<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/NCT01689610</url>
  </required_header>
  <id_info>
    <org_study_id>IOM-02240</org_study_id>
    <nct_id>NCT01689610</nct_id>
  </id_info>
  <brief_title>Non-interventional Study With Nab-Paclitaxel (Abraxane®)</brief_title>
  <acronym>NABUCCO</acronym>
  <official_title>Non-Interventional Study to Investigate Efficacy and Safety of Nab-Paclitaxel in Patients With Metastatic Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>iOMEDICO AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>iOMEDICO AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this non-interventional study is to collect data on the efficacy and safety of&#xD;
      Nab-Paclitaxel in the routine application.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main focus of this non-interventional study is set on answering the following questions:&#xD;
&#xD;
        -  Can the results observed in controlled clinical trials regarding efficacy and safety be&#xD;
           reproduced in the routine clinical setting?&#xD;
&#xD;
        -  Are the side-effects of nab-paclitaxel therapy observed in this study comparable to the&#xD;
           previously described safety-profile in terms of frequency and intensity?&#xD;
&#xD;
        -  What are the main reasons for modification or termination of the nab-paclitaxel therapy?&#xD;
&#xD;
        -  How does nab-paclitaxel therapy influence the patients' quality of life?&#xD;
&#xD;
        -  What are the criteria for selecting nab-paclitaxel as therapy for metastatic breast&#xD;
           cancer?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Tumor Progression (TTP)</measure>
    <time_frame>6 months after last-patient-in (LPI)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>6 months after last-patient-in (LPI)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>6 months after last-patient-in (LPI)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to treatment discontinuation</measure>
    <time_frame>6 months after last-patient-in (LPI)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Adverse Events as a measure of safety and tolerability</measure>
    <time_frame>Until 30 days after discontinuation of Nab-paclitaxel</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative dosage of Nab-Paclitaxel</measure>
    <time_frame>Until discontinuation of Nab-Paclitaxel, up to 6 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of peripheral neuropathy</measure>
    <time_frame>Until discontinuation of Nab-Paclitaxel, up to 6 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of neutropenia</measure>
    <time_frame>Until discontinuation of Nab-Paclitaxel, up to 6 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Necessity of supportive medication (e.g. haematopoetic growth factors, analgetics, antibiotics and antiemetics)</measure>
    <time_frame>Until discontinuation of Nab-Paclitaxel, up to 6 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome on Quality of life and adverse events</measure>
    <time_frame>At baseline, 3 and 6 months after start of treatment</time_frame>
    <description>Assessed by questionnaires FACT-G, FACT-B, FACT-Taxanes and a pain questionnaire of the Robert-Koch-Institute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons for dose modifications or discontinuation of treatment</measure>
    <time_frame>Until discontinuation of Nab-Paclitaxel, up to 6 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of febrile neutropenia</measure>
    <time_frame>Until discontinuation of Nab-Paclitaxel, up to 6 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of peripheral neuropathy</measure>
    <time_frame>Until discontinuation of Nab-Paclitaxel, up to 6 month</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">705</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Adult female patients with MBC</arm_group_label>
    <description>This is an observational study, no interventions are specified</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult female patients with metastatic breast cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female Patients with metastatic breast cancer, who are at least 18 years old (no upper&#xD;
             age limit)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication according to the summary of product characteristics of Abraxane®&#xD;
&#xD;
          -  No signed patient informed consent form available&#xD;
&#xD;
          -  pregnant or breastfeeding patients.&#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>Christoph Salat, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Haemato-Onkologische Schwerpunktpraxis Franz-Schrank-Strasse 2 80638 Munich, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>iOMEDICO AG</name>
      <address>
        <city>Freiburg</city>
        <state>Baden-Wuerttemberg</state>
        <zip>79108</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>June 19, 2018</last_update_submitted>
  <last_update_submitted_qc>June 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nab-Paclitaxel</keyword>
  <keyword>Abraxane</keyword>
  <keyword>Nabucco</keyword>
  <keyword>safety</keyword>
  <keyword>breast cancer</keyword>
  <keyword>daily routine</keyword>
  <keyword>peripheral neuropathy</keyword>
  <keyword>iOMEDICO</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT01689610
org study id: IOM-02240
nct id: NCT01689610
lead sponsor: 
has dmc: No
The purpose of this non-interventional study is to collect data on the efficacy and safety of
      Nab-Paclitaxel in the routine application.
The main focus of this non-interventional study is set on answering the following questions:

        -  Can the results observed in controlled clinical trials regarding efficacy and safety be
           reproduced in the routine clinical setting?

        -  Are the side-effects of nab-paclitaxel therapy observed in this study comparable to the
           previously described safety-profile in terms of frequency and intensity?

        -  What are the main reasons for modification or termination of the nab-paclitaxel therapy?

        -  How does nab-paclitaxel therapy influence the patients' quality of life?

        -  What are the criteria for selecting nab-paclitaxel as therapy for metastatic breast
           cancer?
observational model: Cohort
time perspective: Prospective
measure: Time to Tumor Progression (TTP)
time frame: 6 months after last-patient-in (LPI)
measure: Overall Response Rate (ORR)
time frame: 6 months after last-patient-in (LPI)
measure: Overall survival (OS)
time frame: 6 months after last-patient-in (LPI)
measure: Time to treatment discontinuation
time frame: 6 months after last-patient-in (LPI)
measure: Number of participants with Adverse Events as a measure of safety and tolerability
time frame: Until 30 days after discontinuation of Nab-paclitaxel
measure: Relative dosage of Nab-Paclitaxel
time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month
measure: Intensity of peripheral neuropathy
time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month
measure: Occurence of neutropenia
time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month
measure: Necessity of supportive medication (e.g. haematopoetic growth factors, analgetics, antibiotics and antiemetics)
time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month
measure: Patient reported outcome on Quality of life and adverse events
time frame: At baseline, 3 and 6 months after start of treatment
description: Assessed by questionnaires FACT-G, FACT-B, FACT-Taxanes and a pain questionnaire of the Robert-Koch-Institute.
measure: Reasons for dose modifications or discontinuation of treatment
time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month
measure: Occurence of febrile neutropenia
time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month
measure: Occurence of peripheral neuropathy
time frame: Until discontinuation of Nab-Paclitaxel, up to 6 month
arm group label: Adult female patients with MBC
description: This is an observational study, no interventions are specified
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christoph Salat, Prof.
role: Principal Investigator
affiliation: Haemato-Onkologische Schwerpunktpraxis Franz-Schrank-Strasse 2 80638 Munich, Germany
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Breast Neoplasms