<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/NCT03821454</url>
  </required_header>
  <id_info>
    <org_study_id>CALORIE</org_study_id>
    <nct_id>NCT03821454</nct_id>
  </id_info>
  <brief_title>Capecitabine in the Treatment of Breast Cancer With Low-hormone Receptor Expression After Neoadjuvant Chemotherapy</brief_title>
  <acronym>CALORIE</acronym>
  <official_title>A Randomized, Double-blind, Placebo-controlled Study of Capecitabine in the Treatment of Early-stage Breast Cancer With Low-hormone Receptor Expression and Residual Invasive Carcinoma After Neoadjuvant Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhejiang Cancer Hospital</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>
      Capecitabine is recommended for adjuvant treatment of advanced or metastatic breast cancer&#xD;
      and is particularly effective in patients with triple-negative breast cancer (TNBC).&#xD;
&#xD;
      CREATE-X clinical studies have demonstrated that Capecitabine can further improve prognosis&#xD;
      and demonstrate good tolerance in patients who have not achieved pathologic complete response&#xD;
      (pCR) after neoadjuvant chemotherapy.&#xD;
&#xD;
      Previous studies have confirmed that the pathological features of the low- hormone receptor&#xD;
      (HR)positive population in breast cancer are similar to those in the TNBC population, with a&#xD;
      poor prognosis and are not sensitive to adjuvant endocrine therapy.&#xD;
&#xD;
      We hypothesize that the use of Capecitabine in breast cancer patients with residual invasive&#xD;
      carcinoma after neoadjuvant chemotherapy may improve prognosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will recruit patients who had low- hormone receptor (HR)positive breast&#xD;
      cancer of stage I - IIIC and pathologically assessed residual cancer cells (no pathological&#xD;
      complete response, non-pCR) after neoadjuvant chemotherapy with anthracycline, taxane, or&#xD;
      both. Participants who have residual components of ductal carcinoma in situ are assessed as&#xD;
      having a pathological complete response. Participants with tumor-positive lymph nodes&#xD;
      excluded.&#xD;
&#xD;
      Other key eligibility criteria are low- hormone receptor (HR)positive, including low-ER and&#xD;
      low-PR, low-ER and PR-negative, low-PR and ER-negative. The definition of low hormone&#xD;
      receptor (HR) positive is nuclear staining of 1%-10% of the epithelial component of the&#xD;
      tumor.&#xD;
&#xD;
      Eligible participants are centrally enrolled after pathological assessment and are randomly&#xD;
      assigned in a 1:1 ratio to receive either capecitabine plus standard therapy or standard&#xD;
      therapy alone (control).&#xD;
&#xD;
      The trial treatments are standard postsurgical treatments, which included endocrine therapy&#xD;
      in participants with estrogen-receptor-positive (nuclear staining ≥ 1%) disease, targeted&#xD;
      therapy in participants with HER-2 overexpression and radiotherapy (if indicated), with or&#xD;
      without capecitabine.&#xD;
&#xD;
      After surgery, the capecitabine group receive oral capecitabine (at a dose of 1250 mg per&#xD;
      square meter of body-surface area, twice per day, on days 1 to 14) every 3 weeks for eight&#xD;
      cycles. The concomitant administration of postsurgical endocrine therapy is allowed.&#xD;
      Postsurgical radiotherapy could be given before or after randomization and could be&#xD;
      concomitant with postsurgical endocrine therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">February 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2020</primary_completion_date>
  <phase>N/A</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Event Free Survival(DFS)</measure>
    <time_frame>Time of Surgery up to 5 years.</time_frame>
    <description>First Dose of Capecitabine or Placebo to first documentation of local or distant recurrence, or death or initiation of antineoplastic therapy before documentation of first relapse.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival(OS)</measure>
    <time_frame>First Dose of Capecitabine or Placebo up to 5 years.</time_frame>
    <description>Time from the first dose of Capecitabine or Placebo to death due to any cause.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Capecitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group received oral capecitabine for eight cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo group received oral placebo for eight cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Oral capecitabine (at a dose of 1250 mg per square meter of body-surface area, twice per day, on days 1 to 14) every 3 weeks for eight cycles.</description>
    <arm_group_label>Capecitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Oral Placebos (twice per day, on days 1 to 14) every 3 weeks for eight cycles.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of informed consent&#xD;
&#xD;
          2. Women and men at least 18 years of age or older.&#xD;
&#xD;
          3. Pathological confirmation of breast cancer&#xD;
&#xD;
          4. Tumor stage(TNM): T1-4N0-3M0&#xD;
&#xD;
          5. No evidence of distant metastasis&#xD;
&#xD;
          6. Adequate bone marrow, hepatic, and renal function&#xD;
&#xD;
          7. Measurable disease as per RECIST criteria&#xD;
&#xD;
          8. Karnofsky≥70&#xD;
&#xD;
          9. Laboratory criteria:&#xD;
&#xD;
        PLT≥100*109/L WBC≥4000/mm3 HGB≥10g/dl ALT and AST&lt;2*ULN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of metastatic disease.&#xD;
&#xD;
          2. Inflammatory breast cancer.&#xD;
&#xD;
          3. Bilateral breast cancer.&#xD;
&#xD;
          4. Postoperative treatment with other adjuvant chemotherapy drugs.&#xD;
&#xD;
          5. Other malignant tumors (concurrent or previous).&#xD;
&#xD;
          6. Pregnant woman.&#xD;
&#xD;
          7. Hypersensitive to any drug in Capecitabine or any ingredient of Capecitabine.&#xD;
&#xD;
          8. Any severe systemic disease contraindicating chemotherapy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ding Xiaowen, DR.</last_name>
    <phone>+86 13588054604</phone>
    <email>dingxw@zjcc.org.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ding Yuqin</last_name>
    <phone>+86 13588255651</phone>
    <email>13588255651@163.com</email>
  </overall_contact_backup>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 26, 2019</study_first_submitted>
  <study_first_submitted_qc>January 26, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Capecitabine</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/NCT03821454
org study id: CALORIE
nct id: NCT03821454
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Capecitabine is recommended for adjuvant treatment of advanced or metastatic breast cancer
      and is particularly effective in patients with triple-negative breast cancer (TNBC).

      CREATE-X clinical studies have demonstrated that Capecitabine can further improve prognosis
      and demonstrate good tolerance in patients who have not achieved pathologic complete response
      (pCR) after neoadjuvant chemotherapy.

      Previous studies have confirmed that the pathological features of the low- hormone receptor
      (HR)positive population in breast cancer are similar to those in the TNBC population, with a
      poor prognosis and are not sensitive to adjuvant endocrine therapy.

      We hypothesize that the use of Capecitabine in breast cancer patients with residual invasive
      carcinoma after neoadjuvant chemotherapy may improve prognosis.
The investigators will recruit patients who had low- hormone receptor (HR)positive breast
      cancer of stage I - IIIC and pathologically assessed residual cancer cells (no pathological
      complete response, non-pCR) after neoadjuvant chemotherapy with anthracycline, taxane, or
      both. Participants who have residual components of ductal carcinoma in situ are assessed as
      having a pathological complete response. Participants with tumor-positive lymph nodes
      excluded.

      Other key eligibility criteria are low- hormone receptor (HR)positive, including low-ER and
      low-PR, low-ER and PR-negative, low-PR and ER-negative. The definition of low hormone
      receptor (HR) positive is nuclear staining of 1%-10% of the epithelial component of the
      tumor.

      Eligible participants are centrally enrolled after pathological assessment and are randomly
      assigned in a 1:1 ratio to receive either capecitabine plus standard therapy or standard
      therapy alone (control).

      The trial treatments are standard postsurgical treatments, which included endocrine therapy
      in participants with estrogen-receptor-positive (nuclear staining ≥ 1%) disease, targeted
      therapy in participants with HER-2 overexpression and radiotherapy (if indicated), with or
      without capecitabine.

      After surgery, the capecitabine group receive oral capecitabine (at a dose of 1250 mg per
      square meter of body-surface area, twice per day, on days 1 to 14) every 3 weeks for eight
      cycles. The concomitant administration of postsurgical endocrine therapy is allowed.
      Postsurgical radiotherapy could be given before or after randomization and could be
      concomitant with postsurgical endocrine therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Event Free Survival(DFS)
time frame: Time of Surgery up to 5 years.
description: First Dose of Capecitabine or Placebo to first documentation of local or distant recurrence, or death or initiation of antineoplastic therapy before documentation of first relapse.
measure: Overall Survival(OS)
time frame: First Dose of Capecitabine or Placebo up to 5 years.
description: Time from the first dose of Capecitabine or Placebo to death due to any cause.
arm group label: Capecitabine
arm group type: Experimental
description: The experimental group received oral capecitabine for eight cycles.
arm group label: Placebo
arm group type: Placebo Comparator
description: The placebo group received oral placebo for eight cycles.
intervention type: Drug
intervention name: Capecitabine
description: Oral capecitabine (at a dose of 1250 mg per square meter of body-surface area, twice per day, on days 1 to 14) every 3 weeks for eight cycles.
arm group label: Capecitabine
intervention type: Drug
intervention name: Placebos
description: Oral Placebos (twice per day, on days 1 to 14) every 3 weeks for eight cycles.
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ding Xiaowen, DR.
phone: +86 13588054604
email: dingxw@zjcc.org.cn
last name: Ding Yuqin
phone: +86 13588255651
email: 13588255651@163.com
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Capecitabine
sharing ipd: No