<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/NCT03765983</url>
  </required_header>
  <id_info>
    <org_study_id>18-516</org_study_id>
    <nct_id>NCT03765983</nct_id>
  </id_info>
  <brief_title>GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases</brief_title>
  <official_title>Phase II Trial of GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kazia Therapeutics Limited</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Dana-Farber Cancer Institute</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 research study is studying a drug called GDC-0084 as a possible treatment for&#xD;
      HER2-Positive Breast Cancer.&#xD;
&#xD;
      The drugs involved in this study are:&#xD;
&#xD;
        -  GDC-0084&#xD;
&#xD;
        -  Trastuzumab (Herceptin®)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research study is a Phase II clinical trial. Phase II clinical trials test the safety&#xD;
      and effectiveness of an investigational intervention to learn whether the intervention works&#xD;
      in treating a specific disease. &quot;Investigational&quot; means that the intervention is being&#xD;
      studied.&#xD;
&#xD;
      The FDA (the U.S. Food and Drug Administration) has not approved GDC-0084 as a treatment for&#xD;
      any disease.&#xD;
&#xD;
      Trastuzumab is a targeted therapy approved by the FDA to be used alone or in combination with&#xD;
      a chemotherapy drug to treat HER2-positive metastatic breast cancer.&#xD;
&#xD;
      GDC-0084 has been shown to stop the activity of a protein called PI3-kinase. This action&#xD;
      blocks a pathway in the body that cancer cells commonly use to grow and divide.&#xD;
&#xD;
      Trastuzumab is called a &quot;targeted therapy&quot; because it works by attaching itself to specific&#xD;
      receptors on the surface of breast cancer cells, known as HER2 receptors. When targeted&#xD;
      therapies attach to HER2 receptors, the signals that tell the cells to grow are blocked and&#xD;
      the cancer cell may be marked for destruction by the immune system. This process allows&#xD;
      trastuzumab to help slow or stop the growth of the breast cancer.&#xD;
&#xD;
      In this research study, the investigators are looking to see how your cancer responds to the&#xD;
      combination of GDC-0084 and Trastuzumab.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Anticipated">November 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Response Rate in the CNS</measure>
    <time_frame>2 years</time_frame>
    <description>ORR in the CNS according to response assessment in neuro-oncology-brain metastases (RANO-BM) criteria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To evaluate the correlation between inhibition of p-4EBP1 in resected brain tumor tissue and intracranial response in the corresponding patient-derived xenograft (PDX) models of BCBM</measure>
    <time_frame>2 Years</time_frame>
    <description>to correlate on-treatment p4EBP1 levels in the resected brain tumor tissue collected from patients to intracranial response to GDC-0084/trastuzumab and survival in the PDX model generated from the same patient</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CBR</measure>
    <time_frame>18 and 24 weeks</time_frame>
    <description>rate of patients with clinical benefit at 18 and 24 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DOR</measure>
    <time_frame>2 years</time_frame>
    <description>to measure the duration of response in the CNS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective extra-CNS response rates</measure>
    <time_frame>2 years</time_frame>
    <description>the rate of patients who have an objective response outside of the CNS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>2 years</time_frame>
    <description>to evaluate the number of participants with treatment-related adverse events as assessed by CTCAE v4.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>2 years</time_frame>
    <description>measured by RANO-BM and RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>2 years</time_frame>
    <description>to evaluate overall survival</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">47</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Cohort A: single-arm, two stage, phase II cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GDC-0084 45 mg administered orally once daily Trastuzumab administered at a dose of 8 mg/kg intravenously (IV) loading dose; followed by 6 mg/kg IV every 3 weeks thereafter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B: a pre-surgical window cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GDC-0084 45 mg administered orally once daily Trastuzumab administered at a dose of 8 mg/kg intravenously (IV) loading dose; followed by 6 mg/kg IV every 3 weeks thereafter Surgical brain metastasis resection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trastuzumab</intervention_name>
    <description>Trastuzumab is called a &quot;targeted therapy&quot; because it works by attaching itself to specific receptors on the surface of breast cancer cells, known as HER2 receptors. When targeted therapies attach to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the immune system</description>
    <arm_group_label>Cohort A: single-arm, two stage, phase II cohort</arm_group_label>
    <arm_group_label>Cohort B: a pre-surgical window cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GDC-0084</intervention_name>
    <description>GDC-0084 has been shown to stop the activity of a protein called PI3-kinase. This action blocks a pathway in the body that cancer cells commonly use to grow and divide</description>
    <arm_group_label>Cohort A: single-arm, two stage, phase II cohort</arm_group_label>
    <arm_group_label>Cohort B: a pre-surgical window cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Cohort A:&#xD;
&#xD;
          -  At least one measurable CNS metastasis, defined as ≥ 10 mm in at least one dimension.&#xD;
&#xD;
          -  Unequivocal evidence of new and/or progressive brain metastases, and at least one of&#xD;
             the following scenarios:&#xD;
&#xD;
               -  Treated with SRS or surgery with residual un-treated lesions remaining. Such&#xD;
                  participants are eligible for immediate enrollment on this study providing that&#xD;
                  at least one untreated lesion is measurable&#xD;
&#xD;
               -  Participants who have had prior WBRT and/or SRS and then whose lesions have&#xD;
                  subsequently progressed or who have new lesions are also eligible. In this case,&#xD;
                  lesions which have been treated with SRS may be considered as target lesions if&#xD;
                  there is unequivocal evidence, in the opinion of the treating physician, of&#xD;
                  progression following SRS.&#xD;
&#xD;
               -  Participants who have not previously been treated with cranial radiation (e.g.,&#xD;
                  WBRT or SRS) are eligible to enter the study, but such participants must be&#xD;
                  asymptomatic from their CNS metastases and not requiring corticosteroids for&#xD;
                  symptom control.&#xD;
&#xD;
               -  Participants who present with systemic stable/absent or progressive disease are&#xD;
                  eligible to this trial, as long as they fulfill one of the above criteria.&#xD;
&#xD;
        Cohort B:&#xD;
&#xD;
          -  New and/or progressive brain metastasis(es) with clinical indication for resection.&#xD;
&#xD;
          -  All Cohorts:&#xD;
&#xD;
          -  Pathologically confirmed HER2-positive MBC by local laboratory with the following&#xD;
             requirements: HER2 overexpressed or amplified (immunohistochemistry of 3+ or HER2 gene&#xD;
             amplification by in situ hybridization with a ratio of HER2-gene signals to centromere&#xD;
             17 signals ≥ 2.0 or average HER2 copy number ≥ 6.0 signals/cells).&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multigated&#xD;
             acquisition (MUGA) scan.&#xD;
&#xD;
          -  Stable or decreasing corticosteroid dose for at least 7 days prior to initiation of&#xD;
             treatment.&#xD;
&#xD;
          -  Concurrent administration of other anti-cancer therapy during the course of this study&#xD;
             is not allowed. Note that concurrent use of supportive care medications (e.g.&#xD;
             anti-resorptive agents, pain medications) is allowed.&#xD;
&#xD;
          -  The participant is ≥18 years old.&#xD;
&#xD;
          -  Participants must have normal organ and marrow function as defined below:&#xD;
&#xD;
               -  Absolute neutrophil count ≥1,000/μl&#xD;
&#xD;
               -  Platelets ≥75,000/μl&#xD;
&#xD;
               -  Hemoglobin ≥9 g/dL&#xD;
&#xD;
               -  Total bilirubin ≤1.5mg/dL (upper limit of normal) except subject with documented&#xD;
                  Gilbert's syndrome (≤5 x ULN) or liver metastasis, who must have a baseline total&#xD;
                  bilirubin ≤3.0 mg/dL;&#xD;
&#xD;
               -  AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN OR ≤ 5.0 × institutional ULN for&#xD;
                  patients with documented liver metastases.&#xD;
&#xD;
               -  Serum creatinine ≤ 1.5 mg/dL (or glomerular filtration rate ≥ 30 ml/min as&#xD;
                  determined by the Cockcroft-Gault equation)&#xD;
&#xD;
          -  Female subjects of childbearing potential must have a negative serum or urine&#xD;
             pregnancy test within 8 days of initiating protocol therapy.&#xD;
&#xD;
          -  The effects of GDC-0084 on the developing human fetus are unknown and radiotherapy has&#xD;
             known teratogenic effects so women of child-bearing potential and men must agree to&#xD;
             use adequate contraception (barrier method of birth control; abstinence) prior to&#xD;
             study entry and for the duration of study participation and 7 months after completion&#xD;
             of Trastuzumab administration per recommendations from the Trastuzumab package insert.&#xD;
&#xD;
          -  The subject is capable of understanding and complying with the protocol and has signed&#xD;
             the informed consent document.&#xD;
&#xD;
          -  Participant must be able to swallow and retain oral medication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Visceral crisis or impending visceral crisis at time of screening.&#xD;
&#xD;
          -  CNS complications for whom urgent neurosurgical intervention is indicated (e.g.,&#xD;
             resection, shunt placement).&#xD;
&#xD;
          -  Known leptomeningeal metastases [Defined as positive CSF cytology and/or unequivocal&#xD;
             radiological evidence of clinically significant leptomeningeal involvement. CSF&#xD;
             sampling is not required in the absence of suggestive symptoms to exclude&#xD;
             leptomeningeal involvement].&#xD;
&#xD;
          -  Patients with known contraindication to MRI (e.g., due to pacemaker, ferromagnetic&#xD;
             implants, claustrophobia, extreme obesity, hypersensitivity, etc.). However, head CT&#xD;
             with contrast may be used in place of MRI at baseline and throughout the trial if MRI&#xD;
             is contraindicated and a participant's brain metastases are clearly measurable by head&#xD;
             CT.&#xD;
&#xD;
          -  Chemotherapy or targeted therapy within 14 days prior to initiation of protocol&#xD;
             therapy. No washout is required for trastuzumab.&#xD;
&#xD;
          -  Has received prior therapy with a PI3K or mTOR inhibitor.&#xD;
&#xD;
          -  No washout is required for endocrine therapy. If a patient has been on ovarian&#xD;
             suppression for at least 28 days prior to initiation of study treatment, continuation&#xD;
             of ovarian suppression is permitted on protocol. Starting a new endocrine therapy&#xD;
             during protocol therapy is not permitted.&#xD;
&#xD;
          -  Current use or history of receiving a non-approved, investigational treatment within&#xD;
             14 days prior to initiation of protocol therapy.&#xD;
&#xD;
          -  Subjects with a history of hypersensitivity to compounds of similar biologic&#xD;
             composition to GDC-0084 or any constituent of the product.&#xD;
&#xD;
          -  The subject has an uncontrolled intercurrent illness, including, but not limited to,&#xD;
             ongoing or active infection, uncontrolled hypertension, unstable angina pectoris,&#xD;
             uncontrolled cardiac arrhythmia, congestive heart failure-New York Heart Association&#xD;
             Class III or IV, active ischemic heart disease, myocardial infarction within the&#xD;
             previous six months, uncontrolled diabetes mellitus (DM), gastric or duodenal&#xD;
             ulceration diagnosed within the previous 6 months, chronic liver or renal disease, or&#xD;
             severe malnutrition. If a participant has controlled DM but is unable to monitor blood&#xD;
             sugars at home, they will be excluded from the trial.&#xD;
&#xD;
          -  The subject is pregnant or breast-feeding.&#xD;
&#xD;
          -  No active, second potentially life-threatening cancer.&#xD;
&#xD;
          -  Has had major surgery within 21 days before initiation of protocol therapy.&#xD;
&#xD;
          -  Active infection requiring IV antibiotics at the time of protocol therapy initiation.&#xD;
&#xD;
          -  Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs,&#xD;
             resulting in dyspnea at rest.&#xD;
&#xD;
          -  Known intolerance to trastuzumab.&#xD;
&#xD;
          -  QT interval time of ≥ 470 msec.&#xD;
&#xD;
          -  Participants receiving any medications or substances that are strong inhibitors or&#xD;
             strong inducers of CYP3A4 are ineligible. Should a participant be taking one of these&#xD;
             agents and is able to discontinue the therapy or switch to a different agent, no&#xD;
             washout will be required prior to starting study medication. Please see Appendix M for&#xD;
             the list of medications. Corticosteroids, which are weak CYP3A4 inducers are allowed.&#xD;
             Because the lists of these agents are constantly changing, it is important to&#xD;
             regularly consult a frequently-updated list such as&#xD;
             http://medicine.iupui.edu/clinpharm/ddis/table.aspx; medical reference texts such as&#xD;
             the Physicians' Desk Reference may also provide this information. As part of the&#xD;
             enrollment/informed consent procedures, the patient will be counseled on the risk of&#xD;
             interactions with other agents, and what to do if new medications need to be&#xD;
             prescribed or if the patient is considering a new over-the-counter medicine or herbal&#xD;
             product&#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>Jose P Leone, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jose P Leone, MD</last_name>
    <phone>617-632-3800</phone>
    <email>JoseP_Leone@dfci.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jose P Leone, MD</last_name>
      <phone>617-632-3800</phone>
      <email>JoseP_Leone@dfci.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Jose P Leone, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>January 6, 2023</last_update_submitted>
  <last_update_submitted_qc>January 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Jose Pablo Leone</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Brain Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trastuzumab</mesh_term>
    <mesh_term>GDC-0084</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor-Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data can be shared no earlier than one year following the date of publication.</ipd_time_frame>
    <ipd_access_criteria>Requests may be directed to: [contact information for Sponsor-Investigator or designee].</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT03765983
org study id: 18-516
nct id: NCT03765983
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This research study is studying a drug called GDC-0084 as a possible treatment for
      HER2-Positive Breast Cancer.

      The drugs involved in this study are:

        -  GDC-0084

        -  Trastuzumab (Herceptin®)
This research study is a Phase II clinical trial. Phase II clinical trials test the safety
      and effectiveness of an investigational intervention to learn whether the intervention works
      in treating a specific disease. "Investigational" means that the intervention is being
      studied.

      The FDA (the U.S. Food and Drug Administration) has not approved GDC-0084 as a treatment for
      any disease.

      Trastuzumab is a targeted therapy approved by the FDA to be used alone or in combination with
      a chemotherapy drug to treat HER2-positive metastatic breast cancer.

      GDC-0084 has been shown to stop the activity of a protein called PI3-kinase. This action
      blocks a pathway in the body that cancer cells commonly use to grow and divide.

      Trastuzumab is called a "targeted therapy" because it works by attaching itself to specific
      receptors on the surface of breast cancer cells, known as HER2 receptors. When targeted
      therapies attach to HER2 receptors, the signals that tell the cells to grow are blocked and
      the cancer cell may be marked for destruction by the immune system. This process allows
      trastuzumab to help slow or stop the growth of the breast cancer.

      In this research study, the investigators are looking to see how your cancer responds to the
      combination of GDC-0084 and Trastuzumab.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate in the CNS
time frame: 2 years
description: ORR in the CNS according to response assessment in neuro-oncology-brain metastases (RANO-BM) criteria
measure: To evaluate the correlation between inhibition of p-4EBP1 in resected brain tumor tissue and intracranial response in the corresponding patient-derived xenograft (PDX) models of BCBM
time frame: 2 Years
description: to correlate on-treatment p4EBP1 levels in the resected brain tumor tissue collected from patients to intracranial response to GDC-0084/trastuzumab and survival in the PDX model generated from the same patient
measure: CBR
time frame: 18 and 24 weeks
description: rate of patients with clinical benefit at 18 and 24 weeks
measure: DOR
time frame: 2 years
description: to measure the duration of response in the CNS
measure: Objective extra-CNS response rates
time frame: 2 years
description: the rate of patients who have an objective response outside of the CNS
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: 2 years
description: to evaluate the number of participants with treatment-related adverse events as assessed by CTCAE v4.0
measure: Progression Free Survival
time frame: 2 years
description: measured by RANO-BM and RECIST 1.1
measure: Overall Survival
time frame: 2 years
description: to evaluate overall survival
arm group label: Cohort A: single-arm, two stage, phase II cohort
arm group type: Experimental
description: GDC-0084 45 mg administered orally once daily Trastuzumab administered at a dose of 8 mg/kg intravenously (IV) loading dose; followed by 6 mg/kg IV every 3 weeks thereafter
arm group label: Cohort B: a pre-surgical window cohort
arm group type: Experimental
description: GDC-0084 45 mg administered orally once daily Trastuzumab administered at a dose of 8 mg/kg intravenously (IV) loading dose; followed by 6 mg/kg IV every 3 weeks thereafter Surgical brain metastasis resection
intervention type: Drug
intervention name: Trastuzumab
description: Trastuzumab is called a "targeted therapy" because it works by attaching itself to specific receptors on the surface of breast cancer cells, known as HER2 receptors. When targeted therapies attach to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the immune system
arm group label: Cohort A: single-arm, two stage, phase II cohort
arm group label: Cohort B: a pre-surgical window cohort
intervention type: Drug
intervention name: GDC-0084
description: GDC-0084 has been shown to stop the activity of a protein called PI3-kinase. This action blocks a pathway in the body that cancer cells commonly use to grow and divide
arm group label: Cohort A: single-arm, two stage, phase II cohort
arm group label: Cohort B: a pre-surgical window cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jose P Leone, MD
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
last name: Jose P Leone, MD
phone: 617-632-3800
email: JoseP_Leone@dfci.harvard.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Jose Pablo Leone
investigator title: Principal Investigator
mesh term: Breast Neoplasms
mesh term: Brain Neoplasms
mesh term: Trastuzumab
mesh term: GDC-0084
sharing ipd: Yes
ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor-Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data can be shared no earlier than one year following the date of publication.
ipd access criteria: Requests may be directed to: [contact information for Sponsor-Investigator or designee].