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/NCT05982886</url>
    </required_header>
    <id_info>
      <org_study_id>CBYL719A0US11</org_study_id>
      <nct_id>NCT05982886</nct_id>
    </id_info>
    <brief_title>Biomarker Testing and Treatment Patterns Among Patients With PIK3CA Mutation in Advanced Breast Cancer</brief_title>
    <official_title>Biomarker Testing and Treatment Patterns Among Patients With PIK3CA Mutation in Advanced Breast Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Novartis Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Novartis</source>
    <brief_summary>
      <textblock>
        This was a retrospective observational study of patients with advanced breast cancer (BC).&#xD;
        This non-interventional study was conducted using discrete structured data and medical record&#xD;
        abstraction, if needed, from patients treated at Texas Oncology, the designated research&#xD;
        organization and a community oncology practice. The first date of a new diagnosis of advanced&#xD;
        BC (de novo or progressed to advanced BC) defined the study index date. To allow for an&#xD;
        adequate potential duration of follow-up (retrospectively observed) after the index date over&#xD;
        which PIK3CA testing and treatment patterns was observed, a minimum follow-up opportunity of&#xD;
        6 months after the diagnosis of advanced BC at the time of data pull and/or abstraction was&#xD;
        required.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 15, 2021</start_date>
    <completion_date type="Actual">April 1, 2021</completion_date>
    <primary_completion_date type="Actual">April 1, 2021</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Number of patients with PIK3CA mutations</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Time from first BC diagnosis to first PIK3CA evaluation</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Time from advanced BC diagnosis to first PIK3CA evaluation</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Time from initiation of first-line treatment for advanced BC diagnosis to first PIK3CA evaluation</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of tests for patients with CDK4/6 inhibitor treatment</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Time from progression on CDK4/6 inhibitor to first PIK3CA evaluation</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Year of (first, where applicable) PIK3CA evaluation</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Result of PIK3CA evaluation (negative, positive, unknown)</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Type of biopsy</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Type of tissue sample, for patients who had tissue biopsy</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Source of tissue sample, for patients who had tissue biopsy</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Analytical method used for PIK3CA evaluation</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Age at advanced breast cancer diagnosis</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stage when patients were diagnosed with BC</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with known metastatic sites</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Performance as assessed by Karnofsky Performace Scale</measure>
      <time_frame>Up to approximately 6 years</time_frame>
      <description>The Karnofsky Performance Scale is a measure of functional impairment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Performance as assessed by the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale</measure>
      <time_frame>Up to approximately 6 years</time_frame>
      <description>The ECOG performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Height</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body mass index (BMI)</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients per stage of cancer</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients per line of treatment</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time from advanced diagnosis to initiation of lines of treatment</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients per systemic therapy</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients per treatment sequence</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients per supportive treatment</measure>
      <time_frame>Up to approximately 6 years</time_frame>
    </secondary_outcome>
    <number_of_groups>5</number_of_groups>
    <enrollment type="Actual">1093</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>PIK3CA positive: HR+ Her2-</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>PIK3CA positive: HR- Her2-</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>PIK3CA positive: HR- Her2+</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>PIK3CA positive: HR+ Her2+</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>PIK3CA negative</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          This was a retrospective, noninterventional cohort study&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who met the following criteria were eligible for abstraction:&#xD;
  &#xD;
            -  Newly diagnosed advanced BC between 01 January 2015, and 30 June 2020&#xD;
  &#xD;
            -  Evaluated for a PIK3CA mutation and identified PIK3CA gene status&#xD;
  &#xD;
            -  No evidence of active other malignant neoplasms within 3 years (except nonmelanoma&#xD;
               skin cancer or carcinoma in situ) prior to diagnosis of advanced BC&#xD;
  &#xD;
            -  At least 18 years of age at the time of first diagnosis of BC&#xD;
  &#xD;
            -  Patients may be alive or deceased at the time of abstraction&#xD;
  &#xD;
            -  Not ever enrolled in the following interventional clinical trials evaluating PI3K&#xD;
               inhibitors:&#xD;
  &#xD;
                 -  SOLAR-1 trial (NCT0243731) evaluating alpelisib (BYL719)&#xD;
  &#xD;
                 -  BELLE-2 or BELLE-3 trial (NCT01610284, NCT01633060) evaluating buparlisib&#xD;
                    (BKM120)&#xD;
  &#xD;
                 -  SANDPIPER trial (NCT02340221) evaluating taselisib (GDC-0032)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          None&#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>Novartis Pharmaceuticals</last_name>
      <role>Study Director</role>
      <affiliation>Novartis Pharmaceuticals</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Novartis</name>
        <address>
          <city>East Hanover</city>
          <state>New Jersey</state>
          <zip>07936</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Breast cancer,</keyword>
    <keyword>PIK3CA,</keyword>
    <keyword>Alpelisib,</keyword>
    <keyword>non-interventional study,</keyword>
    <keyword>HR+</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/NCT05982886
  org study id: CBYL719A0US11
  nct id: NCT05982886
  lead sponsor: 
  This was a retrospective observational study of patients with advanced breast cancer (BC).
        This non-interventional study was conducted using discrete structured data and medical record
        abstraction, if needed, from patients treated at Texas Oncology, the designated research
        organization and a community oncology practice. The first date of a new diagnosis of advanced
        BC (de novo or progressed to advanced BC) defined the study index date. To allow for an
        adequate potential duration of follow-up (retrospectively observed) after the index date over
        which PIK3CA testing and treatment patterns was observed, a minimum follow-up opportunity of
        6 months after the diagnosis of advanced BC at the time of data pull and/or abstraction was
        required.
  observational model: Cohort
  time perspective: Retrospective
  measure: Number of patients with PIK3CA mutations
  time frame: Up to approximately 6 years
  measure: Time from first BC diagnosis to first PIK3CA evaluation
  time frame: Up to approximately 6 years
  measure: Time from advanced BC diagnosis to first PIK3CA evaluation
  time frame: Up to approximately 6 years
  measure: Time from initiation of first-line treatment for advanced BC diagnosis to first PIK3CA evaluation
  time frame: Up to approximately 6 years
  measure: Number of tests for patients with CDK4/6 inhibitor treatment
  time frame: Up to approximately 6 years
  measure: Time from progression on CDK4/6 inhibitor to first PIK3CA evaluation
  time frame: Up to approximately 6 years
  measure: Year of (first, where applicable) PIK3CA evaluation
  time frame: Up to approximately 6 years
  measure: Result of PIK3CA evaluation (negative, positive, unknown)
  time frame: Up to approximately 6 years
  measure: Type of biopsy
  time frame: Up to approximately 6 years
  measure: Type of tissue sample, for patients who had tissue biopsy
  time frame: Up to approximately 6 years
  measure: Source of tissue sample, for patients who had tissue biopsy
  time frame: Up to approximately 6 years
  measure: Analytical method used for PIK3CA evaluation
  time frame: Up to approximately 6 years
  measure: Age at advanced breast cancer diagnosis
  time frame: Up to approximately 6 years
  measure: Stage when patients were diagnosed with BC
  time frame: Up to approximately 6 years
  measure: Number of patients with known metastatic sites
  time frame: Up to approximately 6 years
  measure: Performance as assessed by Karnofsky Performace Scale
  time frame: Up to approximately 6 years
  description: The Karnofsky Performance Scale is a measure of functional impairment.
  measure: Performance as assessed by the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
  time frame: Up to approximately 6 years
  description: The ECOG performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.
  measure: Height
  time frame: Up to approximately 6 years
  measure: Weight
  time frame: Up to approximately 6 years
  measure: Body mass index (BMI)
  time frame: Up to approximately 6 years
  measure: Number of patients per stage of cancer
  time frame: Up to approximately 6 years
  measure: Number of patients per line of treatment
  time frame: Up to approximately 6 years
  measure: Time from advanced diagnosis to initiation of lines of treatment
  time frame: Up to approximately 6 years
  measure: Number of patients per systemic therapy
  time frame: Up to approximately 6 years
  measure: Number of patients per treatment sequence
  time frame: Up to approximately 6 years
  measure: Number of patients per supportive treatment
  time frame: Up to approximately 6 years
  arm group label: PIK3CA positive: HR+ Her2-
  arm group label: PIK3CA positive: HR- Her2-
  arm group label: PIK3CA positive: HR- Her2+
  arm group label: PIK3CA positive: HR+ Her2+
  arm group label: PIK3CA negative
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Novartis Pharmaceuticals
  role: Study Director
  affiliation: Novartis Pharmaceuticals
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Breast Neoplasms