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/NCT05966584</url>
    </required_header>
    <id_info>
      <org_study_id>22-276</org_study_id>
      <nct_id>NCT05966584</nct_id>
    </id_info>
    <brief_title>A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer</brief_title>
    <official_title>RETENTION: An Open-Label Phase 2 Trial of InteRlEukin (5) InhibiTion for the prEveNTION of Alpelisib Rash in Metastatic PIK3CA-mutant Hormone-Receptor Positive Breast Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Memorial Sloan Kettering Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>AstraZeneca</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Novartis Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Memorial Sloan Kettering Cancer Center</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</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 researcher are doing this study to find out whether benralizumab is effective at&#xD;
        preventing skin rashes caused by alpelisib in people who have metastatic breast cancer. Skin&#xD;
        rash is a common side effect of alpelisib. Researchers think adding benralizumab to the&#xD;
        standard-of-care hormone treatment and alpelisib may prevent the patient from getting a rash.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 6, 2023</start_date>
    <completion_date type="Anticipated">July 2026</completion_date>
    <primary_completion_date type="Anticipated">July 2026</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>
      <intervention_model_description>A multi-center, open-label, phase 2 trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>proportion of subjects that have a grade ≤1 rash</measure>
      <time_frame>4 weeks</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">63</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Benralizumab and PI3K inhibition (alpelisib)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will receive fulvestrant or AIs and PI3K inhibition (alpelisib) per SOC (fulvestrant on days 1, 15, 29 and monthly thereafter; Ais on a daily continuous basis). Participants will receive one injection of benralizumab 30mg subcutaneously on day -1.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Benralizumab</intervention_name>
      <description>Benralizumab 30mg subcutaneously on day -1.</description>
      <arm_group_label>Benralizumab and PI3K inhibition (alpelisib)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>fulvestrant or AIs) and PI3K inhibition (alpelisib)</intervention_name>
      <description>SOC endocrine therapy (fulvestrant or AIs) and PI3K inhibition (alpelisib)</description>
      <arm_group_label>Benralizumab and PI3K inhibition (alpelisib)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Histologically confirmed metastatic HR-positive, HER2-negative breast cancer. HR&#xD;
               positive is defined by ER status &gt;10% immunohistochemical (IHC) staining of any&#xD;
               intensity.&#xD;
  &#xD;
            2. Must be scheduled to receive SOC endocrine therapy (alpelisib plus fulvestrant or AIs)&#xD;
  &#xD;
            3. Presence of one or more activating PIK3CA mutations in tumor tissue.&#xD;
  &#xD;
            4. Measurable disease per RECIST v1.1 OR at least one predominantly lytic bone lesion&#xD;
               must be present.&#xD;
  &#xD;
            5. Written informed consent provided&#xD;
  &#xD;
            6. Female or male ≥18 years of age&#xD;
  &#xD;
            7. Eastern Cooperative Oncology Group performance status of 0 or 1.&#xD;
  &#xD;
            8. Life expectancy ≥6 months.&#xD;
  &#xD;
            9. Adequate organ and marrow function as defined below:&#xD;
  &#xD;
                 -  Hemoglobin ≥8.0 g/dL (without blood transfusion within 7 days of laboratory test&#xD;
                    used to determine eligibility)&#xD;
  &#xD;
                 -  Absolute neutrophil count ≥1.0 × 10^9 /L (without granulocyte colony stimulating&#xD;
                    factor support within 2 weeks of laboratory test used to determine eligibility)&#xD;
  &#xD;
                 -  Platelet count ≥50 × 10^9 /L (without transfusion within 2 weeks of laboratory&#xD;
                    test used to determine eligibility)&#xD;
  &#xD;
                 -  Total bilirubin (TB) ≤1.0 × institutional upper limit of normal (ULN; Patients&#xD;
                    with known Gilbert's disease who have TB ≤3 × ULN may be enrolled)&#xD;
  &#xD;
                 -  Aspartate transaminase/alanine transaminase ≤2.5 × ULN with normal alkaline&#xD;
                    phosphatase (≤5 × ULN for patients with liver metastases) OR ≤1.5 × ULN in&#xD;
                    conjunction with alkaline phosphatase &gt;2.5 × ULN&#xD;
  &#xD;
                 -  Creatinine ≤1.5 mg/dL&#xD;
  &#xD;
           10. Able to swallow oral medication.&#xD;
  &#xD;
           11. Willing to be randomized to any of the treatment arms and able to comply with the&#xD;
               protocol for the duration of the study including undergoing treatment and scheduled&#xD;
               visits and examinations.&#xD;
  &#xD;
           12. Women must be of postmenopausal status. Postmenopausal status is defined by any one of&#xD;
               the following criteria:&#xD;
  &#xD;
                 -  Prior bilateral oophorectomy&#xD;
  &#xD;
                 -  Age ≥60 years&#xD;
  &#xD;
                 -  Age &lt;60 years and amenorrheic for at least 12 months (spontaneous cessation of&#xD;
                    menses for 12 consecutive months or more in the absence of chemotherapy,&#xD;
                    tamoxifen, toremifene, or ovarian suppression) and follicle-stimulating hormone&#xD;
                    and estradiol levels in the postmenopausal range without an alternative cause.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Known hypersensitivity to alpelisib, fulvestrant or AIs, benralizumab, cetirizine, or&#xD;
               to any of the excipients of alpelisib, fulvestrant or AIs, benralizumab, or&#xD;
               cetirizine.&#xD;
  &#xD;
            2. Concurrent malignancy (basal cell carcinoma of the skin, squamous cell carcinoma of&#xD;
               the skin, or cervical cancer in situ that have undergone curative intent therapy are&#xD;
               allowed)&#xD;
  &#xD;
            3. Individuals with impaired decision making capacity.&#xD;
  &#xD;
            4. Concurrent use of another investigational drug or device for the rash (i.e., outside&#xD;
               of study treatment) during, or within 4 weeks of treatment.&#xD;
  &#xD;
            5. Known use of anti-IL-5 agents or other biologics for the treatment of asthma which are&#xD;
               known to decrease blood eosinophil levels within the past 12 weeks.&#xD;
  &#xD;
            6. Known history of anaphylaxis to benralizumab therapy.&#xD;
  &#xD;
            7. A helminthic parasitic infection diagnosed within 24 weeks prior to the first&#xD;
               treatment, and assent when applicable, was obtained that had not been treated with, or&#xD;
               has failed to respond to, standard of care therapy.&#xD;
  &#xD;
            8. Known history of human immunodeficiency virus (HIV) infection or current chronic or&#xD;
               active hepatitis B or C infection requiring treatment with antiviral therapy.&#xD;
  &#xD;
            9. Active infection that would impair the ability of the patient to receive study&#xD;
               treatment.&#xD;
  &#xD;
           10. Women who are pregnant or breast-feeding.&#xD;
  &#xD;
           11. Any condition which, in the investigator's opinion, makes the subject unsuitable for&#xD;
               trial participation.&#xD;
  &#xD;
           12. Oral corticosteroids at a dose of ≥20mg/day prednisone or equivalent within 14 days&#xD;
               expected to continue during alpelisib therapy.&#xD;
  &#xD;
           13. More than 2 lines of endocrine-based therapy in the metastatic setting.&#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>Mario Lacouture, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mario Lacouture, MD</last_name>
      <phone>646-608-2337</phone>
      <email>lacoutum@mskcc.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Pedram Razavi, MD,PhD</last_name>
      <phone>646-888-4821</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Stanford University</name>
        <address>
          <city>Stanford</city>
          <state>California</state>
          <zip>94305</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Lisa Zaba, MD, PhD</last_name>
        <phone>650-498-6000</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Dana Farber Cancer Institute</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02115</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Nicole LeBoeuf, MD</last_name>
        <phone>617-632-6869</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Basking Ridge (All Protocol Activities)</name>
        <address>
          <city>Basking Ridge</city>
          <state>New Jersey</state>
          <zip>07920</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mario Lacouture, MD</last_name>
        <phone>646-608-2337</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Monmouth (Limited Protocol Activities)</name>
        <address>
          <city>Middletown</city>
          <state>New Jersey</state>
          <zip>07748</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mario Lacouture, MD</last_name>
        <phone>646-608-2337</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)</name>
        <address>
          <city>Commack</city>
          <state>New York</state>
          <zip>11725</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mario Lacouture, MD</last_name>
        <phone>646-608-2337</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Westchester (All Protocol Activities)</name>
        <address>
          <city>Harrison</city>
          <state>New York</state>
          <zip>10604</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mario Lacouture, MD</last_name>
        <phone>646-608-2337</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Cancer Center (All Protocol Activities)</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10065</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mario Lacouture, MD</last_name>
        <phone>646-608-2337</phone>
      </contact>
      <contact_backup>
        <last_name>Pedram Razavi, MD, PhD</last_name>
        <phone>646-888-4821</phone>
      </contact_backup>
      <investigator>
        <last_name>Mario Lacouture, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Rockville (Limited Protocol Activities)</name>
        <address>
          <city>Rockville Centre</city>
          <state>New York</state>
          <zip>11570</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mario Lacouture, MD</last_name>
        <phone>646-608-2337</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memorial Sloan Kettering Nassau (Limited Protocol Activities)</name>
        <address>
          <city>Uniondale</city>
          <state>New York</state>
          <zip>11553</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mario Lacouture, MD</last_name>
        <phone>646-608-2337</phone>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
      <description>Memorial Sloan Kettering Cancer Center</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 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 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Alpelisib</keyword>
    <keyword>Benralizumab</keyword>
    <keyword>Metastatic HR-positive</keyword>
    <keyword>HER2-negative breast cancer</keyword>
    <keyword>Rash</keyword>
    <keyword>22-276</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>Fulvestrant</mesh_term>
      <mesh_term>Benralizumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</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/NCT05966584
  org study id: 22-276
  nct id: NCT05966584
  lead sponsor: 
  collaborator: 
  collaborator: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The researcher are doing this study to find out whether benralizumab is effective at
        preventing skin rashes caused by alpelisib in people who have metastatic breast cancer. Skin
        rash is a common side effect of alpelisib. Researchers think adding benralizumab to the
        standard-of-care hormone treatment and alpelisib may prevent the patient from getting a rash.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: A multi-center, open-label, phase 2 trial
  primary purpose: Treatment
  masking: None (Open Label)
  measure: proportion of subjects that have a grade ≤1 rash
  time frame: 4 weeks
  arm group label: Benralizumab and PI3K inhibition (alpelisib)
  arm group type: Experimental
  description: Patients will receive fulvestrant or AIs and PI3K inhibition (alpelisib) per SOC (fulvestrant on days 1, 15, 29 and monthly thereafter; Ais on a daily continuous basis). Participants will receive one injection of benralizumab 30mg subcutaneously on day -1.
  intervention type: Drug
  intervention name: Benralizumab
  description: Benralizumab 30mg subcutaneously on day -1.
  arm group label: Benralizumab and PI3K inhibition (alpelisib)
  intervention type: Drug
  intervention name: fulvestrant or AIs) and PI3K inhibition (alpelisib)
  description: SOC endocrine therapy (fulvestrant or AIs) and PI3K inhibition (alpelisib)
  arm group label: Benralizumab and PI3K inhibition (alpelisib)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mario Lacouture, MD
  role: Principal Investigator
  affiliation: Memorial Sloan Kettering Cancer Center
  last name: Mario Lacouture, MD
  phone: 646-608-2337
  email: lacoutum@mskcc.org
  last name: Pedram Razavi, MD,PhD
  phone: 646-888-4821
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  url: http://www.mskcc.org/mskcc/html/44.cfm
  description: Memorial Sloan Kettering Cancer Center
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  mesh term: Fulvestrant
  mesh term: Benralizumab
  sharing ipd: Yes
  ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.