<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/NCT04403529</url>
  </required_header>
  <id_info>
    <org_study_id>ZY(2018-2020)-CCCX-2005-04</org_study_id>
    <nct_id>NCT04403529</nct_id>
  </id_info>
  <brief_title>Evaluating the Clinical Value of Traditional Chinese Medicine in the Adjuvant Therapy of Triple-negative Breast Cancer</brief_title>
  <official_title>Evaluating the Clinical Value of Traditional Chinese Medicine in the Adjuvant Therapy of Triple-negative Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, single site, randomized, double-blind Phase III clinical trial to&#xD;
      evaluate the clinical value of Traditional Chinese Medicine in the adjuvant therapy of&#xD;
      triple-negative breast cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in quality of life scores as assessed by EORTC QLQ-C30</measure>
    <time_frame>2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.</time_frame>
    <description>Difference in quality of life scores as assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Higher scores mean a better outcome. An higher scores after treatment compared to baseline mean a better outcome or improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in quality of life scores as assessed by EORTC QLQ-BR23</measure>
    <time_frame>2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.</time_frame>
    <description>Difference in quality of life scores as assessed by European Organisation for Research and Treatment of Cancer quality of life questionnaire-breast cancer module 23 (QLQ-BR23). Higher scores mean a better outcome. An higher scores after treatment compared to baseline mean a better outcome or improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Local recurrence rate</measure>
    <time_frame>1,2,3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastasis rate</measure>
    <time_frame>1,2,3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in Syndrome of Traditional Chinese Medicine Evaluation of Traditional Chinese Medicine syndromes</measure>
    <time_frame>2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in physical fitness evaluation by Eastern Cooperative Oncology Group (ECOG) score</measure>
    <time_frame>2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.</time_frame>
    <description>Difference in physical fitness evaluation by Eastern Cooperative Oncology Group (ECOG) score, the score runs from 0 to 5, with 0 denoting perfect health and 5 death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in physical fitness evaluation by Karnofsky performance score (KPS)</measure>
    <time_frame>2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.</time_frame>
    <description>Difference in physical fitness evaluation by Karnofsky performance score (KPS), the score runs from 0 to 100, with 100 denoting perfect health and 0 death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.</time_frame>
    <description>Incidence and Severity of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0（CTCAE V4.0）</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Triple Negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Traditional Chinese Medicine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 days of oral Traditional Chinese Medicine (&quot;prescription for breast cancer&quot; Traditional Chinese Medicine formulation)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>60 days of oral placebo (placebo contains 5% &quot;prescription for breast cancer&quot; Traditional Chinese Medicine formulation and 95% filler)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Traditional Chinese Medicine Formulation</intervention_name>
    <description>The &quot;prescription for breast cancer&quot; Traditional Chinese Medicine formulation is a combination of 12 herbal components and it is available in granules form to be dissolved in hot water for consumption.</description>
    <arm_group_label>Traditional Chinese Medicine</arm_group_label>
    <other_name>&quot;prescription for breast cancer&quot; Traditional Chinese Medicine formulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Formulation</intervention_name>
    <description>Placebo granules contains 5% &quot;prescription for breast cancer&quot; Traditional Chinese Medicine formulation and 95% filler, it is available in granules form to be dissolved in hot water for consumption.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo granules contains 5% &quot;prescription for breast cancer&quot; Traditional Chinese Medicine formulation and 95% filler</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18-70 years old;&#xD;
&#xD;
          -  Pathologically confirmed stage I-III breast cancer after early breast cancer surgery,&#xD;
             and is confirmed by histopathology to be triple negative breast cancer (estrogen&#xD;
             receptor (ER)-negative/ progesterone receptor (PR)-negative/ human epidermal growth&#xD;
             factor receptor 2 (HER2)-negative). HER2-negative is defined as a negative in situ&#xD;
             hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is&#xD;
             2+, a negative in situ hybridization test is required by local laboratory testing;&#xD;
&#xD;
          -  Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; life&#xD;
             expectancy is ≥ 6 months;&#xD;
&#xD;
          -  Has adequate organ function meeting the following criteria: (1) adequate bone marrow&#xD;
             function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute&#xD;
             neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 * 109 /L; (2)adequate liver and&#xD;
             kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN),&#xD;
             Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum&#xD;
             creatinine ≤ 1×ULN，and with endogenous creatinine clearance rate of &gt;50 ml/min&#xD;
             (Cockcroft-Gault formula).&#xD;
&#xD;
          -  Participant has completed the last of their post surgical radiotherapy and&#xD;
             chemotherapy within the last 6 months before date of enrollment, and no tumor&#xD;
             recurrence or metastasis at the time of enrollment.&#xD;
&#xD;
          -  Participants voluntarily joined the study, has signed informed consent before any&#xD;
             trial related activities are conducted, has good compliance and has agreed to&#xD;
             follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has bilateral breast cancer;&#xD;
&#xD;
          -  Has previous history of additional malignancy, with the exception of adequately&#xD;
             treated basal cell carcinoma and cervical carcinoma in situ.&#xD;
&#xD;
          -  Has metastatic (Stage 4) breast cancer;&#xD;
&#xD;
          -  Has any &gt;T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and&#xD;
             inflammatory breast cancer);&#xD;
&#xD;
          -  Is pregnant, is breast feeding women, or women of childbearing age who cannot practice&#xD;
             effective contraceptives;&#xD;
&#xD;
          -  Patients participating in other drug related clinical trials at the same time;&#xD;
&#xD;
          -  Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left&#xD;
             ventricular ejection fraction (LVEF) &lt; 50% (cardiac ultrasound); severe cardio&#xD;
             cerebral vascular disease within the 6 months previous of randomization (such as&#xD;
             unstable angina, chronic heart failure, uncontrolled hypertension with blood&#xD;
             pressure&gt;150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic&#xD;
             patients with poor blood glucose control; patients with severe hypertension;&#xD;
&#xD;
          -  Has known allergy to study medication;&#xD;
&#xD;
          -  Has severe or uncontrolled infection;&#xD;
&#xD;
          -  Has a history of psychotropic substance abuse and were unable to abandon drug habits,&#xD;
             or those with history of mental disorders;&#xD;
&#xD;
          -  The researchers judged patients to be unsuitable for the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ZhiMin Shao, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ZhiMin Shao, MD, PhD</last_name>
    <phone>+86-21-64175590</phone>
    <phone_ext>8808</phone_ext>
    <email>zhimingshao@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhi-Ming Shao, MD, PhD</last_name>
      <phone>+86-021-64175590</phone>
      <phone_ext>8888</phone_ext>
      <email>zhimingshao@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Zhimin Shao</investigator_full_name>
    <investigator_title>Head of Breast Surgery Department</investigator_title>
  </responsible_party>
  <keyword>adjuvant therapy</keyword>
  <keyword>traditional chinese medicine</keyword>
  <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>
  <!-- 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/NCT04403529
org study id: ZY(2018-2020)-CCCX-2005-04
nct id: NCT04403529
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective, single site, randomized, double-blind Phase III clinical trial to
      evaluate the clinical value of Traditional Chinese Medicine in the adjuvant therapy of
      triple-negative breast cancer patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Disease free survival
time frame: 3 years
measure: Difference in quality of life scores as assessed by EORTC QLQ-C30
time frame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
description: Difference in quality of life scores as assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Higher scores mean a better outcome. An higher scores after treatment compared to baseline mean a better outcome or improvement.
measure: Difference in quality of life scores as assessed by EORTC QLQ-BR23
time frame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
description: Difference in quality of life scores as assessed by European Organisation for Research and Treatment of Cancer quality of life questionnaire-breast cancer module 23 (QLQ-BR23). Higher scores mean a better outcome. An higher scores after treatment compared to baseline mean a better outcome or improvement.
measure: Local recurrence rate
time frame: 1,2,3 years
measure: Distant metastasis rate
time frame: 1,2,3 years
measure: Overall survival
time frame: 3 years
measure: Difference in Syndrome of Traditional Chinese Medicine Evaluation of Traditional Chinese Medicine syndromes
time frame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
measure: Difference in physical fitness evaluation by Eastern Cooperative Oncology Group (ECOG) score
time frame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
description: Difference in physical fitness evaluation by Eastern Cooperative Oncology Group (ECOG) score, the score runs from 0 to 5, with 0 denoting perfect health and 5 death.
measure: Difference in physical fitness evaluation by Karnofsky performance score (KPS)
time frame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
description: Difference in physical fitness evaluation by Karnofsky performance score (KPS), the score runs from 0 to 100, with 100 denoting perfect health and 0 death.
measure: Adverse events
time frame: 2 months from baseline, and follow-up every 3 months afterwards until up to 3 years.
description: Incidence and Severity of adverse events according to the Common Terminology Criteria for Adverse Events Version 4.0（CTCAE V4.0）
arm group label: Traditional Chinese Medicine
arm group type: Experimental
description: 60 days of oral Traditional Chinese Medicine ("prescription for breast cancer" Traditional Chinese Medicine formulation)
arm group label: Placebo
arm group type: Placebo Comparator
description: 60 days of oral placebo (placebo contains 5% "prescription for breast cancer" Traditional Chinese Medicine formulation and 95% filler)
intervention type: Drug
intervention name: Traditional Chinese Medicine Formulation
description: The "prescription for breast cancer" Traditional Chinese Medicine formulation is a combination of 12 herbal components and it is available in granules form to be dissolved in hot water for consumption.
arm group label: Traditional Chinese Medicine
other name: "prescription for breast cancer" Traditional Chinese Medicine formulation
intervention type: Drug
intervention name: Placebo Formulation
description: Placebo granules contains 5% "prescription for breast cancer" Traditional Chinese Medicine formulation and 95% filler, it is available in granules form to be dissolved in hot water for consumption.
arm group label: Placebo
other name: Placebo granules contains 5% "prescription for breast cancer" Traditional Chinese Medicine formulation and 95% filler
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: ZhiMin Shao, MD, PhD
role: Principal Investigator
affiliation: Fudan University
last name: ZhiMin Shao, MD, PhD
phone: +86-21-64175590
phone ext: 8808
email: zhimingshao@yahoo.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Zhimin Shao
investigator title: Head of Breast Surgery Department
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms