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/NCT06016387</url>
    </required_header>
    <id_info>
      <org_study_id>4127/CLIMB-LMD</org_study_id>
      <nct_id>NCT06016387</nct_id>
    </id_info>
    <brief_title>Tucatinib With Brain and/or Spinal XRT in Patients With HER2+ Metastatic Breast Cancer and LMD</brief_title>
    <official_title>Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+ Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sunnybrook Health Sciences Centre</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Seagen Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Viatris Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Sunnybrook Health Sciences Centre</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The proposed study will evaluate the safety and efficacy of XRT followed by systemic therapy&#xD;
        among patients with HER2+ metastatic breast cancer and LMD&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Breast cancer is the most common cancer among women worldwide, and the second leading cause&#xD;
        of brain metastases (BrM). Despite recent treatment advances, the prognosis of patients with&#xD;
        breast cancer BrM remains poor, and the prognosis among those with leptomeningeal disease&#xD;
        (LMD) is particularly dire with a median survival of only 2-4 months.&#xD;
  &#xD;
        Patients with HER2+ metastatic breast cancer have a high life-time risk of central nervous&#xD;
        system (CNS) metastases, with an approximately 50% lifetime risk. Although the cause of death&#xD;
        among patients with breast cancer BrM is challenging to ascertain, approximately 50% of&#xD;
        patients with HER2+ BrM are thought to die from central nervous system (CNS) disease&#xD;
        involvement. Among patients with LMD specifically, the cause of death is most commonly&#xD;
        related to CNS disease.&#xD;
  &#xD;
        In an analysis of 430 patients (96 of whom had breast cancer) treated for LMD in the National&#xD;
        Cancer Database between 2005 and 2014, those patients treated with chemotherapy plus&#xD;
        radiotherapy had a longer median overall survival of 5 months (3.5 - 6.5 months) compared to&#xD;
        patients treated with XRT or chemotherapy alone. In addition, a majority (n=18/26, 69%) of&#xD;
        observational studies irrespective of primary tumor site have shown an &quot;improvement or likely&#xD;
        improvement&quot; in survival with the use of XRT for LMD, either alone or in combination with&#xD;
        systemic therapy. Hence, this proposed study will evaluate the safety and efficacy of XRT&#xD;
        followed by systemic therapy (which is considered standard of care) among patients with HER2+&#xD;
        metastatic breast cancer and LMD.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 5, 2023</start_date>
    <completion_date type="Anticipated">October 5, 2028</completion_date>
    <primary_completion_date type="Anticipated">October 5, 2025</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Survival status from the start of XRT • Survival status from the start of XRT</measure>
      <time_frame>From date of baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months</time_frame>
      <description>To assess overall survival (OS) from the start of XRT.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time to CNS progression from the start of XRT</measure>
      <time_frame>From date of baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months</time_frame>
      <description>To determine the time for CNS symptoms progresses from start of XRT in the proposed patient population after completion of brain and/or spinal XRT.&#xD;
  To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety and tolerability (CTCAE v.5.0)</measure>
      <time_frame>From date of baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months</time_frame>
      <description>To determine the safety &amp; tolerability of systemic therapy (tucatinib, trastuzumab and capecitabine) in the proposed patient population after completion of brain and/or spinal XRT.&#xD;
  To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression free survival from the start of XRT</measure>
      <time_frame>From date of baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months</time_frame>
      <description>To determine progression from the start of XRT in the proposed patient population after completion of brain and/or spinal XRT.&#xD;
  To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CNS specific objective response (RANO-BM)</measure>
      <time_frame>Every 6 weeks through study completion, an average of 5 years</time_frame>
      <description>To determine the CNS objective response in the proposed patient population after completion of brain and/or spinal XRT.&#xD;
  To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Extracranial objective response (RECIST v1.1)</measure>
      <time_frame>Every 6 weeks through study completion, an average of 5 years</time_frame>
      <description>To determine the extracranial objective response in the proposed patient population after completion of brain and/or spinal XRT.&#xD;
  To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neurologic-specific QoL (FACT-BR version 4)</measure>
      <time_frame>Pre-treatment, at the start of Cycle 3 (Cycle 3 Day 1, +/- 7 days) and at the Safety Visit</time_frame>
      <description>To determine the neurologic-specific QoL's in the proposed patient population after completion of brain and/or spinal XRT.&#xD;
  To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall QoL (EORTC QLQ-C30 version 3)</measure>
      <time_frame>Pre-treatment, at the start of Cycle 3 (Cycle 3 Day 1, +/- 7 days) and at the Safety Visit</time_frame>
      <description>To determine the Overall QoL in the proposed patient population after completion of brain and/or spinal XRT.&#xD;
  To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>HER2-positive Breast Cancer</condition>
    <condition>LMD</condition>
    <arm_group>
      <arm_group_label>Tucatinib, Transtuzumab, Capecitabine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+ Metastatic Breast Cancer and Leptomeningeal Disease.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tucatinib 150 MG</intervention_name>
      <description>Tucatinib is a potent, selective, adenosine triphosphate-competitive small-molecule inhibitor of the receptor tyrosine kinase HER2. The molecular formula for tubatinib is C26H24N8O2 and it has a molecular weight of 480.52 g/mol.</description>
      <arm_group_label>Tucatinib, Transtuzumab, Capecitabine</arm_group_label>
      <other_name>Tukysa</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Trastuzumab</intervention_name>
      <description>MYL-1401O contains the active substance trastuzumab, which is an IgG1 monoclonal antibody. The molecular size of the intact molecule is around 148 kDa.&#xD;
  Each vial of MYL-1401O contains 150 mg of lyophilized proposed active biosimilar substance trastuzumab as well as 3.36 mg L-Histidine Hydrochloride, 2.16 mg L-Histidine, 115.2 mg sorbitol and 33.6 mg PEG-3350 (Macrogol 3350). Sorbitol and PEG-3350 substitute the α- trehalose dehydrate and polysorbate-20, which are used as excipients in the EU-approved and US-licensed Herceptin formulations.</description>
      <arm_group_label>Tucatinib, Transtuzumab, Capecitabine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Capecitabine</intervention_name>
      <description>Capecitabine is a tumour-activated antineoplastic agent (antimetabolite). The molecular formula for capecitabine is C15H22FN3O6 and has a molecular weight of 359.35 g/mol.</description>
      <arm_group_label>Tucatinib, Transtuzumab, Capecitabine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Brain &amp; Spinal Radiation</intervention_name>
      <description>Brain &amp; Spinal XRT is a treatment for patients with HER2+ metastatic breast cancer and leptomeningeal disease,</description>
      <arm_group_label>Tucatinib, Transtuzumab, Capecitabine</arm_group_label>
      <other_name>Brain &amp; Spinal XRT</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria: Phase 1&#xD;
  &#xD;
            1. Men or women with HER2+ metastatic breast cancer.&#xD;
  &#xD;
            2. Evidence of LMD in the brain and/or spine&#xD;
  &#xD;
            3. Age 18+ at time of consent;&#xD;
  &#xD;
            4. ECOG ≤ 2;&#xD;
  &#xD;
            5. If applicable, the last dose of prior chemotherapy, immunotherapy, endocrine therapy&#xD;
               therapy must have been completed 14 days prior to study enrollment.&#xD;
  &#xD;
            6. More than 14 days or 5 half-lives from the last dose of any experimental agent is&#xD;
               required, whichever is greater;&#xD;
  &#xD;
            7. All toxicity related to prior cancer therapies must have resolved to ≤ Grade 1 prior&#xD;
               to enrollment, except for alopecia; neuropathy, must have resolved to ≤ Grade 2.&#xD;
  &#xD;
          Phase 2: Inclusion Criteria&#xD;
  &#xD;
            1. Left ventricular ejection fraction (LVEF) must be within institutional limits of&#xD;
               normal as assessed by ECHO or MUGA documented within 2 weeks prior to starting&#xD;
               systemic therapy on the study;&#xD;
  &#xD;
            2. Adequate hematologic, liver, and renal function within 2 weeks prior to phase 2&#xD;
               enrollment, as follows:&#xD;
  &#xD;
                 1. Hemoglobin ≥ 9 g/dL&#xD;
  &#xD;
                 2. ANC ≥ 1 x109/L&#xD;
  &#xD;
                 3. Platelets ≥ 100 x109/L&#xD;
  &#xD;
                 4. Total bilirubin ≤ 1.5 X upper limit of normal (ULN)&#xD;
  &#xD;
                 5. AST and ALT ≤ 2.5X ULN&#xD;
  &#xD;
                 6. International normalized ratio (INR) and activated partial thromboplastin time&#xD;
                    (aPTT) ≤ 1.5 X ULN&#xD;
  &#xD;
                 7. Creatinine clearance (CrCL) ≥ 50 mL/min&#xD;
  &#xD;
          Exclusion Criteria: Phase 1&#xD;
  &#xD;
            1. Prior WBRT for brain metastases&#xD;
  &#xD;
            2. Prior therapy specifically directed at LMD&#xD;
  &#xD;
            3. Inability to comply with MRI-based surveillance of CNS disease.&#xD;
  &#xD;
            4. Inability to swallow pills or any significant gastrointestinal diseases such as&#xD;
               inflammatory bowel disease.&#xD;
  &#xD;
            5. Presently known dihydropyrimidine dehydrogenase deficiency;&#xD;
  &#xD;
            6. Diagnosed with Hereditary fructose intolerance;&#xD;
  &#xD;
            7. Diagnosed with Gilbert's disease;&#xD;
  &#xD;
            8. Prior history of other cancer with evidence of disease within the last 5 years;&#xD;
  &#xD;
            9. Prior use of tucatinib at any time prior to enrollment.&#xD;
  &#xD;
          Phase 2:&#xD;
  &#xD;
            1. Currently pregnant or breastfeeding;&#xD;
  &#xD;
            2. Use of a strong cytochrome P450 (CYP)2C8 inhibitor within 5 half-lives of the&#xD;
               inhibitor or use of a strong CYP3A4 or CYP2C8 inducer within 5 days prior to the first&#xD;
               dose of systemic therapy&#xD;
  &#xD;
            3. Myocardial infarction or unstable angina within 6 months prior to the first dose of&#xD;
               systemic therapy.&#xD;
  &#xD;
            4. Blood product transfusions in order to meet eligibility criteria&#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_contact>
      <last_name>CLIMB-LMD Project Manager</last_name>
      <phone>437-247-2617</phone>
      <email>CLIMB-LMD@sunnybrook.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mariam Saleem</last_name>
      <phone>437-243-8968</phone>
      <email>CLIMB-LMD@sunnybrook.ca</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HER2+</keyword>
    <keyword>Breast Cancer</keyword>
    <keyword>Leptomeningeal disease</keyword>
    <keyword>Tucanitib</keyword>
    <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>Capecitabine</mesh_term>
      <mesh_term>Trastuzumab</mesh_term>
      <mesh_term>Tucatinib</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The Aggregate data will be presented and/or published. The IPD will not be available keeping patients privacy in mind.</ipd_description>
    </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/NCT06016387
  org study id: 4127/CLIMB-LMD
  nct id: NCT06016387
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The proposed study will evaluate the safety and efficacy of XRT followed by systemic therapy
        among patients with HER2+ metastatic breast cancer and LMD
  Breast cancer is the most common cancer among women worldwide, and the second leading cause
        of brain metastases (BrM). Despite recent treatment advances, the prognosis of patients with
        breast cancer BrM remains poor, and the prognosis among those with leptomeningeal disease
        (LMD) is particularly dire with a median survival of only 2-4 months.
  
        Patients with HER2+ metastatic breast cancer have a high life-time risk of central nervous
        system (CNS) metastases, with an approximately 50% lifetime risk. Although the cause of death
        among patients with breast cancer BrM is challenging to ascertain, approximately 50% of
        patients with HER2+ BrM are thought to die from central nervous system (CNS) disease
        involvement. Among patients with LMD specifically, the cause of death is most commonly
        related to CNS disease.
  
        In an analysis of 430 patients (96 of whom had breast cancer) treated for LMD in the National
        Cancer Database between 2005 and 2014, those patients treated with chemotherapy plus
        radiotherapy had a longer median overall survival of 5 months (3.5 - 6.5 months) compared to
        patients treated with XRT or chemotherapy alone. In addition, a majority (n=18/26, 69%) of
        observational studies irrespective of primary tumor site have shown an "improvement or likely
        improvement" in survival with the use of XRT for LMD, either alone or in combination with
        systemic therapy. Hence, this proposed study will evaluate the safety and efficacy of XRT
        followed by systemic therapy (which is considered standard of care) among patients with HER2+
        metastatic breast cancer and LMD.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Survival status from the start of XRT • Survival status from the start of XRT
  time frame: From date of baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
  description: To assess overall survival (OS) from the start of XRT.
  measure: Time to CNS progression from the start of XRT
  time frame: From date of baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
  description: To determine the time for CNS symptoms progresses from start of XRT in the proposed patient population after completion of brain and/or spinal XRT.
  To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).
  measure: Safety and tolerability (CTCAE v.5.0)
  time frame: From date of baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
  description: To determine the safety & tolerability of systemic therapy (tucatinib, trastuzumab and capecitabine) in the proposed patient population after completion of brain and/or spinal XRT.
  To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).
  measure: Progression free survival from the start of XRT
  time frame: From date of baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
  description: To determine progression from the start of XRT in the proposed patient population after completion of brain and/or spinal XRT.
  To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).
  measure: CNS specific objective response (RANO-BM)
  time frame: Every 6 weeks through study completion, an average of 5 years
  description: To determine the CNS objective response in the proposed patient population after completion of brain and/or spinal XRT.
  To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).
  measure: Extracranial objective response (RECIST v1.1)
  time frame: Every 6 weeks through study completion, an average of 5 years
  description: To determine the extracranial objective response in the proposed patient population after completion of brain and/or spinal XRT.
  To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).
  measure: Neurologic-specific QoL (FACT-BR version 4)
  time frame: Pre-treatment, at the start of Cycle 3 (Cycle 3 Day 1, +/- 7 days) and at the Safety Visit
  description: To determine the neurologic-specific QoL's in the proposed patient population after completion of brain and/or spinal XRT.
  To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).
  measure: Overall QoL (EORTC QLQ-C30 version 3)
  time frame: Pre-treatment, at the start of Cycle 3 (Cycle 3 Day 1, +/- 7 days) and at the Safety Visit
  description: To determine the Overall QoL in the proposed patient population after completion of brain and/or spinal XRT.
  To determine the efficacy of tucatinib plus trastuzumab and capecitabine for the treatment of patients with HER2+ breast cancer and leptomeningeal metastases (LMD).
  arm group label: Tucatinib, Transtuzumab, Capecitabine
  arm group type: Experimental
  description: Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+ Metastatic Breast Cancer and Leptomeningeal Disease.
  intervention type: Drug
  intervention name: Tucatinib 150 MG
  description: Tucatinib is a potent, selective, adenosine triphosphate-competitive small-molecule inhibitor of the receptor tyrosine kinase HER2. The molecular formula for tubatinib is C26H24N8O2 and it has a molecular weight of 480.52 g/mol.
  arm group label: Tucatinib, Transtuzumab, Capecitabine
  other name: Tukysa
  intervention type: Drug
  intervention name: Trastuzumab
  description: MYL-1401O contains the active substance trastuzumab, which is an IgG1 monoclonal antibody. The molecular size of the intact molecule is around 148 kDa.
  Each vial of MYL-1401O contains 150 mg of lyophilized proposed active biosimilar substance trastuzumab as well as 3.36 mg L-Histidine Hydrochloride, 2.16 mg L-Histidine, 115.2 mg sorbitol and 33.6 mg PEG-3350 (Macrogol 3350). Sorbitol and PEG-3350 substitute the α- trehalose dehydrate and polysorbate-20, which are used as excipients in the EU-approved and US-licensed Herceptin formulations.
  arm group label: Tucatinib, Transtuzumab, Capecitabine
  intervention type: Drug
  intervention name: Capecitabine
  description: Capecitabine is a tumour-activated antineoplastic agent (antimetabolite). The molecular formula for capecitabine is C15H22FN3O6 and has a molecular weight of 359.35 g/mol.
  arm group label: Tucatinib, Transtuzumab, Capecitabine
  intervention type: Radiation
  intervention name: Brain & Spinal Radiation
  description: Brain & Spinal XRT is a treatment for patients with HER2+ metastatic breast cancer and leptomeningeal disease,
  arm group label: Tucatinib, Transtuzumab, Capecitabine
  other name: Brain & Spinal XRT
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: CLIMB-LMD Project Manager
  phone: 437-247-2617
  email: CLIMB-LMD@sunnybrook.ca
  last name: Mariam Saleem
  phone: 437-243-8968
  email: CLIMB-LMD@sunnybrook.ca
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  mesh term: Capecitabine
  mesh term: Trastuzumab
  mesh term: Tucatinib
  sharing ipd: No
  ipd description: The Aggregate data will be presented and/or published. The IPD will not be available keeping patients privacy in mind.