<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/NCT03799692</url>
  </required_header>
  <id_info>
    <org_study_id>1808189-8</org_study_id>
    <nct_id>NCT03799692</nct_id>
  </id_info>
  <brief_title>Albumin-Bound Paclitaxel Combined With Carboplatin as Neoadjuvant Chemotherapy in Luminal B/HER-2 Negative Breast Cancer</brief_title>
  <official_title>Clinical Trial of Nanoparticle Albumin-Bound Paclitaxel Combined With Carboplatin as Neoadjuvant Chemotherapy in Luminal B/HER-2 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>
    <has_dmc>Yes</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 is an open-label, single arm, two-stage Simon Design study for women with LuminalB/HER-2&#xD;
      Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin.&#xD;
&#xD;
      The primary objective of the trial is to evaluate of the efficacy and safety of Nanoparticle&#xD;
      Albumin-Bound Paclitaxel Combined with Carboplatin as Neoadjuvant Chemotherapy in Luminal&#xD;
      B/HER-2 Negative Breast Cancer.&#xD;
&#xD;
      The primary endpoint of the study is to assess Pathological complete response rate（pCR）using&#xD;
      the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).&#xD;
&#xD;
      The total number of patients to be included in this study is 78 patients.&#xD;
&#xD;
      The duration of the study, from first patient visit to last patient visit will be&#xD;
      approximately 12 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 19, 2018</start_date>
  <completion_date type="Anticipated">July 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2019</primary_completion_date>
  <phase>Phase 4</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>The primary endpoint is pathological complete remission (pCR)</measure>
    <time_frame>3 months</time_frame>
    <description>Histopathological examination of breast and axillary lymph node specimens without invasive cancer cell remnants. Complete pathological response is also considered to be achieved if only in situ cancer cell remnants are present in the surgical specimens.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>3 months</time_frame>
    <description>The second endpoint ORR composed of tumor response classifications of complete response (CR) and partial response (PR), refers to the number of cases with complete and partial response after treatment as a percentage of the total number of evaluable cases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast conserving surgery (BCS) rate</measure>
    <time_frame>3 months</time_frame>
    <description>Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy as a whole evaluable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events (AE)</measure>
    <time_frame>3 months</time_frame>
    <description>Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Patients were assessed for toxicities before each administration, and toxicity was graded accordingly.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">78</enrollment>
  <condition>HER-2 Negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, Carboplatin AUC=2, iv, d1, 8, 15, 4 cycles (21 days per cycle).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy</intervention_name>
    <description>Drug: Nanoparticle Albumin-Bound Paclitaxel Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1, 8, 15.&#xD;
Drug: Carboplatin AUC=2 iv, d1, 8, 15.</description>
    <arm_group_label>Chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1.Age: from 18 to 70 years old, female.&#xD;
&#xD;
          -  2.Has histologically or cytologically confirmed unilateral primary invasive breast&#xD;
             cancer with a clinical stage of T2-4NanyM0.&#xD;
&#xD;
          -  3.Immunohistochemical detection of ER+, PR+, HER-2 negative (if HER2 expression is 2+&#xD;
             patients need to be confirmed by in situ hybridization to detect no HER-2 gene&#xD;
             amplification) and Ki-67 expression &gt;20% of patients;&#xD;
&#xD;
          -  4.At least one measurable objective lesion according to RECIST 1.1 criteria.&#xD;
&#xD;
          -  5.ECOG performance status of 0-1.&#xD;
&#xD;
          -  6.Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin&#xD;
             ≥ 90 g/L.&#xD;
&#xD;
          -  7.Liver and renal function: Serum creatinine ≤ 1.5 times the upper limit of normal.&#xD;
             AST and ALT ≤ 2.5 times the upper limit of normal Total bilirubin ≤ 1.5 times the&#xD;
             upper limit of normal, or ≤ 2.5 times the upper limit of normal in patients with&#xD;
             Gilbert's syndrome.&#xD;
&#xD;
          -  8.Has good compliance with the planned treatment, understand the study process and&#xD;
             sign written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1.Any prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or&#xD;
             radiation therapy.&#xD;
&#xD;
          -  2.Patients with grade II or higher heart disease scored by the New York Heart&#xD;
             Association (NYHA).&#xD;
&#xD;
          -  3.Severe systemic infection, or with other serious diseases.&#xD;
&#xD;
          -  4.Patients with known hypersensitivity or intolerance to chemotherapeutic agents or&#xD;
             their excipients.&#xD;
&#xD;
          -  5.Other malignancies have occurred in the past 5 years, except for cured cervical&#xD;
             carcinoma in situ, non-melanoma skin carcinoma.&#xD;
&#xD;
          -  6.Pregnant or lactating, and who refuse to take appropriate contraception during the&#xD;
             course of this trial.&#xD;
&#xD;
          -  7.Have participated in other study studies within 30 days prior to the first dose of&#xD;
             study drug.&#xD;
&#xD;
          -  8.Patients who, in the opinion of the Investigator, are not suitable for participation&#xD;
             in 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</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhimin Shao</last_name>
    <phone>18017312288</phone>
    <email>szm@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yin Liu</last_name>
    <phone>13818051895</phone>
    <email>liuyinfudan@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhi-Min Shao, MD.PhD.</last_name>
      <phone>13601637369</phone>
      <email>zhimingshao@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Zhi-Min Shao, MD.PhD.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Department of Breast Surgery, Cancer Hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhimin Shao</last_name>
      <phone>86(21)64175590</phone>
      <phone_ext>88807</phone_ext>
      <email>zhimingshao@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Zhimin Shao</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</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>professor</investigator_title>
  </responsible_party>
  <keyword>Neoadjuvant Chemotherapy</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/NCT03799692
org study id: 1808189-8
nct id: NCT03799692
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is an open-label, single arm, two-stage Simon Design study for women with LuminalB/HER-2
      Negative Breast Cancer treated with Nanoparticle Albumin-Bound Paclitaxel and Carboplatin.

      The primary objective of the trial is to evaluate of the efficacy and safety of Nanoparticle
      Albumin-Bound Paclitaxel Combined with Carboplatin as Neoadjuvant Chemotherapy in Luminal
      B/HER-2 Negative Breast Cancer.

      The primary endpoint of the study is to assess Pathological complete response rate（pCR）using
      the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

      The total number of patients to be included in this study is 78 patients.

      The duration of the study, from first patient visit to last patient visit will be
      approximately 12 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary endpoint is pathological complete remission (pCR)
time frame: 3 months
description: Histopathological examination of breast and axillary lymph node specimens without invasive cancer cell remnants. Complete pathological response is also considered to be achieved if only in situ cancer cell remnants are present in the surgical specimens.
measure: Objective response rate (ORR)
time frame: 3 months
description: The second endpoint ORR composed of tumor response classifications of complete response (CR) and partial response (PR), refers to the number of cases with complete and partial response after treatment as a percentage of the total number of evaluable cases.
measure: Breast conserving surgery (BCS) rate
time frame: 3 months
description: Percentage of patients undergoing breast-conserving surgery after neoadjuvant therapy as a whole evaluable.
measure: Adverse events (AE)
time frame: 3 months
description: Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. Patients were assessed for toxicities before each administration, and toxicity was graded accordingly.
arm group label: Chemotherapy
arm group type: Experimental
description: Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, Carboplatin AUC=2, iv, d1, 8, 15, 4 cycles (21 days per cycle).
intervention type: Drug
intervention name: Chemotherapy
description: Drug: Nanoparticle Albumin-Bound Paclitaxel Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1, 8, 15.
Drug: Carboplatin AUC=2 iv, d1, 8, 15.
arm group label: Chemotherapy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Zhimin Shao
role: Principal Investigator
affiliation: Fudan University
last name: Zhimin Shao
phone: 18017312288
email: szm@163.com
last name: Yin Liu
phone: 13818051895
email: liuyinfudan@163.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Zhimin Shao
investigator title: professor
mesh term: Breast Neoplasms
sharing ipd: Undecided