<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/NCT03756090</url>
  </required_header>
  <id_info>
    <org_study_id>PECP</org_study_id>
    <nct_id>NCT03756090</nct_id>
  </id_info>
  <brief_title>The Combination of Palbociclib With ddEC-P as Neoadjuvant Therapy in Triple Negative Breast Cancer</brief_title>
  <acronym>PECP</acronym>
  <official_title>A Randomized Study Evaluating the Safety and Effects of the Combination of Palbociclib With Epirubicin and Cyclophosphamide Followed by Paclitaxel as Neoadjuvant Therapy in Triple Negative Breast Cancer</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>
      This study will look at effects the combination of palbociclib and dose-dense neoadjuvant&#xD;
      chemotherapy may have on triple negative breast cancer tumours which have not yet been&#xD;
      treated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be randomized to one of two treatment arms (1:1 ratio). Dose-Dense neoadjuvant&#xD;
      chemotherapy in the first 8 weeks of will be: epirubicin (90mg/m2) and cyclophosphamide&#xD;
      (600mg/m2), followed by paclitaxel (80mg / m2) after 8 weeks, cycled every 14 days for total&#xD;
      8 cycles.&#xD;
&#xD;
      Palbociclib will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21&#xD;
      days) on, 1 week (7 days) off of a 4 week [28 days] cycle.&#xD;
&#xD;
      Arm I: Palbociclib combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.&#xD;
&#xD;
      Arm II: Placebo combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.&#xD;
&#xD;
      Note:&#xD;
&#xD;
      Following completion of study therapy, surgery will be scheduled for 18-20 weeks&#xD;
      post-randomization.&#xD;
&#xD;
      Post-surgical treatment will be at the discretion of treating clinician, following&#xD;
      postoperative pathology.&#xD;
&#xD;
      After week 16 (end of study therapy) all patients should continue Palbociclib for one year.&#xD;
&#xD;
      Toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology&#xD;
      Criteria for Adverse Events version 4.0 (CTCAE v4.0).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2018</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</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>pCR</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DFS</measure>
    <time_frame>Following surgery until Year 3</time_frame>
    <description>Disease-free Survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>Objective Response Rate (ORR) during neoadjuvant period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AEs</measure>
    <time_frame>baseline and weekly through 12 months after randomization</time_frame>
    <description>Number and severity of adverse events.Toxicity will be graded according to the National Cancer Institute (NCI) 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">100</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Breast Diseases</condition>
  <condition>Breast Neoplasms</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm I: Palbociclib combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Arm II: Placebo combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Palbociclib</intervention_name>
    <description>Palbociclib will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21 days) on, 1 week (7 days) off of a 4 week [28 days] cycle.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>Placebo oral capsule will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21 days) on, 1 week (7 days) off of a 4 week [28 days] cycle.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epirubicin</intervention_name>
    <description>Epirubicin (90mg/m2, D1) cycled every 14 days for the first 4 cycles.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Cyclophosphamide (600mg/m2, D1) cycled every 14 days for the first 4 cycles.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Paclitaxel (80mg/m2, D1) cycled every 14 days for the later 4 cycles.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. female patients, 18 years ≤ age ≤ 80 years；&#xD;
&#xD;
          2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1&#xD;
&#xD;
          3. Histologically confirmed invasive breast cancer（early stage or locally advanced）&#xD;
&#xD;
          4. HER2 negative (HER2+/- by IHC or FISH-)&#xD;
&#xD;
          5. Hormone receptor (ER and PR) negative&#xD;
&#xD;
          6. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by&#xD;
             ECHO&#xD;
&#xD;
          7. Signed informed consent form (ICF)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Metastatic disease (Stage IV) or inflammatory breast cancer&#xD;
&#xD;
          2. Previous or current history of malignant neoplasms, except for curatively treated:&#xD;
             Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix.&#xD;
&#xD;
          3. Clinically relevant cardiovascular disease: Known history of uncontrolled or&#xD;
             symptomatic angina, clinically significant arrhythmias, congestive heart failure,&#xD;
             transmural myocardial infarction, uncontrolled hypertension ≥180/110);&#xD;
&#xD;
          4. Unable or unwilling to swallow capsules.&#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_official>
    <last_name>Ding Xiaowen, DR.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhejiang Cancer Hospital</affiliation>
  </overall_official>
  <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>November 2018</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>December 6, 2018</last_update_submitted>
  <last_update_submitted_qc>December 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</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>
    <mesh_term>Breast Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Epirubicin</mesh_term>
    <mesh_term>Palbociclib</mesh_term>
  </intervention_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/NCT03756090
org study id: PECP
nct id: NCT03756090
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will look at effects the combination of palbociclib and dose-dense neoadjuvant
      chemotherapy may have on triple negative breast cancer tumours which have not yet been
      treated.
Patients will be randomized to one of two treatment arms (1:1 ratio). Dose-Dense neoadjuvant
      chemotherapy in the first 8 weeks of will be: epirubicin (90mg/m2) and cyclophosphamide
      (600mg/m2), followed by paclitaxel (80mg / m2) after 8 weeks, cycled every 14 days for total
      8 cycles.

      Palbociclib will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21
      days) on, 1 week (7 days) off of a 4 week [28 days] cycle.

      Arm I: Palbociclib combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.

      Arm II: Placebo combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.

      Note:

      Following completion of study therapy, surgery will be scheduled for 18-20 weeks
      post-randomization.

      Post-surgical treatment will be at the discretion of treating clinician, following
      postoperative pathology.

      After week 16 (end of study therapy) all patients should continue Palbociclib for one year.

      Toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology
      Criteria for Adverse Events version 4.0 (CTCAE v4.0).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: pCR
time frame: Through study completion, an average of 1 year.
description: Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery.
measure: DFS
time frame: Following surgery until Year 3
description: Disease-free Survival
measure: ORR
time frame: Through study completion, an average of 1 year.
description: Objective Response Rate (ORR) during neoadjuvant period
measure: AEs
time frame: baseline and weekly through 12 months after randomization
description: Number and severity of adverse events.Toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
arm group label: Experimental group
arm group type: Experimental
description: Arm I: Palbociclib combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
arm group label: Control group
arm group type: Placebo Comparator
description: Arm II: Placebo combined with Dose-Dense neoadjuvant chemotherapy for total 16 weeks.
intervention type: Drug
intervention name: Palbociclib
description: Palbociclib will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21 days) on, 1 week (7 days) off of a 4 week [28 days] cycle.
arm group label: Experimental group
intervention type: Drug
intervention name: Placebo oral capsule
description: Placebo oral capsule will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21 days) on, 1 week (7 days) off of a 4 week [28 days] cycle.
arm group label: Control group
intervention type: Drug
intervention name: Epirubicin
description: Epirubicin (90mg/m2, D1) cycled every 14 days for the first 4 cycles.
arm group label: Control group
arm group label: Experimental group
intervention type: Drug
intervention name: Cyclophosphamide
description: Cyclophosphamide (600mg/m2, D1) cycled every 14 days for the first 4 cycles.
arm group label: Control group
arm group label: Experimental group
intervention type: Drug
intervention name: Paclitaxel
description: Paclitaxel (80mg/m2, D1) cycled every 14 days for the later 4 cycles.
arm group label: Control group
arm group label: Experimental group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ding Xiaowen, DR.
role: Principal Investigator
affiliation: Zhejiang Cancer Hospital
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: Triple Negative Breast Neoplasms
mesh term: Breast Diseases
mesh term: Paclitaxel
mesh term: Cyclophosphamide
mesh term: Epirubicin
mesh term: Palbociclib
sharing ipd: Undecided