<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/NCT04454437</url>
  </required_header>
  <id_info>
    <org_study_id>EVER-132-001</org_study_id>
    <secondary_id>CTR20200914</secondary_id>
    <nct_id>NCT04454437</nct_id>
  </id_info>
  <brief_title>Study of Sacituzumab Govitecan in Chinese Patients With Metastatic Triple-negative Breast Cancer Who Received at Least Two Prior Treatments</brief_title>
  <official_title>A Phase IIb, Single Arm, Multicenter Trial of Sacituzumab Govitecan in Chinese Patients With Metastatic Triple-negative Breast Cancer Who Received at Least Two Prior Treatments</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to learn more about the effectiveness of the study drug,&#xD;
      sacituzumab govitecan-hziy, in Chinese participants with metastatic triple-negative breast&#xD;
      cancer (mTNBC) who received at least 2 systemic chemotherapy regimens.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase IIb, single arm, multicenter study of sacituzumab govitecan-hziy in locally&#xD;
      advanced or metastatic TNBC patients who are refractory or relapsing after at least 2 prior&#xD;
      standard chemotherapy regimens for unresectable, locally advanced or metastatic breast&#xD;
      cancer, and these regimens will qualify regardless of triple-negative status at the time they&#xD;
      were given. The primary endpoint of the trial will be the objective response rate (ORR) per&#xD;
      Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) by Independent Review&#xD;
      Committee (IRC) in all treated patients.&#xD;
&#xD;
      Participants will be treated until progression requiring discontinuation of further&#xD;
      treatment, unacceptable toxicity, study withdrawal, or death, whichever comes first. Tumor&#xD;
      response and progression will be assessed using RECIST v 1.1 and assessment by Investigator&#xD;
      at the trial center will be sufficient for decisions on continuation of treatment. An&#xD;
      independent analysis of response will also be performed by IRC, but this will not be used to&#xD;
      make treatment decisions. All participants will visit the Investigator at regular intervals&#xD;
      for assessment of safety parameters and adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 23, 2020</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">August 6, 2021</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>Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1) By Independent Review Committee (IRC)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) by IRC</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>DOR is defined as the time between the date until the earlier date of disease progression or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Benefit Rate (CBR)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>CBR is defined as best overall response of CR or PR or stable disease (SD) of at least 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>PFS is defined as the time since the first dose of trial treatment until the earlier date of disease progression as defined by RECIST v1.1 or death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>OS is defined as the time since the first dose of trial treatment until death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0</measure>
    <time_frame>First dose date up to 3 years plus 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Experiencing Serious Adverse Events (SAEs) According to NCI CTCAE Version 5.0</measure>
    <time_frame>First dose date up to 3 years plus 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab Govitecan-hziy and Free SN-38</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Cmax is defined as the maximum observed concentration of drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs) Against Sacituzumab Govitecan-hziy</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Metastatic Triple-negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Sacituzumab Govitecan-hziy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive sacituzumab govitecan-hziy 10 mg/kg on Days 1 and 8 of a 21-day cycle. Participants will continue treatment until disease progression or intolerable toxicity or consent withdrawal for any reason.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sacituzumab Govitecan-hziy</intervention_name>
    <description>Administered intravenously</description>
    <arm_group_label>Sacituzumab Govitecan-hziy</arm_group_label>
    <other_name>IMMU-132</other_name>
    <other_name>Trodelvy™</other_name>
    <other_name>GS-0132</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Male or female Chinese, 18 years of age or older providing written informed consent.&#xD;
&#xD;
          2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.&#xD;
&#xD;
          3. Histologically or cytologically confirmed Triple-negative Breast Cancer (TNBC).&#xD;
&#xD;
          4. Refractory to or relapsed after at least 2 prior standard of care chemotherapy&#xD;
             regimens for unresectable, locally advanced or metastatic breast cancer.&#xD;
&#xD;
          5. Measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) in&#xD;
             accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.&#xD;
&#xD;
          6. Availability of archival tumor tissue or newly acquired biopsy (FFPE block or a&#xD;
             minimum of number 10 unstaining tumor slides, recommended from recurrent or metastatic&#xD;
             sites).&#xD;
&#xD;
          7. For individuals with a documented germ-line BRCA1/BRCA2 mutation who received an&#xD;
             approved PARP inhibitor, the PARP inhibitor can be used to meet the criteria for one&#xD;
             of 2 prior standard of care chemotherapies.&#xD;
&#xD;
          8. All individuals must have been previously treated with a taxane regardless of disease&#xD;
             stage (adjuvant, neoadjuvant or advanced) when it was given. Individuals who have&#xD;
             contraindications or are intolerant to taxanes are eligible provided that they&#xD;
             received at least 1 cycle of a taxane and showed contraindications or intolerance&#xD;
             during or at the end of that cycle.&#xD;
&#xD;
          9. Adequate bone marrow, hepatic and renal function, defined as:&#xD;
&#xD;
               -  hemoglobin &gt; 9 g/dL, absolute neutrophil count &gt; 1,500 per mm^3, platelets &gt;&#xD;
                  100,000 per mm^3.&#xD;
&#xD;
               -  creatinine clearance of &gt; 60 ml/min calculated using Cockcroft-Gault equation.&#xD;
&#xD;
               -  bilirubin ≤ 1.5 Upper Limit of Normal (ULN), aspartate amino transferase and&#xD;
                  alanine amino transferase ≤ 2.5 × ULN or ≤ 5 × ULN if known liver metastases and&#xD;
                  serum albumin ≥ 3 g/dL.&#xD;
&#xD;
         10. Recovered from all prior treatment-related toxicities to Grade 1 or less by National&#xD;
             Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE&#xD;
             v 5.0) (except alopecia or peripheral neuropathy that may be Grade 2 or less).&#xD;
&#xD;
         11. Individuals must have completed all prior cancer treatments at least 2 weeks prior to&#xD;
             the first dose including chemotherapy (includes also endocrine treatment),&#xD;
             radiotherapy and major surgery. Prior antibody treatment for cancer must have been&#xD;
             completed at least 3 weeks prior to the first dose.&#xD;
&#xD;
         12. Individuals must have at least a 3-month life expectancy.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Previous treatment with topoisomerase 1 inhibitors as a free form or as other&#xD;
             formulations.&#xD;
&#xD;
          2. Individuals with a history of or current central nervous system (CNS) metastases. A&#xD;
             scan to confirm the absence of brain metastases is not required. Individuals with&#xD;
             unknown CNS metastatic status and any clinical signs indicative of CNS metastases are&#xD;
             eligible if CNS metastases are excluded using CT and/or MRI scans.&#xD;
&#xD;
          3. Individuals with Gilbert's disease.&#xD;
&#xD;
          4. Individuals with non-melanoma skin cancer or carcinoma in situ of the cervix are&#xD;
             eligible, while individuals with other prior malignancies must have had at least a&#xD;
             3-year disease-free interval.&#xD;
&#xD;
          5. Individuals known to be human immunodeficiency virus positive.&#xD;
&#xD;
          6. Individuals with active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.&#xD;
             In individuals with a history of HBV, hepatitis B core antibody (HBcAb) testing is&#xD;
             required and if positive, then HBV DNA testing will be performed and if positive the&#xD;
             individual will be excluded.&#xD;
&#xD;
          7. Known history of unstable angina, myocardial infarction (MI), or chronic heart failure&#xD;
             present within 6 months of first dose or clinically significant cardiac arrhythmia&#xD;
             (other than stable atrial fibrillation) requiring anti-arrhythmia therapy or left&#xD;
             ventricular ejection fraction &lt; 50%.&#xD;
&#xD;
          8. Known history of clinically significant active chronic obstructive pulmonary disease,&#xD;
             or other moderate-to-severe chronic respiratory illness present within 6 months of the&#xD;
             first dose.&#xD;
&#xD;
          9. Infection requiring systematic antibiotic use within 1 week of the first dose.&#xD;
&#xD;
         10. Individuals with active chronic inflammatory bowel disease (ulcerative colitis, Crohn&#xD;
             disease) and individuals with a history of bowel obstruction or gastrointestinal (GI)&#xD;
             perforation.&#xD;
&#xD;
         11. High dose systemic corticosteroids within 2 weeks prior to the first dose (however,&#xD;
             low dose corticosteroids ≤ 10 mg prednisone or equivalent daily are permitted provided&#xD;
             the dose is stable for 4 weeks).&#xD;
&#xD;
         12. Scheduled surgery during the study, other than minor surgery which would not delay&#xD;
             study treatment.&#xD;
&#xD;
         13. Individuals who have received a live vaccine within 30 days of first dose.&#xD;
&#xD;
         14. Rapid deterioration during Screening prior to the first dose, eg, significant change&#xD;
             in performance status, unstable pain symptoms requiring modifications in analgesic&#xD;
             management.&#xD;
&#xD;
         15. Other concurrent medical or psychiatric conditions that, in the Investigator's&#xD;
             opinion, may be likely to confound study interpretation or prevent completion of study&#xD;
             procedures and follow-up examinations.&#xD;
&#xD;
         16. Females who are pregnant or lactating.&#xD;
&#xD;
         17. Females of childbearing potential or fertile males unwilling to use highly effective*&#xD;
             contraception during study and up to 6 months after treatment discontinuation in&#xD;
             females of childbearing potential and 3 months in males post last Investigational&#xD;
             Medicinal Product (IMP) administration.&#xD;
&#xD;
        Note: Other protocol defined Inclusion/Exclusion criteria may apply.&#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>Gilead Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liaoning Cancer Hospital &amp; Institute</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital</name>
      <address>
        <city>Changsha</city>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chongqing University Cancer Hospital</name>
      <address>
        <city>Chongqing</city>
        <zip>404100</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yat-sen University, Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University</name>
      <address>
        <city>Guangzhou</city>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anhui Provincial Hospital</name>
      <address>
        <city>Hefei</city>
        <zip>230001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <zip>230022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute &amp; Hospital</name>
      <address>
        <city>Tianjin</city>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hubei Cancer Hospital</name>
      <address>
        <city>Wuhan</city>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>https://www.gileadclinicaltrials.com/study?nctid=NCT04454437</url>
    <description>Gilead Clinical Trials Website</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sacituzumab govitecan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04454437
org study id: EVER-132-001
secondary id: CTR20200914
nct id: NCT04454437
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The goal of this study is to learn more about the effectiveness of the study drug,
      sacituzumab govitecan-hziy, in Chinese participants with metastatic triple-negative breast
      cancer (mTNBC) who received at least 2 systemic chemotherapy regimens.
This is a Phase IIb, single arm, multicenter study of sacituzumab govitecan-hziy in locally
      advanced or metastatic TNBC patients who are refractory or relapsing after at least 2 prior
      standard chemotherapy regimens for unresectable, locally advanced or metastatic breast
      cancer, and these regimens will qualify regardless of triple-negative status at the time they
      were given. The primary endpoint of the trial will be the objective response rate (ORR) per
      Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) by Independent Review
      Committee (IRC) in all treated patients.

      Participants will be treated until progression requiring discontinuation of further
      treatment, unacceptable toxicity, study withdrawal, or death, whichever comes first. Tumor
      response and progression will be assessed using RECIST v 1.1 and assessment by Investigator
      at the trial center will be sufficient for decisions on continuation of treatment. An
      independent analysis of response will also be performed by IRC, but this will not be used to
      make treatment decisions. All participants will visit the Investigator at regular intervals
      for assessment of safety parameters and adverse events.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1) By Independent Review Committee (IRC)
time frame: Up to 3 years
description: ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).
measure: Duration of Response (DOR) by IRC
time frame: Up to 3 years
description: DOR is defined as the time between the date until the earlier date of disease progression or death.
measure: Clinical Benefit Rate (CBR)
time frame: Up to 3 years
description: CBR is defined as best overall response of CR or PR or stable disease (SD) of at least 6 months.
measure: Progression-free Survival (PFS)
time frame: Up to 3 years
description: PFS is defined as the time since the first dose of trial treatment until the earlier date of disease progression as defined by RECIST v1.1 or death due to any cause.
measure: Overall survival (OS)
time frame: Up to 3 years
description: OS is defined as the time since the first dose of trial treatment until death due to any cause.
measure: Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
time frame: First dose date up to 3 years plus 30 days
measure: Percentage of Participants Experiencing Serious Adverse Events (SAEs) According to NCI CTCAE Version 5.0
time frame: First dose date up to 3 years plus 30 days
measure: Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab Govitecan-hziy and Free SN-38
time frame: Up to 3 years
description: Cmax is defined as the maximum observed concentration of drug.
measure: Percentage of Participants Who Developed Anti-Drug Antibodies (ADAs) Against Sacituzumab Govitecan-hziy
time frame: Up to 3 years
arm group label: Sacituzumab Govitecan-hziy
arm group type: Experimental
description: Participants will receive sacituzumab govitecan-hziy 10 mg/kg on Days 1 and 8 of a 21-day cycle. Participants will continue treatment until disease progression or intolerable toxicity or consent withdrawal for any reason.
intervention type: Drug
intervention name: Sacituzumab Govitecan-hziy
description: Administered intravenously
arm group label: Sacituzumab Govitecan-hziy
other name: IMMU-132
other name: Trodelvy™
other name: GS-0132
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilead Study Director
role: Study Director
affiliation: Gilead Sciences
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
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country: China
url: https://www.gileadclinicaltrials.com/study?nctid=NCT04454437
description: Gilead Clinical Trials Website
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms
mesh term: Sacituzumab govitecan
sharing ipd: No