<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/NCT01701050</url>
  </required_header>
  <id_info>
    <org_study_id>COMETI-P2-2012</org_study_id>
    <nct_id>NCT01701050</nct_id>
  </id_info>
  <brief_title>Characterization of Circulating Tumor Cells (CTC) From Patients With Metastatic Breast Cancer Using the CTC-Endocrine Therapy Index</brief_title>
  <acronym>COMETI P2</acronym>
  <official_title>COMETI Phase 2: Characterization of Circulating Tumor Cells (CTC) From Patients With Metastatic Breast Cancer Using the CTC-Endocrine Therapy Index</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Diagnostics, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Diagnostics, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Utilizing CellSearch® technology, the ability to both enumerate and reliably and reproducibly&#xD;
      characterize circulating tumor cells (CTC) for tumor markers that predict endocrine&#xD;
      sensitivity (estrogen receptor [ER] and Bcl-2) and resistance (HER2 and Ki67) has been&#xD;
      demonstrated. An algorithm for a CTC-Endocrine Therapy Index (CTC-ETI) has been constructed&#xD;
      that can be calculated for each patient using the CTC enumeration and marker results. The&#xD;
      primary goal of this study is to determine a CTC-ETI in ER positive, HER2 negative metastatic&#xD;
      breast cancer patients before the initiation of a new endocrine therapy for the&#xD;
      identification of patients that will progress rapidly.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with estrogen receptor (ER) positive metastatic breast cancer (MBC) starting their&#xD;
      first line of endocrine therapy (ET) only have a 30-50% chance of receiving clinical benefit.&#xD;
      For the other 50-70% of patients, ET is ineffective and these patients should probably be&#xD;
      treated with chemotherapy, as is done for ER negative patients. More importantly, in nearly&#xD;
      every clinical trial of ET in ER positive, MBC patients, between 15-30% of enrolled patients&#xD;
      progress in the first 2-3 months, regardless of whether they are receiving first or later&#xD;
      lines of ET. Currently there is no validated method to identify which ER positive MBC&#xD;
      patients will be refractory to ET. Therefore, almost all ER positive patients are treated&#xD;
      with serial endocrine therapies before switching to chemotherapy. The investigators propose&#xD;
      that a subset of these patients would be better served with chemotherapy, in spite of its&#xD;
      increased toxicity profile, rather than delaying chemotherapy during a several month trial of&#xD;
      ineffective, albeit less toxic, ET.&#xD;
&#xD;
      To try and predict benefit from or resistance to ET, an index (the CTC-ETI) has been created&#xD;
      that takes into account the number of CTC (which is prognostic) as well as the phenotype of&#xD;
      the CTC, based on the hypothesis that relative levels of ER and Bcl-2 (high=benefit) and HER2&#xD;
      and Ki67 (high=resistance) are predictive of ET responsiveness or resistance. Although the&#xD;
      preliminary data demonstrate the ability to detect, enumerate, and characterize CTC utilizing&#xD;
      the CellSearch® System, the purpose of the current study is to establish proof of principle&#xD;
      that these 4 markers can be used to generate a CTC-ETI which can be performed at baseline&#xD;
      from patients enrolled at different centers, and that baseline CTC-ETI predicts relative&#xD;
      outcome for patients with ER positive MBC starting a new ET, and can be monitored in such&#xD;
      patients during ET. Successful completion of this study will set the stage for a larger,&#xD;
      definitive study designed to demonstrate the clinical utility of a &quot;refined&quot; CTC-ETI in&#xD;
      patients with ER positive, HER2 negative MBC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2013</start_date>
  <completion_date type="Actual">November 10, 2016</completion_date>
  <primary_completion_date type="Actual">November 10, 2016</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>Rapid Disease Progression</measure>
    <time_frame>Within 3 months after initiation of a new line of enrocrine therapy</time_frame>
    <description>Within 30 days prior to the initiation of therapy, chest &amp; abdomen body imaging (computed tomography [CT], or magnetic resonance imaging [MRI] scanning) plus bone scintigraphic imaging (bone scans or PET scans) or PET-CT scans which encompass both will be performed to identify target and non-target lesions that will be followed with the same imaging techniques 3 months after the initiation of therapy. Objective tumor response will be determined using RECIST v1.1 criteria. Rapid disease progression will be defined as disease progression according to RECIST v1.1 criteria or death due to metastatic breast cancer within 3 months of starting a new ET.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>Up to 12 months after initiation of therapy</time_frame>
    <description>Within 30 days prior to the initiation of of a new line of endocrine therapy (ET), chest &amp; abdomen body imaging (computed tomography [CT], or magnetic resonance imagine [MRI] scanning) plus bone scintigraphic imaging (bone scans or PET scans) or PET-CT scans which encompass both will be performed to identify target and non-target lesions that will be followed with the same imaging techniques 3 months, 6 months, 9 months, and up to 12 months after the initiation of therapy. Objective tumor response will be determined using RECIST v1.1 criteria. Progression Free Survival (PFS) will be measured as the time from the date of starting ET until the date of first documentation of progressive disease according to RECIST v1.1 criteria or death due to any cause. In the absence of these events, PFS will be censored at the date of the last objective disease assessment (up to a maximum of 12 months after the initiation of ET).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Biomarker correlations</measure>
    <time_frame>End of study (up to 12 months after enrollment of final patient)</time_frame>
    <description>Correlate the status of the biomarkers on baseline circulating tumor cells (CTC) with the status of the same biomarkers in primary and/or metastatic tissue collected from the patients.</description>
  </other_outcome>
  <other_outcome>
    <measure>Analytic Validity</measure>
    <time_frame>Baseline blood draw (within 30 days prior to the initiation of therapy)</time_frame>
    <description>Demonstrate that the circulating tumor cell (CTC) endocrine therapy index (CTC-ETI) can be accurately determined at initiation of a new endocrine therapy (baseline) in patients with ER positive, HER2 negative metastatic breast cancer in multiple centers across North America. Baseline blood sample will be evaluated for the following:&#xD;
successful calculation of CTC-ETI;&#xD;
successful enumeration of CTC in the four aliquots;&#xD;
successful determination of CTC Bio-Score for all 4 markers when the average number of cells is ≥5 CTC/7.5mL of blood.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">121</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Blood collection</arm_group_label>
    <description>Female patients 18 years or older with estrogen receptor (ER) positive, HER2 negative, progressive metastatic breast cancer after one or more lines of endocrine therapy (ET) who are initiating a new ET will be enrolled into the study. Patients must have immunohistochemistry (IHC) proven ER positive disease, IHC and/or fluorescence in-situ hybridization (FISH) proven HER2 negative disease, and an ECOG performance status of 0-2. Patients with brain metastases only or those who are progressing on fulvestrant are not eligible for the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood collection</intervention_name>
    <description>Patients will have blood drawn for circulating tumor cell (CTC) endocrine therapy index (CTC-ETI) calculation at baseline (within 30 days prior to the initiation of endocrine therapy) and then subsequently 1, 2, 3 and up 12 months after the initiation of therapy, or at the time of disease progression, whichever occurs first.</description>
    <arm_group_label>Blood collection</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Cartridges containing Circulating Tumor Cells (isolated by CellSearch) as well as primary&#xD;
      and/or metastatic tumor tissue (blocks or slides).&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Female patients 18 years or older with estrogen receptor (ER) positive, HER2 negative,&#xD;
        progressive metastatic breast cancer (MBC) after one or more lines of endocrine therapy&#xD;
        (ET) who are initiating a new ET will be enrolled into the study. Patients must have&#xD;
        immunohistochemistry (IHC) proven ER positive disease, IHC and/or fluorescence in-situ&#xD;
        hybridization (FISH) proven HER2 negative disease, and an ECOG performance status of 0-2.&#xD;
        Patients with brain metastases only or those who are progressing on fulvestrant are not&#xD;
        eligible for the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
          -  Women who are 18 years or older.&#xD;
&#xD;
          -  Patients must have estrogen receptor (ER) positive, HER2 negative metastatic breast&#xD;
             cancer (MBC) with at least one non-irradiated distant site of metastasis.&#xD;
&#xD;
          -  ECOG performance status of 0-2.&#xD;
&#xD;
          -  Patients must have currently progressive metastatic disease according to RECIST v1.1&#xD;
             criteria, AND&#xD;
&#xD;
               -  They have progressed on at least one previous line of endocrine therapy (ET) for&#xD;
                  their metastatic disease (but are not currently progressing on fulvestrant), OR;&#xD;
&#xD;
               -  They show evidence of disease progression during or within 12 months of the end&#xD;
                  of adjuvant ET.&#xD;
&#xD;
          -  Patient is about to start a new line of ET for their metastatic disease&#xD;
&#xD;
          -  Patient is willing and able to undergo standard of care imaging studies (same&#xD;
             imaging/staging modality being used at each evaluation), which are anticipated to be&#xD;
             performed prior to the initiation of therapy and subsequently every 3 months.&#xD;
&#xD;
          -  Patient agrees to the collection and testing of their blood and is willing and able to&#xD;
             provide approximately 40mL blood draw(s) at:&#xD;
&#xD;
               -  Baseline (prior to the initiation of new ET), and;&#xD;
&#xD;
               -  Subsequently at 1, 2, 3 and 12 months after the initiation of therapy, and/or;&#xD;
&#xD;
               -  Time of disease progression.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with local regional recurrence only or brain only metastasis.&#xD;
&#xD;
          -  Patients who are progressing on current fulvestrant therapy (patients who have had&#xD;
             fulvestrant therapy in the past and were subsequently treated with other therapies or&#xD;
             those who are starting fulvestrant as their next line of ET are eligible for the&#xD;
             study).&#xD;
&#xD;
          -  Patients who are or will be taking other unapproved (i.e. not cleared/approved by the&#xD;
             FDA) anti-neoplastic therapies concurrently are not eligible (exception: ET with&#xD;
             everolimus is acceptable).&#xD;
&#xD;
          -  Patients with concomitant malignancies or previous malignancies within the last 5&#xD;
             years, with exception of adequately treated basal or squamous cell carcinoma of the&#xD;
             skin or carcinoma in situ of the cervix.&#xD;
&#xD;
          -  Unable to provide informed consent or high risk that patient may not comply with&#xD;
             protocol requirements (i.e. due to health and/or participation in other research&#xD;
             studies).&#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>Daniel F Hayes, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan Rogel Cancer Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Costanza Paoletti, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan Rogel Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona Oncology Associates</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists</name>
      <address>
        <city>Ft. Myers</city>
        <state>Florida</state>
        <zip>33905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists</name>
      <address>
        <city>St. Petersburg</city>
        <state>Florida</state>
        <zip>33705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Faber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Comprehensive Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Cancer Specialists</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Oncology Hematology</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>12206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Waverly Hematology Oncology</name>
      <address>
        <city>Cary</city>
        <state>North Carolina</state>
        <zip>27518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Cancer Specialists</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abramson Cancer Center, University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Baylor</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mt. Sinai Hosp., Marvette Koffler Breast Center</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Paoletti C, Connelly MC, Chianese D, et al. Multi-parameter molecular characterization of circulating tumor cells (CTC): Development of a CTC-Endocrine Therapy Index (CTC-ETI). Proc Am Assoc Cancer Res, Abstract 4154, 2011.</citation>
  </reference>
  <reference>
    <citation>Paoletti C, Connelly M, Chianese D, et al. Development of Circulating Tumor Cell-Endocrine Therapy Index in Metastaic Breast Cancer Patients. Cancer Research 71(24 Suppl):451 (Abs. P4-07-16), 2011.</citation>
  </reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>March 7, 2017</last_update_submitted>
  <last_update_submitted_qc>March 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>circulating tumor cells</keyword>
  <keyword>CTC</keyword>
  <keyword>metastatic breast cancer</keyword>
  <keyword>endocrine therapy</keyword>
  <keyword>hormone therapy</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/NCT01701050
org study id: COMETI-P2-2012
nct id: NCT01701050
lead sponsor: 
has dmc: No
Utilizing CellSearch® technology, the ability to both enumerate and reliably and reproducibly
      characterize circulating tumor cells (CTC) for tumor markers that predict endocrine
      sensitivity (estrogen receptor [ER] and Bcl-2) and resistance (HER2 and Ki67) has been
      demonstrated. An algorithm for a CTC-Endocrine Therapy Index (CTC-ETI) has been constructed
      that can be calculated for each patient using the CTC enumeration and marker results. The
      primary goal of this study is to determine a CTC-ETI in ER positive, HER2 negative metastatic
      breast cancer patients before the initiation of a new endocrine therapy for the
      identification of patients that will progress rapidly.
Patients with estrogen receptor (ER) positive metastatic breast cancer (MBC) starting their
      first line of endocrine therapy (ET) only have a 30-50% chance of receiving clinical benefit.
      For the other 50-70% of patients, ET is ineffective and these patients should probably be
      treated with chemotherapy, as is done for ER negative patients. More importantly, in nearly
      every clinical trial of ET in ER positive, MBC patients, between 15-30% of enrolled patients
      progress in the first 2-3 months, regardless of whether they are receiving first or later
      lines of ET. Currently there is no validated method to identify which ER positive MBC
      patients will be refractory to ET. Therefore, almost all ER positive patients are treated
      with serial endocrine therapies before switching to chemotherapy. The investigators propose
      that a subset of these patients would be better served with chemotherapy, in spite of its
      increased toxicity profile, rather than delaying chemotherapy during a several month trial of
      ineffective, albeit less toxic, ET.

      To try and predict benefit from or resistance to ET, an index (the CTC-ETI) has been created
      that takes into account the number of CTC (which is prognostic) as well as the phenotype of
      the CTC, based on the hypothesis that relative levels of ER and Bcl-2 (high=benefit) and HER2
      and Ki67 (high=resistance) are predictive of ET responsiveness or resistance. Although the
      preliminary data demonstrate the ability to detect, enumerate, and characterize CTC utilizing
      the CellSearch® System, the purpose of the current study is to establish proof of principle
      that these 4 markers can be used to generate a CTC-ETI which can be performed at baseline
      from patients enrolled at different centers, and that baseline CTC-ETI predicts relative
      outcome for patients with ER positive MBC starting a new ET, and can be monitored in such
      patients during ET. Successful completion of this study will set the stage for a larger,
      definitive study designed to demonstrate the clinical utility of a "refined" CTC-ETI in
      patients with ER positive, HER2 negative MBC.
observational model: Cohort
time perspective: Prospective
measure: Rapid Disease Progression
time frame: Within 3 months after initiation of a new line of enrocrine therapy
description: Within 30 days prior to the initiation of therapy, chest & abdomen body imaging (computed tomography [CT], or magnetic resonance imaging [MRI] scanning) plus bone scintigraphic imaging (bone scans or PET scans) or PET-CT scans which encompass both will be performed to identify target and non-target lesions that will be followed with the same imaging techniques 3 months after the initiation of therapy. Objective tumor response will be determined using RECIST v1.1 criteria. Rapid disease progression will be defined as disease progression according to RECIST v1.1 criteria or death due to metastatic breast cancer within 3 months of starting a new ET.
measure: Progression Free Survival (PFS)
time frame: Up to 12 months after initiation of therapy
description: Within 30 days prior to the initiation of of a new line of endocrine therapy (ET), chest & abdomen body imaging (computed tomography [CT], or magnetic resonance imagine [MRI] scanning) plus bone scintigraphic imaging (bone scans or PET scans) or PET-CT scans which encompass both will be performed to identify target and non-target lesions that will be followed with the same imaging techniques 3 months, 6 months, 9 months, and up to 12 months after the initiation of therapy. Objective tumor response will be determined using RECIST v1.1 criteria. Progression Free Survival (PFS) will be measured as the time from the date of starting ET until the date of first documentation of progressive disease according to RECIST v1.1 criteria or death due to any cause. In the absence of these events, PFS will be censored at the date of the last objective disease assessment (up to a maximum of 12 months after the initiation of ET).
measure: Biomarker correlations
time frame: End of study (up to 12 months after enrollment of final patient)
description: Correlate the status of the biomarkers on baseline circulating tumor cells (CTC) with the status of the same biomarkers in primary and/or metastatic tissue collected from the patients.
measure: Analytic Validity
time frame: Baseline blood draw (within 30 days prior to the initiation of therapy)
description: Demonstrate that the circulating tumor cell (CTC) endocrine therapy index (CTC-ETI) can be accurately determined at initiation of a new endocrine therapy (baseline) in patients with ER positive, HER2 negative metastatic breast cancer in multiple centers across North America. Baseline blood sample will be evaluated for the following:
successful calculation of CTC-ETI;
successful enumeration of CTC in the four aliquots;
successful determination of CTC Bio-Score for all 4 markers when the average number of cells is ≥5 CTC/7.5mL of blood.
arm group label: Blood collection
description: Female patients 18 years or older with estrogen receptor (ER) positive, HER2 negative, progressive metastatic breast cancer after one or more lines of endocrine therapy (ET) who are initiating a new ET will be enrolled into the study. Patients must have immunohistochemistry (IHC) proven ER positive disease, IHC and/or fluorescence in-situ hybridization (FISH) proven HER2 negative disease, and an ECOG performance status of 0-2. Patients with brain metastases only or those who are progressing on fulvestrant are not eligible for the study.
intervention type: Other
intervention name: Blood collection
description: Patients will have blood drawn for circulating tumor cell (CTC) endocrine therapy index (CTC-ETI) calculation at baseline (within 30 days prior to the initiation of endocrine therapy) and then subsequently 1, 2, 3 and up 12 months after the initiation of therapy, or at the time of disease progression, whichever occurs first.
arm group label: Blood collection
Cartridges containing Circulating Tumor Cells (isolated by CellSearch) as well as primary
      and/or metastatic tumor tissue (blocks or slides).
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel F Hayes, M.D.
role: Principal Investigator
affiliation: University of Michigan Rogel Cancer Center
last name: Costanza Paoletti, M.D.
role: Principal Investigator
affiliation: University of Michigan Rogel Cancer Center
facility: 
facility: 
facility: 
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country: Canada
country: United States
citation: Paoletti C, Connelly MC, Chianese D, et al. Multi-parameter molecular characterization of circulating tumor cells (CTC): Development of a CTC-Endocrine Therapy Index (CTC-ETI). Proc Am Assoc Cancer Res, Abstract 4154, 2011.
citation: Paoletti C, Connelly M, Chianese D, et al. Development of Circulating Tumor Cell-Endocrine Therapy Index in Metastaic Breast Cancer Patients. Cancer Research 71(24 Suppl):451 (Abs. P4-07-16), 2011.
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Neoplastic Cells, Circulating