<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/NCT04465097</url>
  </required_header>
  <id_info>
    <org_study_id>20200628GD</org_study_id>
    <nct_id>NCT04465097</nct_id>
  </id_info>
  <brief_title>Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer</brief_title>
  <acronym>NeoTEE</acronym>
  <official_title>Neoadjuvant Tucidinostat and Exemestane in Estrogen Receptor-Positive Early Breast Cancer （NeoTEE）</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital, Sun Yat-Sen University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate the efficacy of tucidinostat combined with exemestane as&#xD;
      neoadjuvant strategy in estrogen receptor-positive early breast cancer patients and explore&#xD;
      the genetic model which can predict neoadjuvant endocrine therapeutic results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is to evaluate the efficacy of tucidinostat combined with exemestane as&#xD;
      neoadjuvant strategy in estrogen receptor-positive early breast cancer patients.This study&#xD;
      will recruit 30 patients. The 30 patients will receive 25 mg exemestane QD for 26 weeks.&#xD;
      Tucidinostat will be prescribed 30 mg BIW from week 3 to week 26. During neoadjuvant&#xD;
      treatment biopsy, CEUS and MRI will be perfomed according to protocol to evaluate the&#xD;
      therapeutic results. Genetic testing will also be performed before and after neoadjuvant&#xD;
      treatment to explore the predictive value. MRI evaluated ORR is primary end point. CEUS&#xD;
      evaluated ORR, pCR, AE and RCB are secondary end point.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 31, 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) evaluated by MRI</measure>
    <time_frame>Up to 31 weeks</time_frame>
    <description>ORR is defined as percentage of participants with Complete Response and Partial Response, assessed by the investigators using MRI according to the Response Evaluation Criteria in Solid Tumors (RECIST)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>objective response rate (ORR) evaluated by CEUS</measure>
    <time_frame>Up to 31 weeks</time_frame>
    <description>Contrast-enhanced ultrasound will also be performed to assess ORR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pathologic complete response rate (pCR)</measure>
    <time_frame>Up to 31 weeks</time_frame>
    <description>The percentage of participants with pathologically assessed ypT0 and ypTis of breast disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effect (AE)</measure>
    <time_frame>Up to 31 weeks</time_frame>
    <description>All advese effect events related with Tucidinostat and Exemestane.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual Cancer Burden (RCB)</measure>
    <time_frame>Up to 31 weeks</time_frame>
    <description>Pathologilly assessed residual cancer burden according to MD Anderson protocol.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Tucidinostat and Exemestane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive exemestane from week 1 to week 26 and Tucidinostat BIW from week 3 to week 26. Courses continue in the absence of disease progression or unacceptable toxicity. If the patient is premenopausal, leuprorelin or goserelin will be prescribed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tucidinostat</intervention_name>
    <description>Tucidinostat: 30 mg BIW (Monday and Thursday) from week 3 to week 26</description>
    <arm_group_label>Tucidinostat and Exemestane</arm_group_label>
    <other_name>Chidamide</other_name>
    <other_name>Epidaza</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exemestane</intervention_name>
    <description>Exemestane: 25 mg QD from week 1 to week 26.</description>
    <arm_group_label>Tucidinostat and Exemestane</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ovarian function suppression</intervention_name>
    <description>If the patient is premenopausal, leuprorelin 3.75mg or goserelin 3.6 mg will be injected every 28 days.</description>
    <arm_group_label>Tucidinostat and Exemestane</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent must be signed；&#xD;
&#xD;
          2. Eastern Cooperative Oncology Group Performance Status: 0~1;&#xD;
&#xD;
          3. Histological confirmation of estrogen receptor (ER) positive and HER 2 negative&#xD;
             invasive breast cancer;&#xD;
&#xD;
          4. Age ≥18 years old；&#xD;
&#xD;
          5. No distant metastatic disease；&#xD;
&#xD;
          6. The disease condition is stage II or stage III;&#xD;
&#xD;
          7. Laboratory exam criteria for enrollment: HGB≥10g/dl, WBC≥4,000/mm3, PLT≥100,000/mm3,&#xD;
             GOT, GPT, ALP≤2 times ULN, TBIL, CCr≤1.5 times ULN.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who are pregnant or lactating at the time of randomization or refuse to&#xD;
             contraception.&#xD;
&#xD;
          2. Patients who received organ transplantation (include bone marrow autologous&#xD;
             transplantation and stem cell transplantation).&#xD;
&#xD;
          3. Patients who have other malignant diseases within 5 years, except for cured skin basal&#xD;
             cell carcinoma, flat cell carcinoma or cervical carcinoma in situ&#xD;
&#xD;
          4. Patients with psychiatric disorder, peripheral or central nerve system disease or any&#xD;
             disorder, which compromises ability to give informed consent or participate in this&#xD;
             study.&#xD;
&#xD;
          5. Patients with sever hepatic, renal,cardiovascular, respiratory, digestive diseases or&#xD;
             uncontrolled diabetes.&#xD;
&#xD;
          6. Patients who had myocardial infarction in the past 12 months.&#xD;
&#xD;
          7. Patients who participate in other clinical trail.&#xD;
&#xD;
          8. Patients who allergy to goserelin, leuprorelin, tucidinostat or aromatase inhibitor.&#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_official>
    <last_name>Ying Lin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital, Sun Yat-Sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ying Lin, MD</last_name>
    <phone>+8602087755766</phone>
    <phone_ext>8212</phone_ext>
    <email>frostlin@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhen Shan, MD</last_name>
    <phone>+86018565396593</phone>
    <email>szsysu@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The first affiliated hospital of Sun Yat-Sen university</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ying Lin, MD</last_name>
      <phone>+860208755766</phone>
      <phone_ext>8212</phone_ext>
      <email>frostlin@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Zhen Shan, MD</last_name>
      <phone>+8602087755766</phone>
      <phone_ext>8212</phone_ext>
      <email>szsysu@126.com</email>
    </contact_backup>
    <investigator>
      <last_name>Ying Lin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Zhen Shan, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Jiang Z, Li W, Hu X, Zhang Q, Sun T, Cui S, Wang S, Ouyang Q, Yin Y, Geng C, Tong Z, Cheng Y, Pan Y, Sun Y, Wang H, Ouyang T, Gu K, Feng J, Wang X, Wang S, Liu T, Gao J, Cristofanilli M, Ning Z, Lu X. Tucidinostat plus exemestane for postmenopausal patients with advanced, hormone receptor-positive breast cancer (ACE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Jun;20(6):806-815. doi: 10.1016/S1470-2045(19)30164-0. Epub 2019 Apr 27.</citation>
    <PMID>31036468</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
    <investigator_full_name>Ying Lin</investigator_full_name>
    <investigator_title>Vice Director of Department of Breast Surgery</investigator_title>
  </responsible_party>
  <keyword>Tucidinostat</keyword>
  <keyword>Estrogen Receptor-Positive</keyword>
  <keyword>Neoadjuvant endocrine therapy</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>Exemestane</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/NCT04465097
org study id: 20200628GD
nct id: NCT04465097
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to evaluate the efficacy of tucidinostat combined with exemestane as
      neoadjuvant strategy in estrogen receptor-positive early breast cancer patients and explore
      the genetic model which can predict neoadjuvant endocrine therapeutic results.
This study is to evaluate the efficacy of tucidinostat combined with exemestane as
      neoadjuvant strategy in estrogen receptor-positive early breast cancer patients.This study
      will recruit 30 patients. The 30 patients will receive 25 mg exemestane QD for 26 weeks.
      Tucidinostat will be prescribed 30 mg BIW from week 3 to week 26. During neoadjuvant
      treatment biopsy, CEUS and MRI will be perfomed according to protocol to evaluate the
      therapeutic results. Genetic testing will also be performed before and after neoadjuvant
      treatment to explore the predictive value. MRI evaluated ORR is primary end point. CEUS
      evaluated ORR, pCR, AE and RCB are secondary end point.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: objective response rate (ORR) evaluated by MRI
time frame: Up to 31 weeks
description: ORR is defined as percentage of participants with Complete Response and Partial Response, assessed by the investigators using MRI according to the Response Evaluation Criteria in Solid Tumors (RECIST)
measure: objective response rate (ORR) evaluated by CEUS
time frame: Up to 31 weeks
description: Contrast-enhanced ultrasound will also be performed to assess ORR
measure: pathologic complete response rate (pCR)
time frame: Up to 31 weeks
description: The percentage of participants with pathologically assessed ypT0 and ypTis of breast disease.
measure: Adverse effect (AE)
time frame: Up to 31 weeks
description: All advese effect events related with Tucidinostat and Exemestane.
measure: Residual Cancer Burden (RCB)
time frame: Up to 31 weeks
description: Pathologilly assessed residual cancer burden according to MD Anderson protocol.
arm group label: Tucidinostat and Exemestane
arm group type: Experimental
description: Patients receive exemestane from week 1 to week 26 and Tucidinostat BIW from week 3 to week 26. Courses continue in the absence of disease progression or unacceptable toxicity. If the patient is premenopausal, leuprorelin or goserelin will be prescribed.
intervention type: Drug
intervention name: Tucidinostat
description: Tucidinostat: 30 mg BIW (Monday and Thursday) from week 3 to week 26
arm group label: Tucidinostat and Exemestane
other name: Chidamide
other name: Epidaza
intervention type: Drug
intervention name: Exemestane
description: Exemestane: 25 mg QD from week 1 to week 26.
arm group label: Tucidinostat and Exemestane
intervention type: Drug
intervention name: Ovarian function suppression
description: If the patient is premenopausal, leuprorelin 3.75mg or goserelin 3.6 mg will be injected every 28 days.
arm group label: Tucidinostat and Exemestane
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ying Lin, MD
role: Principal Investigator
affiliation: First Affiliated Hospital, Sun Yat-Sen University
last name: Ying Lin, MD
phone: +8602087755766
phone ext: 8212
email: frostlin@hotmail.com
last name: Zhen Shan, MD
phone: +86018565396593
email: szsysu@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: China
citation: Jiang Z, Li W, Hu X, Zhang Q, Sun T, Cui S, Wang S, Ouyang Q, Yin Y, Geng C, Tong Z, Cheng Y, Pan Y, Sun Y, Wang H, Ouyang T, Gu K, Feng J, Wang X, Wang S, Liu T, Gao J, Cristofanilli M, Ning Z, Lu X. Tucidinostat plus exemestane for postmenopausal patients with advanced, hormone receptor-positive breast cancer (ACE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Jun;20(6):806-815. doi: 10.1016/S1470-2045(19)30164-0. Epub 2019 Apr 27.
PMID: 31036468
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital, Sun Yat-Sen University
investigator full name: Ying Lin
investigator title: Vice Director of Department of Breast Surgery
mesh term: Breast Neoplasms
mesh term: Exemestane
sharing ipd: No