<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/NCT03789019</url>
  </required_header>
  <id_info>
    <org_study_id>BMC2011-02</org_study_id>
    <nct_id>NCT03789019</nct_id>
  </id_info>
  <brief_title>BP-C1 Monotherapy in Patients With Metastatic Breast Cancer Cancer: Estimation of Optimal Duration of Treatment</brief_title>
  <official_title>Estimation of the Optimal Treatment Duration and Cumulative Dose of BP-C1 in Breast Cancer Patients With Distant Metastases: a Dose-response Study (IC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meabco A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Meddoc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian University of Life Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Meabco A/S</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to establish an optimal treatment duration and tolerable&#xD;
      cumulative dose for BP-C1 in the treatment of metastatic breast cancer patients who had&#xD;
      previously undergone at least three lines of chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BP-C1, solution for injection 0.05%, is currently being developed for treatment of patients&#xD;
      with metastatic breast cancer with palliative intent. Active substance of the product, which&#xD;
      is a novel platinum-containing anticancer agent developed for intramuscular administration,&#xD;
      is cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids&#xD;
      derived from lignin. The amphiphilic characteristics of the polymer have resulted in a&#xD;
      product with clear and significantly altered and improved properties compared to other&#xD;
      platinum analogues, e.g. cisplatin, carboplatin and oxaliplatin.&#xD;
&#xD;
      BP-C1 preserves antitumour activity of its predecessors (e.g. cisplatin and carboplatin),&#xD;
      additionally offering the following advantages that ensure favourable outcome of treatment of&#xD;
      metastatic breast cancer patients:&#xD;
&#xD;
        -  injectable solution (intramuscular) does not cause injection site reactions;&#xD;
&#xD;
        -  can be administered at home by a nurse or a patient;&#xD;
&#xD;
        -  has an improved pharmacokinetic profile;&#xD;
&#xD;
        -  demonstrates efficacy comparable to cisplatin and much higher than carboplatin&#xD;
           (in-vitro; in-vivo data);&#xD;
&#xD;
        -  exerts an additional immunomodulatory activity.&#xD;
&#xD;
      This study is an open-label, non-randomised, single-group, multi-centre study with a&#xD;
      sequential safety design. The study consists of two parts: dose-response part and follow-up&#xD;
      study.&#xD;
&#xD;
      Dose-response part: Patients who have completed the first 32-day treatment period with BP-C1&#xD;
      from Day 1 to Day 32 under Protocol BMC2011-1/Protocol MBC-BPC1/IIB or Protocol BMC2012-4,&#xD;
      and having a maximum of &quot;moderate&quot; toxicity at the end of treatment are offered to continue&#xD;
      in the second 32-day treatment period with BP-C1 from Day 33 to Day 64 under protocol&#xD;
      BMC2011-02. Patients completing 64-day treatment period with BP-C1 will be followed up for 28&#xD;
      days.&#xD;
&#xD;
      Follow-up study: After 28-day follow-up period the patients without disease progression and&#xD;
      without an increase in toxicity are offered to participate in the follow-up study. During the&#xD;
      follow-up study the patients will be given BP-C1 as long as they obtain benefit from the&#xD;
      treatment (i.e. until disease progression or increase in toxicity not above &quot;moderate&quot;&#xD;
      grade).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2013</start_date>
  <completion_date type="Actual">July 29, 2016</completion_date>
  <primary_completion_date type="Actual">July 29, 2016</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>Sum Common Toxicity Criteria score (Sum CTC score)</measure>
    <time_frame>baseline to Day 64 of treatment period</time_frame>
    <description>Toxicity will be assessed according to National Cancer Institute Common Toxicity Criteria version 2.0 (CTC v2.0). The CTC v2.0 is divided in 15 toxicity categories (variables); each category is divided by corresponding sub-variables. Each sub-variable is measured on five-point fixed scale from 0 to 4: 0-none, 1-mild, 2-moderate, 3-severe, 4-life-threatening. However, in this trial each sub-variable will be measured on modified fixed scale from 1 to 4: 1-none or mild, 2-moderate, 3-severe, 4-life-threatening. The classification of each toxicity variable will be judged based on the largest observed value for its sub-variables. The Sum CTC score will be calculated by taking the sum of each variable across all categories.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Common Toxicity Criteria score (Maximum CTC score)</measure>
    <time_frame>baseline to Day 64 of treatment period</time_frame>
    <description>Toxicity will be assessed according to National Cancer Institute Common Toxicity Criteria version 2.0 (CTC v2.0). The CTC v2.0 is divided in 15 toxicity categories (variables); each category is divided by corresponding sub-variables. Each sub-variable is measured on five-point fixed scale from 0 to 4: 0-none, 1-mild, 2-moderate, 3-severe, 4-life-threatening. However, in this trial each sub-variable will be measured on modified fixed scale from 1 to 4: 1-none or mild, 2-moderate, 3-severe, 4-life-threatening. The classification of each toxicity variable will be judged based on the largest observed value for its sub-variables. The Maximum CTC score will be calculated by taking the maximum value among all variables across all categories.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change (%) in the sum of diameters of target lesions</measure>
    <time_frame>baseline to Day 64 of treatment period</time_frame>
    <description>Diameter of target lesions will be measured by computer tomography (CT) with contrasting using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment response</measure>
    <time_frame>baseline to Day 64 of treatment period</time_frame>
    <description>In accordance with RECIST v1.1 the treatment response will be classified as 'complete response', 'partial response', 'stable disease' or 'progressive disease': Complete response (CR): disappearance of all target lesions. Partial response (PR): at least 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum of diameters. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum might also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions will also be considered progression. Stable disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Karnofsky Performance Status score (KPS score)</measure>
    <time_frame>baseline to Day 64 of treatment period</time_frame>
    <description>KPS score will give an outcome with 11 grades, starting as normal status without complaints and evidence of disease as the best (KPS score = 100) and the dead status as the lowest (KPS score = 0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in sub-scores of the three major scales of general quality of life questionnaire (EORTC QLQ-C30)</measure>
    <time_frame>baseline to Day 64 of treatment period</time_frame>
    <description>Quality of life sub-scores will be obtained by general cancer questionnaire EORTC QLQ-C30. EORTC QLQ-C30 consists of 30 questions generally related to cancer. The questionnaire will be self-administered and will be given in patient's mother tongue. EORTC QLQ-C30 (version 3) is divided in the 3 major scales that will be presented as 15 sub-scores: i) global health status; ii) functional scale (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning); iii) symptom scale/item(fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties). Range of functional scale is 0-100 (high values are &quot;better&quot;). Range of symptom scale is 0-100 (low values are &quot;better&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in sub-scores of the specific quality of life questionnaire (EORTC QLQ-BR23)</measure>
    <time_frame>baseline to Day 64 of treatment period</time_frame>
    <description>Quality of life sub-scores will be obtained by specific breast cancer questionnaire EORTC QLQ-BR23. EORTC QLQ-BR-23 consists of 23 questions related to breast cancer. The questionnaire will be self-administered and will be given in patient's mother tongue. EORTC QLQ-BR23 is divided in 2 scales that will be presented as 8 sub-scores: i) functional scale (body image, sexual functioning, sexual enjoyment, future perspective); ii) symptom scale/item (systemic therapy side effect, breast symptom, arm symptom, upset by hair loss). Range of functional scale is 0-100 (high values are &quot;better&quot;). Range of symptom scale is 0-100 (low values are &quot;better&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of registered adverse events</measure>
    <time_frame>baseline to Day 28 of follow-up period</time_frame>
    <description>Adverse events (AEs) will be coded according to the MedDRA (version 16.1E). AEs will be systemized by system organ class and by preferred term. AEs will be analyzed by severity, seriousness and relatedness to the drug.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Metastatic Breast Cancer</condition>
  <condition>Stage IV Breast Cancer</condition>
  <arm_group>
    <arm_group_label>BP-C1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose-response part: patients who have completed the first 32-day treatment period with BP-C1 under Protocol BMC2011-1/Protocol MBC-BPC1/IIB or Protocol BMC2012-4, and having a maximum of &quot;moderate&quot; toxicity at the end of treatment are offered to continue in the second 32-day treatment period with BP-C1 under the protocol BMC2011-02. Patients completing 64-day treatment period with BP-C1 will be followed up for 28 days.&#xD;
Follow-up study: the patients will be given BP-C1 as long as they obtain benefit from the treatment (i.e. until disease progression or increase in toxicity not above &quot;moderate&quot; grade).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BP-C1</intervention_name>
    <description>BP-C1, 0.05% solution for injection; doses: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days</description>
    <arm_group_label>BP-C1</arm_group_label>
    <other_name>Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin</other_name>
    <other_name>Cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from lignin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Female patients who have completed 32-day treatment with BP-C1 (under protocols BMC2011-1,&#xD;
        MBC-BPC1/IIA, BMC2012-4), having increase in toxicity not above moderate level, and having&#xD;
        no progression of the disease. In accordance with inclusion criteria checked in the studies&#xD;
        BMC2011-1, MBC-BPC1/IIA, or BMC2012-4, the patients are between 18 and 80 years with&#xD;
        metastatic breast cancer (stage IV), had previously underwent at least third line&#xD;
        chemotherapy, and have an expected survival time of at least 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe or life-threatening increase in toxicity after preceding 32-day treatment with&#xD;
             BP-C1.&#xD;
&#xD;
          -  Abnormal liver function classified as total bilirubin &gt;34 μmol/L or ALAT &gt; 3 times of&#xD;
             the upper limit of normal (ULN). In case of metastases in the liver, the ALAT limit&#xD;
             for exclusion is set to 5хULN.&#xD;
&#xD;
          -  Abnormal kidney function defined by serum creatinine &gt;120 μmol/L.&#xD;
&#xD;
          -  Abnormal coagulation capacity defined by the relative arbitrary concentration of&#xD;
             coagulation factors 2,7,10 &lt;0.70 or international normalised ratio (INR) &gt;1.5.&#xD;
&#xD;
          -  Verified metastases to the brain.&#xD;
&#xD;
          -  Synchronous cancer except for non-melanoma skin cancer and early stage of cervical&#xD;
             cancer.&#xD;
&#xD;
          -  Abnormal hematology status defined by hemoglobin &lt; 9.0 g/dL, platelet count&#xD;
             &lt;100,000/mm^3 or leucocytes &lt; 3 x 10^9/L.&#xD;
&#xD;
          -  Clinically significant abnormal ECG.&#xD;
&#xD;
          -  Karnofsky performance status score &lt;60%.&#xD;
&#xD;
          -  Pregnant or breast-feeding women.&#xD;
&#xD;
          -  Women of fertile age who do not want to be tested for possible pregnancy.&#xD;
&#xD;
          -  Fertile female who do not want to use safe protection against pregnancy, starting one&#xD;
             month before the start of the study treatment and lasting at least six weeks after.&#xD;
&#xD;
          -  Uncontrolled bacterial, viral, fungal or parasite infection.&#xD;
&#xD;
          -  Under systemic treatment with corticosteroids or other immunosuppressive drugs in the&#xD;
             last 3 weeks before start of the trial treatment.&#xD;
&#xD;
          -  Participating in another clinical trial with pharmaceuticals in the last six weeks&#xD;
             before start of this trial treatment.&#xD;
&#xD;
          -  Not able to understand information.&#xD;
&#xD;
          -  Not willing or not able to give written consent to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Henning Arboe</last_name>
    <role>Study Chair</role>
    <affiliation>Meabco A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Russian Oncological Research Centre n.a. N.N. Blokhin, Russian Academy of Medical Science (RAMS)</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Petersburg State Budgetary Health Organization, City Clinical Oncology Dispensary</name>
      <address>
        <city>St Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leningrad Regional Oncological Centre</name>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siriraj Hospital, Mahidol University</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lampang Cancer Hospital</name>
      <address>
        <city>Lampang</city>
        <zip>52000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ubon Ratchanthani Cancer Hospital</name>
      <address>
        <city>Ubon Ratchathani</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Udon Thani Cancer Hospital</name>
      <address>
        <city>Udon Thani</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
    <country>Thailand</country>
  </location_countries>
  <results_reference>
    <citation>Larsen S, Butthongkomvong K, Manikhas A, Trishkina E, Poddubuskaya E, Matrosova M, Srimuninnimit V, Lindkaer-Jensen S. BP-C1 in the treatment of patients with stage IV breast cancer: a randomized, double-blind, placebo-controlled multicenter study and an additional open-label treatment phase. Breast Cancer (Dove Med Press). 2014 Nov 27;6:179-89. doi: 10.2147/BCTT.S71781. eCollection 2014. Erratum In: Breast Cancer (Dove Med Press). 2015;7:163.</citation>
    <PMID>25473312</PMID>
  </results_reference>
  <results_reference>
    <citation>Lindkaer-Jensen S, Larsen S, Habib-Lindkaer-Jensen N, Fagertun HE. Positive effects on hematological and biochemical imbalances in patients with metastatic breast cancer stage IV, of BP-C1, a new anticancer substance. Drug Des Devel Ther. 2015 Mar 13;9:1481-90. doi: 10.2147/DDDT.S80451. eCollection 2015.</citation>
    <PMID>25792808</PMID>
  </results_reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>October 8, 2019</last_update_submitted>
  <last_update_submitted_qc>October 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BP-C1</keyword>
  <keyword>Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin</keyword>
  <keyword>Benzene polycarboxylic acids complex with cis-diammineplatinum( II)</keyword>
  <keyword>Metastatic Breast Cancer</keyword>
  <keyword>Platinum analogue</keyword>
  <keyword>Metronomic chemotherapy</keyword>
  <keyword>Breast cancer</keyword>
  <keyword>Cisplatin</keyword>
  <keyword>cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from lignin</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>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/NCT03789019
org study id: BMC2011-02
nct id: NCT03789019
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to establish an optimal treatment duration and tolerable
      cumulative dose for BP-C1 in the treatment of metastatic breast cancer patients who had
      previously undergone at least three lines of chemotherapy.
BP-C1, solution for injection 0.05%, is currently being developed for treatment of patients
      with metastatic breast cancer with palliative intent. Active substance of the product, which
      is a novel platinum-containing anticancer agent developed for intramuscular administration,
      is cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids
      derived from lignin. The amphiphilic characteristics of the polymer have resulted in a
      product with clear and significantly altered and improved properties compared to other
      platinum analogues, e.g. cisplatin, carboplatin and oxaliplatin.

      BP-C1 preserves antitumour activity of its predecessors (e.g. cisplatin and carboplatin),
      additionally offering the following advantages that ensure favourable outcome of treatment of
      metastatic breast cancer patients:

        -  injectable solution (intramuscular) does not cause injection site reactions;

        -  can be administered at home by a nurse or a patient;

        -  has an improved pharmacokinetic profile;

        -  demonstrates efficacy comparable to cisplatin and much higher than carboplatin
           (in-vitro; in-vivo data);

        -  exerts an additional immunomodulatory activity.

      This study is an open-label, non-randomised, single-group, multi-centre study with a
      sequential safety design. The study consists of two parts: dose-response part and follow-up
      study.

      Dose-response part: Patients who have completed the first 32-day treatment period with BP-C1
      from Day 1 to Day 32 under Protocol BMC2011-1/Protocol MBC-BPC1/IIB or Protocol BMC2012-4,
      and having a maximum of "moderate" toxicity at the end of treatment are offered to continue
      in the second 32-day treatment period with BP-C1 from Day 33 to Day 64 under protocol
      BMC2011-02. Patients completing 64-day treatment period with BP-C1 will be followed up for 28
      days.

      Follow-up study: After 28-day follow-up period the patients without disease progression and
      without an increase in toxicity are offered to participate in the follow-up study. During the
      follow-up study the patients will be given BP-C1 as long as they obtain benefit from the
      treatment (i.e. until disease progression or increase in toxicity not above "moderate"
      grade).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Sum Common Toxicity Criteria score (Sum CTC score)
time frame: baseline to Day 64 of treatment period
description: Toxicity will be assessed according to National Cancer Institute Common Toxicity Criteria version 2.0 (CTC v2.0). The CTC v2.0 is divided in 15 toxicity categories (variables); each category is divided by corresponding sub-variables. Each sub-variable is measured on five-point fixed scale from 0 to 4: 0-none, 1-mild, 2-moderate, 3-severe, 4-life-threatening. However, in this trial each sub-variable will be measured on modified fixed scale from 1 to 4: 1-none or mild, 2-moderate, 3-severe, 4-life-threatening. The classification of each toxicity variable will be judged based on the largest observed value for its sub-variables. The Sum CTC score will be calculated by taking the sum of each variable across all categories.
measure: Maximum Common Toxicity Criteria score (Maximum CTC score)
time frame: baseline to Day 64 of treatment period
description: Toxicity will be assessed according to National Cancer Institute Common Toxicity Criteria version 2.0 (CTC v2.0). The CTC v2.0 is divided in 15 toxicity categories (variables); each category is divided by corresponding sub-variables. Each sub-variable is measured on five-point fixed scale from 0 to 4: 0-none, 1-mild, 2-moderate, 3-severe, 4-life-threatening. However, in this trial each sub-variable will be measured on modified fixed scale from 1 to 4: 1-none or mild, 2-moderate, 3-severe, 4-life-threatening. The classification of each toxicity variable will be judged based on the largest observed value for its sub-variables. The Maximum CTC score will be calculated by taking the maximum value among all variables across all categories.
measure: Change (%) in the sum of diameters of target lesions
time frame: baseline to Day 64 of treatment period
description: Diameter of target lesions will be measured by computer tomography (CT) with contrasting using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
measure: Treatment response
time frame: baseline to Day 64 of treatment period
description: In accordance with RECIST v1.1 the treatment response will be classified as 'complete response', 'partial response', 'stable disease' or 'progressive disease': Complete response (CR): disappearance of all target lesions. Partial response (PR): at least 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum of diameters. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum might also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions will also be considered progression. Stable disease (SD): neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
measure: Karnofsky Performance Status score (KPS score)
time frame: baseline to Day 64 of treatment period
description: KPS score will give an outcome with 11 grades, starting as normal status without complaints and evidence of disease as the best (KPS score = 100) and the dead status as the lowest (KPS score = 0)
measure: Changes in sub-scores of the three major scales of general quality of life questionnaire (EORTC QLQ-C30)
time frame: baseline to Day 64 of treatment period
description: Quality of life sub-scores will be obtained by general cancer questionnaire EORTC QLQ-C30. EORTC QLQ-C30 consists of 30 questions generally related to cancer. The questionnaire will be self-administered and will be given in patient's mother tongue. EORTC QLQ-C30 (version 3) is divided in the 3 major scales that will be presented as 15 sub-scores: i) global health status; ii) functional scale (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning); iii) symptom scale/item(fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties). Range of functional scale is 0-100 (high values are "better"). Range of symptom scale is 0-100 (low values are "better").
measure: Changes in sub-scores of the specific quality of life questionnaire (EORTC QLQ-BR23)
time frame: baseline to Day 64 of treatment period
description: Quality of life sub-scores will be obtained by specific breast cancer questionnaire EORTC QLQ-BR23. EORTC QLQ-BR-23 consists of 23 questions related to breast cancer. The questionnaire will be self-administered and will be given in patient's mother tongue. EORTC QLQ-BR23 is divided in 2 scales that will be presented as 8 sub-scores: i) functional scale (body image, sexual functioning, sexual enjoyment, future perspective); ii) symptom scale/item (systemic therapy side effect, breast symptom, arm symptom, upset by hair loss). Range of functional scale is 0-100 (high values are "better"). Range of symptom scale is 0-100 (low values are "better").
measure: Number of registered adverse events
time frame: baseline to Day 28 of follow-up period
description: Adverse events (AEs) will be coded according to the MedDRA (version 16.1E). AEs will be systemized by system organ class and by preferred term. AEs will be analyzed by severity, seriousness and relatedness to the drug.
arm group label: BP-C1
arm group type: Experimental
description: Dose-response part: patients who have completed the first 32-day treatment period with BP-C1 under Protocol BMC2011-1/Protocol MBC-BPC1/IIB or Protocol BMC2012-4, and having a maximum of "moderate" toxicity at the end of treatment are offered to continue in the second 32-day treatment period with BP-C1 under the protocol BMC2011-02. Patients completing 64-day treatment period with BP-C1 will be followed up for 28 days.
Follow-up study: the patients will be given BP-C1 as long as they obtain benefit from the treatment (i.e. until disease progression or increase in toxicity not above "moderate" grade).
intervention type: Drug
intervention name: BP-C1
description: BP-C1, 0.05% solution for injection; doses: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days
arm group label: BP-C1
other name: Cis-coordinated complexes of platinum(II) with polymer of benzene polycarboxylic acids derived from lignin
other name: Cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from lignin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Henning Arboe
role: Study Chair
affiliation: Meabco A/S
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country: Russian Federation
country: Thailand
citation: Larsen S, Butthongkomvong K, Manikhas A, Trishkina E, Poddubuskaya E, Matrosova M, Srimuninnimit V, Lindkaer-Jensen S. BP-C1 in the treatment of patients with stage IV breast cancer: a randomized, double-blind, placebo-controlled multicenter study and an additional open-label treatment phase. Breast Cancer (Dove Med Press). 2014 Nov 27;6:179-89. doi: 10.2147/BCTT.S71781. eCollection 2014. Erratum In: Breast Cancer (Dove Med Press). 2015;7:163.
PMID: 25473312
citation: Lindkaer-Jensen S, Larsen S, Habib-Lindkaer-Jensen N, Fagertun HE. Positive effects on hematological and biochemical imbalances in patients with metastatic breast cancer stage IV, of BP-C1, a new anticancer substance. Drug Des Devel Ther. 2015 Mar 13;9:1481-90. doi: 10.2147/DDDT.S80451. eCollection 2015.
PMID: 25792808
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No