;
          -  Acceptable patient's clinical situation compatible with chemotherapy or hormonotherapy&#xD;
             administration&#xD;
&#xD;
          -  PS &lt;4&#xD;
&#xD;
          -  Life expectancy &gt; 3 months&#xD;
&#xD;
          -  Evidence of measurable or evaluable disease (RECIST 1.1 criteria)in the 28 days before&#xD;
             selection&#xD;
&#xD;
          -  Information of the patient and signature of the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient treated by chemotherapy or hormonotherapy for their metastatic disease&#xD;
             (treatment failure under adjuvant hormonotherapy are accepted)&#xD;
&#xD;
          -  Her2 positive breast cancer&#xD;
&#xD;
          -  History of other stage II or III cancer in the 5 years. History of other metastatic&#xD;
             cancer (whatever the time between the two cancers).&#xD;
&#xD;
          -  Persons deprived of their freedom or under guardianship.&#xD;
&#xD;
          -  Women unable to comply with the medical follow-up of the study for geographical,&#xD;
             social or mental reasons.&#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>Jean-Yves Pierga</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Curie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre François Baclesse</name>
      <address>
        <city>Caen</city>
        <zip>14076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Georges Francois Leclerc</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Victor Hugo</name>
      <address>
        <city>Le Mans</city>
        <zip>72000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Leon Berard</name>
      <address>
        <city>Lyon</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Paoli Calmettes</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut régional du Cancer de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Azureen de Cancerologie</name>
      <address>
        <city>Mougins</city>
        <zip>06250</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Antoine Lacassagne</name>
      <address>
        <city>Nice</city>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital SAINT-LOUIS</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Europeen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Tenon</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie - Hopital Rene Huguenin</name>
      <address>
        <city>Saint-cloud</city>
        <zip>92210</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancerologie de L'Ouest - Rene Gauducheau</name>
      <address>
        <city>Saint-herblain</city>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Claudius Regaud</name>
      <address>
        <city>Toulouse</city>
        <zip>31052</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Alexis Vautrin</name>
      <address>
        <city>Vandoeuvre Les Nancy</city>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>April 6, 2018</last_update_submitted>
  <last_update_submitted_qc>April 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Circulating tumor cells</keyword>
  <keyword>Breast Cancer</keyword>
  <keyword>Hormone-receptors positive</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Neoplastic Cells, Circulating</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/NCT01710605
org study id: IC 2011-09
nct id: NCT01710605
lead sponsor: 
has dmc: No
The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking
      into account circulating tumor cells (CTC) to determine the kind of first line treatment for
      metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of
      treatment will be decided by clinicians, taking into account the criteria usually used in
      this setting. In the CTC arm, the type of treatment will be decided by CTC count:
      hormone-therapy if <5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main
      medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the
      progression-free survival: 994 patients are needed, and will be accrued in French cancer
      centers. Secondary clinical objectives are to compare toxicity, quality of life and overall
      survival between the two arms. The medico-economic study will compare cost per
      progression-free life years gained of the two strategies. The financial impact of centralized
      (one platform) vs decentralized (several platforms) CTC testing will be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free survival evaluation
time frame: 2 years
description: According to RECIST 1.1 criteria
measure: Economic evaluation
time frame: 2 years
description: Economic impact of the strategy will be evaluated (standard treatment choice vs CTC based treatment choice)
measure: Assessing patient quality of life
time frame: 2 years
description: QLQC30 and BR23 individual questionaries
measure: Evaluation of treatment safety according to NCI-CTCAEv4.03
time frame: 2 years
description: Evaluation of both chemotherapy and hormone therapy will be recorded in CRFs whatever the randomization.
measure: Overall survival evaluation
time frame: 2 years
arm group label: Standard
arm group type: Active Comparator
description: Treatment choices (hormonotherapy or chemotherapy) are done according to standard of each center based on clinical, radiological and biological information.
arm group label: Circulating Tumor Cells
arm group type: Experimental
description: Treatment choices (hormonotherapy or chemotherapy) are done according to the number of CTC / 7.5 ml of blood at baseline :
If <5 CTC : Hormonotherapy If 5 or more CTC : chemotherapy
intervention type: Biological
intervention name: Circulating tumor cells counting at baseline
description: 20 ml blood sample collected before randomization
arm group label: Circulating Tumor Cells
arm group label: Standard
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Yves Pierga
role: Principal Investigator
affiliation: Institut Curie
facility: 
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country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Neoplastic Cells, Circulating