<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/NCT03304756</url>
  </required_header>
  <id_info>
    <org_study_id>Prot 82-07</org_study_id>
    <nct_id>NCT03304756</nct_id>
  </id_info>
  <brief_title>Study of Neoadjuvant Treatment of Locally Advanced Breast Cancer With CAP Regimen</brief_title>
  <acronym>CAPneo</acronym>
  <official_title>Phase II Study of Neoadjuvant Treatment of Locally Advanced Breast Cancer Patients With the CAP Regimen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Cancer, Brazil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Nacional de Cancer, Brazil</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single arm, single center, non-randomized, phase II trial of stage IIB/III TNBC.&#xD;
      Patients received neoadjuvant chemotherapy with cisplatin (50 mg/m2) in combination with&#xD;
      doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6&#xD;
      cycles. After surgery, adjuvant chemotherapy consisting of docetaxel (75 mg/m2) every 21 days&#xD;
      was further provided for 4 cycles. Primary outcome was pathological complete response in the&#xD;
      breast and axilla (pCR; ypT0ypN0). Secondary outcomes were safety, disease-free survival and&#xD;
      overall survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a non-randomized, open-label, single arm, single center, phase II clinical trial.&#xD;
      Patients received neoadjuvant chemotherapy with cisplatin (50 mg/m2, intravenous [IV], day 1)&#xD;
      in combination with doxorubicin (50 mg/m2, IV, day 1) and cyclophosphamide (500 mg/m2, IV,&#xD;
      day 1) every 21 days and for a total of 6 cycles (CAP regimen). Subsequent mastectomy plus&#xD;
      axillary lymph node dissection was performed. Pathological specimen was analyzed to assess&#xD;
      tumor response in the breast and axilla. Adjuvant chemotherapy consisting of docetaxel (75&#xD;
      mg/m2, IV) every 21 days was further provided for 4 cycles. In case of tumor progression&#xD;
      during neoadjuvant treatment, CAP was discontinued and additional local or systemic treatment&#xD;
      was provided at the discretion of the investigator. The protocol was approved by the&#xD;
      institutional review board of National Cancer Institute - Brazil. All patients provided&#xD;
      written informed consent. The Brazilian Group of Breast Cancer Studies (GBECAM) and National&#xD;
      Cancer Institute -Brazil were the academic sponsors and National Cancer Institute- Brazil was&#xD;
      the funding source of the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 15, 2007</start_date>
  <completion_date type="Actual">December 15, 2014</completion_date>
  <primary_completion_date type="Actual">April 15, 2012</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>Pathological complete response (pCR)</measure>
    <time_frame>6 months</time_frame>
    <description>Pathological complete response (pCR) assessed by the local pathology lab, and defined as the absence of tumor (invasive and/or in situ) both in the breast and axilla (ypT0 ypN0)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety assessed according to NCI CTCAE</measure>
    <time_frame>5 years follow-up</time_frame>
    <description>Safety was assessed according to NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 3.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival (DFS)</measure>
    <time_frame>5 years follow-up</time_frame>
    <description>DFS was defined as time from surgery to disease recurrence or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>5 years follow-up</time_frame>
    <description>OS was defined as time from surgery to death from any cause.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Triple Negative Breast Cancer Patients</condition>
  <arm_group>
    <arm_group_label>CAP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cisplatin (50 mg/m2) in combination with doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6 cycles</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CAP</intervention_name>
    <description>cisplatin (50 mg/m2) in combination with doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6 cycles</description>
    <arm_group_label>CAP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female patients with locally advanced breast cancer (stages IIB, IIIA and IIIB),&#xD;
             confirmed anatomopathologically, with hormonal receptors (Estrogen and / or&#xD;
             progesterone) and ERBB2 negative to the immunohistochemical study pattern.&#xD;
&#xD;
          2. Presence of measurable disease according to RECIST criteria.&#xD;
&#xD;
          3. Staging with chest X-ray, abdominal ultrasound and bone scintigraphy Without evidence&#xD;
             of metastatic disease. Capture in bone scintigraphy should be Evaluated by simple&#xD;
             radiographs.&#xD;
&#xD;
          4. Performance Status (PS) of Eastern Cooperative Oncology Group (ECOG) ≤ 2.&#xD;
&#xD;
          5. Adequate haematological function, evidenced by higher hemoglobin level Than 9 g / dl,&#xD;
             neutrophil count greater than 1,500 / mm 3 and platelet count greater than 100,000 /&#xD;
             mm 3.&#xD;
&#xD;
          6. Adequate liver function, evidenced by bilirubin levels below 1.5 of normal values and&#xD;
             liver enzyme levels less than 2.5 times normal.&#xD;
&#xD;
          7. Adequate renal function, evidenced by creatinine levels lower than 1.5 times normal&#xD;
             value and / or estimated creatinine clearance (Cockroft) greater than 50 ml / min.&#xD;
&#xD;
          8. Preserved cardiac function assessed by Doppler echocardiography.&#xD;
&#xD;
          9. Socio-cultural ability to understand a clinical study and the need to Attend regularly&#xD;
             for medical examinations and appointments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a history of previous neoplasia, except non melanoma skin cancer.&#xD;
&#xD;
          2. Previously treatment of breast cancer with surgery, chemotherapy or Hormone therapy.&#xD;
&#xD;
          3. Presence of metastatic disease&#xD;
&#xD;
          4. Concomitant malignant neoplasm (including contralateral breast).&#xD;
&#xD;
          5. Presence of uncontrolled heart, kidney or lung disease.&#xD;
&#xD;
          6. Presence of uncontrolled diabetes mellitus.&#xD;
&#xD;
          7. Pregnancy&#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>José Bines, Doctorate</last_name>
    <role>Study Chair</role>
    <affiliation>Instituto Nacional de Cancer</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Otto Metzger, Oncologist</last_name>
    <role>Study Director</role>
    <affiliation>Medical oncologist in Boston, and affiliated with Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>José Bines, Doctorate</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Cancer</affiliation>
  </overall_official>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>October 23, 2017</last_update_submitted>
  <last_update_submitted_qc>October 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Cancer, Brazil</investigator_affiliation>
    <investigator_full_name>José Bines</investigator_full_name>
    <investigator_title>Oncologist</investigator_title>
  </responsible_party>
  <keyword>locally advanced breast cancer</keyword>
  <keyword>triple negative</keyword>
  <keyword>cisplatin</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All data from this study was monitored by the GBECAM (Brazilian Group of studies on breast cancer) and the protocol approved by the research ethics committee of the National Cancer Institute.&#xD;
The collected data are archived in the research center, available for consultation in individual clinical records by patients, in addition to the source documents and folders with all regulatory material of the study.&#xD;
We are in the process of finalizing a scientific paper, to be published in an international magazine, in order to disseminate the results of the study.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </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/NCT03304756
org study id: Prot 82-07
nct id: NCT03304756
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a single arm, single center, non-randomized, phase II trial of stage IIB/III TNBC.
      Patients received neoadjuvant chemotherapy with cisplatin (50 mg/m2) in combination with
      doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6
      cycles. After surgery, adjuvant chemotherapy consisting of docetaxel (75 mg/m2) every 21 days
      was further provided for 4 cycles. Primary outcome was pathological complete response in the
      breast and axilla (pCR; ypT0ypN0). Secondary outcomes were safety, disease-free survival and
      overall survival.
This is a non-randomized, open-label, single arm, single center, phase II clinical trial.
      Patients received neoadjuvant chemotherapy with cisplatin (50 mg/m2, intravenous [IV], day 1)
      in combination with doxorubicin (50 mg/m2, IV, day 1) and cyclophosphamide (500 mg/m2, IV,
      day 1) every 21 days and for a total of 6 cycles (CAP regimen). Subsequent mastectomy plus
      axillary lymph node dissection was performed. Pathological specimen was analyzed to assess
      tumor response in the breast and axilla. Adjuvant chemotherapy consisting of docetaxel (75
      mg/m2, IV) every 21 days was further provided for 4 cycles. In case of tumor progression
      during neoadjuvant treatment, CAP was discontinued and additional local or systemic treatment
      was provided at the discretion of the investigator. The protocol was approved by the
      institutional review board of National Cancer Institute - Brazil. All patients provided
      written informed consent. The Brazilian Group of Breast Cancer Studies (GBECAM) and National
      Cancer Institute -Brazil were the academic sponsors and National Cancer Institute- Brazil was
      the funding source of the trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pathological complete response (pCR)
time frame: 6 months
description: Pathological complete response (pCR) assessed by the local pathology lab, and defined as the absence of tumor (invasive and/or in situ) both in the breast and axilla (ypT0 ypN0)
measure: Safety assessed according to NCI CTCAE
time frame: 5 years follow-up
description: Safety was assessed according to NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 3.0.
measure: Disease-free survival (DFS)
time frame: 5 years follow-up
description: DFS was defined as time from surgery to disease recurrence or death from any cause
measure: Overall survival (OS)
time frame: 5 years follow-up
description: OS was defined as time from surgery to death from any cause.
arm group label: CAP
arm group type: Experimental
description: Cisplatin (50 mg/m2) in combination with doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6 cycles
intervention type: Drug
intervention name: CAP
description: cisplatin (50 mg/m2) in combination with doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6 cycles
arm group label: CAP
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: José Bines, Doctorate
role: Study Chair
affiliation: Instituto Nacional de Cancer
last name: Otto Metzger, Oncologist
role: Study Director
affiliation: Medical oncologist in Boston, and affiliated with Dana-Farber Cancer Institute
last name: José Bines, Doctorate
role: Principal Investigator
affiliation: Instituto Nacional de Cancer
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Cancer, Brazil
investigator full name: José Bines
investigator title: Oncologist
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms
sharing ipd: Yes
ipd description: All data from this study was monitored by the GBECAM (Brazilian Group of studies on breast cancer) and the protocol approved by the research ethics committee of the National Cancer Institute.
The collected data are archived in the research center, available for consultation in individual clinical records by patients, in addition to the source documents and folders with all regulatory material of the study.
We are in the process of finalizing a scientific paper, to be published in an international magazine, in order to disseminate the results of the study.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)