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/NCT06016738</url>
    </required_header>
    <id_info>
      <org_study_id>OP-1250-301</org_study_id>
      <secondary_id>OPERA-01</secondary_id>
      <nct_id>NCT06016738</nct_id>
    </id_info>
    <brief_title>OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer</brief_title>
    <acronym>OPERA-01</acronym>
    <official_title>A Phase 3 Randomized, Open-Label Study Of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Olema Pharmaceuticals, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Olema Pharmaceuticals, Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This phase 3 clinical study compares the safety and efficacy of OP-1250 to the standard of&#xD;
        care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer&#xD;
        whose disease has advanced on at least one endocrine therapy in combination with a CDK4/6&#xD;
        inhibitor.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an international, multicenter, randomized, open-label, active-controlled, phase 3&#xD;
        clinical trial comparing the safety and efficacy of OP-1250 as a single agent to standard of&#xD;
        care endocrine therapy of either fulvestrant or an aromatase inhibitor (anastrozole,&#xD;
        letrozole, or exemestane) in adult participants with ER+, HER2- advanced or metastatic breast&#xD;
        cancer whose disease has relapsed or progressed on 1 or 2 prior lines of standard of care&#xD;
        endocrine therapy for metastatic breast cancer. Prior lines of therapy must have included at&#xD;
        least one line of endocrine therapy in combination with a CDK 4/6 inhibitor.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 15, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2026</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 (PFS)</measure>
      <time_frame>From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 2 years)</time_frame>
      <description>To compare PFS, based on a Blinded Independent Review Committee (BIRC) assessment, between arms of OP-1250 and standard of care treatment. This will be assessed separately in populations of ESR1 mutation detected and ESR1 mutation not detected participants.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall Survival (OS)</measure>
      <time_frame>From Date of Randomization until Death Due to Any Cause (estimated as up to 4 years)</time_frame>
      <description>To compare OS between arms of OP-1250 and standard of care treatment. This will be assessed separately in populations of ESR1 mutation detected and ESR1 mutation not detected participants.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">510</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Advanced Breast Cancer</condition>
    <condition>Metastatic Breast Cancer</condition>
    <condition>ER Positive Breast Cancer</condition>
    <condition>HER2 Negative Breast Carcinoma</condition>
    <arm_group>
      <arm_group_label>OP-1250 (palazestrant)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will receive OP-1250</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard of Care Endocrine Therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Subjects will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>OP-1250</intervention_name>
      <description>Patients will be treated with OP-1250 once daily on a 4 week (28 day) cycle</description>
      <arm_group_label>OP-1250 (palazestrant)</arm_group_label>
      <other_name>Palazestrant</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fulvestrant</intervention_name>
      <description>Patients will be treated with fulvestrant on C1D1, C1D15, and C2D1 in the first 4 week (28 day) cycle, and on Day 1 of every subsequent 4 week (28 day) cycle</description>
      <arm_group_label>Standard of Care Endocrine Therapy</arm_group_label>
      <other_name>Faslodex</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Anastrozole</intervention_name>
      <description>Patients will be treated with anastrozole once daily on a 4 week (28 day) cycle</description>
      <arm_group_label>Standard of Care Endocrine Therapy</arm_group_label>
      <other_name>Arimidex</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Letrozole</intervention_name>
      <description>Patients will be treated with letrozole once daily on a 4 week (28 day) cycle</description>
      <arm_group_label>Standard of Care Endocrine Therapy</arm_group_label>
      <other_name>Femara</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Exemestane</intervention_name>
      <description>Patients will be treated with exemestane once daily on a 4 week (28 day) cycle</description>
      <arm_group_label>Standard of Care Endocrine Therapy</arm_group_label>
      <other_name>Aromasin</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key inclusion criteria:&#xD;
  &#xD;
            -  Adult female or male participants.&#xD;
  &#xD;
            -  ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to&#xD;
               curative therapy.&#xD;
  &#xD;
            -  Evaluable disease (measurable disease or bone-only disease).&#xD;
  &#xD;
            -  Previously received a CDK4/6 inhibitor in combination with an endocrine therapy in the&#xD;
               advanced setting. One additional line of ET as a monotherapy will be allowed.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.&#xD;
  &#xD;
            -  Adequate hematologic, hepatic, and renal functions.&#xD;
  &#xD;
            -  Female participants can be pre-, peri- or postmenopausal.&#xD;
  &#xD;
            -  Male and pre- or peri-menopausal female participants must be willing to take a GnRH&#xD;
               (LHRH) agonist.&#xD;
  &#xD;
          Key exclusion criteria:&#xD;
  &#xD;
            -  Symptomatic visceral disease, imminent organ failure, or any disease burden that makes&#xD;
               the participant ineligible for endocrine therapy.&#xD;
  &#xD;
            -  Have received prior chemotherapy in the advanced/metastatic setting.&#xD;
  &#xD;
            -  Have received prior treatment with elacestrant or an investigational estrogen&#xD;
               receptor-directed therapy.&#xD;
  &#xD;
            -  History of allergic reactions to study treatment.&#xD;
  &#xD;
            -  Any contraindications to the selected standard of care endocrine therapy in the local&#xD;
               prescribing information.&#xD;
  &#xD;
            -  Symptomatic central nervous system metastases, carcinomatous meningitis,&#xD;
               leptomeningeal disease, or a spinal cord compression that require immediate treatment.&#xD;
  &#xD;
            -  Clinically significant comorbidities such as significant cardiac or cerebrovascular&#xD;
               disease, gastrointestinal disorders that could affect absorption of study treatment&#xD;
               and others.&#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>Medical Director, MD</last_name>
      <role>Study Director</role>
      <affiliation>Olema Pharmaceuticals, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Olema Pharmaceuticals, Inc.</last_name>
      <phone>415-651-7206</phone>
      <email>OPERA-01@olema.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Letrozole</mesh_term>
      <mesh_term>Fulvestrant</mesh_term>
      <mesh_term>Anastrozole</mesh_term>
      <mesh_term>Exemestane</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06016738
  org study id: OP-1250-301
  secondary id: OPERA-01
  nct id: NCT06016738
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This phase 3 clinical study compares the safety and efficacy of OP-1250 to the standard of
        care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer
        whose disease has advanced on at least one endocrine therapy in combination with a CDK4/6
        inhibitor.
  This is an international, multicenter, randomized, open-label, active-controlled, phase 3
        clinical trial comparing the safety and efficacy of OP-1250 as a single agent to standard of
        care endocrine therapy of either fulvestrant or an aromatase inhibitor (anastrozole,
        letrozole, or exemestane) in adult participants with ER+, HER2- advanced or metastatic breast
        cancer whose disease has relapsed or progressed on 1 or 2 prior lines of standard of care
        endocrine therapy for metastatic breast cancer. Prior lines of therapy must have included at
        least one line of endocrine therapy in combination with a CDK 4/6 inhibitor.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Progression-Free Survival (PFS)
  time frame: From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 2 years)
  description: To compare PFS, based on a Blinded Independent Review Committee (BIRC) assessment, between arms of OP-1250 and standard of care treatment. This will be assessed separately in populations of ESR1 mutation detected and ESR1 mutation not detected participants.
  measure: Overall Survival (OS)
  time frame: From Date of Randomization until Death Due to Any Cause (estimated as up to 4 years)
  description: To compare OS between arms of OP-1250 and standard of care treatment. This will be assessed separately in populations of ESR1 mutation detected and ESR1 mutation not detected participants.
  arm group label: OP-1250 (palazestrant)
  arm group type: Experimental
  description: Subjects will receive OP-1250
  arm group label: Standard of Care Endocrine Therapy
  arm group type: Active Comparator
  description: Subjects will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)
  intervention type: Drug
  intervention name: OP-1250
  description: Patients will be treated with OP-1250 once daily on a 4 week (28 day) cycle
  arm group label: OP-1250 (palazestrant)
  other name: Palazestrant
  intervention type: Drug
  intervention name: Fulvestrant
  description: Patients will be treated with fulvestrant on C1D1, C1D15, and C2D1 in the first 4 week (28 day) cycle, and on Day 1 of every subsequent 4 week (28 day) cycle
  arm group label: Standard of Care Endocrine Therapy
  other name: Faslodex
  intervention type: Drug
  intervention name: Anastrozole
  description: Patients will be treated with anastrozole once daily on a 4 week (28 day) cycle
  arm group label: Standard of Care Endocrine Therapy
  other name: Arimidex
  intervention type: Drug
  intervention name: Letrozole
  description: Patients will be treated with letrozole once daily on a 4 week (28 day) cycle
  arm group label: Standard of Care Endocrine Therapy
  other name: Femara
  intervention type: Drug
  intervention name: Exemestane
  description: Patients will be treated with exemestane once daily on a 4 week (28 day) cycle
  arm group label: Standard of Care Endocrine Therapy
  other name: Aromasin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Medical Director, MD
  role: Study Director
  affiliation: Olema Pharmaceuticals, Inc.
  last name: Olema Pharmaceuticals, Inc.
  phone: 415-651-7206
  email: OPERA-01@olema.com
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  mesh term: Letrozole
  mesh term: Fulvestrant
  mesh term: Anastrozole
  mesh term: Exemestane
  sharing ipd: No