<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/NCT03786575</url>
  </required_header>
  <id_info>
    <org_study_id>NCC1787</org_study_id>
    <nct_id>NCT03786575</nct_id>
  </id_info>
  <brief_title>Clinical Value of Next Generation Sequencing in Endocrine Therapy for Advanced Hormone Receptor Positive/HER-2 Negative Breast Cancer</brief_title>
  <official_title>Clinical Value of Next Generation Sequencing in Endocrine Therapy for Advanced Hormone Receptor Positive/HER-2 Negative Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the landscape of gene mutation before and after endocrine therapy, to search for&#xD;
      molecular markers of endocrine therapy efficacy, and to explore the clinical value of using&#xD;
      NGS detection of ctDNA to guide precise endocrine therapy in patients with advanced breast&#xD;
      cancer. The primary endpoints were progression-free survival (PFS), and the secondary&#xD;
      endpoints included overall survival time (OS), adverse events (AE), and severe adverse events&#xD;
      (SAE).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Before treatment, the patients in the study group underwent NGS detection of ctDNA and&#xD;
      formulated treatment plan according to the test results: 1) those with ESR1 mutation and who&#xD;
      did not use fulvestrant before, preferred fulvestrant; 2) those with abnormal activation of&#xD;
      PI3K/Akt/mTOR pathway signal, preferred mTOR inhibitor combined with endocrine therapy; 3)&#xD;
      those with HER-2 sensitive point mutation, preferred anti-HER-2 therapy combined with&#xD;
      endocrine therapy; 4) PDGFR mutation, preferential use of PDGFR inhibitors combined with&#xD;
      endocrine therapy; 5) no significant gene mutation, making endocrine therapy plan according&#xD;
      to the actual clinical situation. After 2 months of endocrine therapy, all patients underwent&#xD;
      NGS detection of ctDNA, and the efficacy was evaluated according to RECIST v1.1 standard. If&#xD;
      the efficacy evaluation is effective, continue the current treatment and re-evaluate the&#xD;
      efficacy every two months; if the efficacy evaluation is ineffective (progress), then&#xD;
      withdraw from this study. The vital signs, blood routine, liver and kidney functions and&#xD;
      imaging examinations were examined at least every two months in the patients in the study&#xD;
      group, and the curative effect was evaluated according to RECIST v1.1 standard.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2021</primary_completion_date>
  <phase>N/A</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>Progression-free survival (PFS)</measure>
    <time_frame>up to 36 months</time_frame>
    <description>From date of first use endocrine treatment until the date of first documented progression or date of death from any cause, whichever came first</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>up to 60 months</time_frame>
    <description>Time from first use endocrine treatment to death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events (AEs)</measure>
    <time_frame>up to 36 months</time_frame>
    <description>Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Breast Neoplasm Female</condition>
  <condition>Therapeutics</condition>
  <condition>Mutation</condition>
  <arm_group>
    <arm_group_label>NGS detection group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Before treatment, the patients in the study group underwent NGS detection of ctDNA and formulated endocrine treatment plan according to the test results. After 2 months of endocrine therapy, all patients underwent NGS detection of ctDNA, and the efficacy was evaluated according to RECIST v1.1 standard.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Next Generation Sequencing (NGS) detection</intervention_name>
    <description>The NGS detection panel is designed by our team and covers genes that are clinically useful and have definite guiding significance for endocrine therapy</description>
    <arm_group_label>NGS detection group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18 years, female；&#xD;
&#xD;
          2. Pathologically and immunohistochemically confirmed ER-positive/HER-2-negative patients&#xD;
             with advanced breast cancer；&#xD;
&#xD;
          3. According to RECIST standard, lesions can be measured (primary lesion length &gt; 1.0 cm&#xD;
             or lymph node diameter &gt; 1.5 cm)；&#xD;
&#xD;
          4. Previous endocrine therapy resistance, preparation for second-or-above-line endocrine&#xD;
             therapy；&#xD;
&#xD;
          5. No visceral crisis；&#xD;
&#xD;
          6. ECOG PS score: 0-2 points;&#xD;
&#xD;
          7. Laboratory criteria:&#xD;
&#xD;
             ① white blood cells were more than 4 x 109 /L, and neutrophil count (ANC) was more&#xD;
             than 1.5 x 109 /L.&#xD;
&#xD;
             ② platelet (&gt;100 *109/L); hemoglobin (&gt;10g/dL); serum creatinine (&lt;1.5 *normal value)&#xD;
             upper limit (ULN); aspartate aminotransferase (AST) (&lt;2.5 *ULN); alanine&#xD;
             aminotransferase (ALT) (&lt;2.5 *ULN); total bilirubin (&lt;1.5 *ULN); serum creatinine&#xD;
             (&lt;1.5 *ULN);&#xD;
&#xD;
          8. the volunteers voluntarily joined the study, signed informed consent, and had good&#xD;
             compliance and follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or lactation woman&#xD;
&#xD;
          2. With mental disease&#xD;
&#xD;
          3. With severe infection or active gastrointestinal ulcers&#xD;
&#xD;
          4. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or&#xD;
             diabetes&#xD;
&#xD;
          5. taking part or participating in other clinical trials within one month.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Fei Ma, Dr.</last_name>
    <phone>+86-13910217780</phone>
    <email>drmafei@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fei Ma, Dr.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>June 19, 2019</last_update_submitted>
  <last_update_submitted_qc>June 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College</investigator_affiliation>
    <investigator_full_name>Fei Ma</investigator_full_name>
    <investigator_title>Deputy Director of Oncology Medicine</investigator_title>
  </responsible_party>
  <keyword>Breast Neoplasm</keyword>
  <keyword>Next Generation Sequencing</keyword>
  <keyword>Endocrine Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03786575
org study id: NCC1787
nct id: NCT03786575
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
To determine the landscape of gene mutation before and after endocrine therapy, to search for
      molecular markers of endocrine therapy efficacy, and to explore the clinical value of using
      NGS detection of ctDNA to guide precise endocrine therapy in patients with advanced breast
      cancer. The primary endpoints were progression-free survival (PFS), and the secondary
      endpoints included overall survival time (OS), adverse events (AE), and severe adverse events
      (SAE).
Before treatment, the patients in the study group underwent NGS detection of ctDNA and
      formulated treatment plan according to the test results: 1) those with ESR1 mutation and who
      did not use fulvestrant before, preferred fulvestrant; 2) those with abnormal activation of
      PI3K/Akt/mTOR pathway signal, preferred mTOR inhibitor combined with endocrine therapy; 3)
      those with HER-2 sensitive point mutation, preferred anti-HER-2 therapy combined with
      endocrine therapy; 4) PDGFR mutation, preferential use of PDGFR inhibitors combined with
      endocrine therapy; 5) no significant gene mutation, making endocrine therapy plan according
      to the actual clinical situation. After 2 months of endocrine therapy, all patients underwent
      NGS detection of ctDNA, and the efficacy was evaluated according to RECIST v1.1 standard. If
      the efficacy evaluation is effective, continue the current treatment and re-evaluate the
      efficacy every two months; if the efficacy evaluation is ineffective (progress), then
      withdraw from this study. The vital signs, blood routine, liver and kidney functions and
      imaging examinations were examined at least every two months in the patients in the study
      group, and the curative effect was evaluated according to RECIST v1.1 standard.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival (PFS)
time frame: up to 36 months
description: From date of first use endocrine treatment until the date of first documented progression or date of death from any cause, whichever came first
measure: Overall survival (OS)
time frame: up to 60 months
description: Time from first use endocrine treatment to death
measure: Adverse events (AEs)
time frame: up to 36 months
description: Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0)
arm group label: NGS detection group
arm group type: Experimental
description: Before treatment, the patients in the study group underwent NGS detection of ctDNA and formulated endocrine treatment plan according to the test results. After 2 months of endocrine therapy, all patients underwent NGS detection of ctDNA, and the efficacy was evaluated according to RECIST v1.1 standard.
intervention type: Diagnostic Test
intervention name: Next Generation Sequencing (NGS) detection
description: The NGS detection panel is designed by our team and covers genes that are clinically useful and have definite guiding significance for endocrine therapy
arm group label: NGS detection group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fei Ma, Dr.
phone: +86-13910217780
email: drmafei@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College
investigator full name: Fei Ma
investigator title: Deputy Director of Oncology Medicine
mesh term: Breast Neoplasms
sharing ipd: Undecided