<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/NCT01674842</url>
  </required_header>
  <id_info>
    <org_study_id>12-283</org_study_id>
    <nct_id>NCT01674842</nct_id>
  </id_info>
  <brief_title>Cisplatin + RT for Triple Negative Breast Cancer</brief_title>
  <official_title>A Phase I Dose-Escalation Study of Cisplatin and Radiation Therapy for Patients With Triple Negative Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dana-Farber Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase I dose escalation study of cisplatin and concurrent radiation in patients&#xD;
      with ER negative, PR negative and HER2 negative breast cancer who have undergone&#xD;
      breast-conserving surgery or mastectomy.&#xD;
&#xD;
      Primary objective: To assess the safety, tolerability, and maximum tolerated dose (MTD) of&#xD;
      cisplatin when given concurrently with radiation therapy for participants with Stage II or&#xD;
      III breast cancer who have undergone breast conserving surgery or mastectomy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase I dose escalation study of cisplatin and radiation to determine the toxicity&#xD;
      of this combined treatment and establish an MTD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 8, 2021</completion_date>
  <primary_completion_date type="Actual">August 2018</primary_completion_date>
  <phase>Phase 1</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>Safety of Cisplatin w/ Radiation</measure>
    <time_frame>2 years</time_frame>
    <description>To determine the maximum tolerated dose of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Local recurrence at 5 years</measure>
    <time_frame>5 years</time_frame>
    <description>To assess local recurrence at 5-years in participants receiving cisplatin concurrently with radiation, as compared with historic controls receiving radiation without concurrent chemotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term toxicity</measure>
    <time_frame>2 years</time_frame>
    <description>To assess long-term toxicity in participants receiving cisplatin concurrently with radiation</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Cisplatin + Radiation Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cisplatin concurrently with radiation therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation Therapy</intervention_name>
    <description>Once daily, Monday - Friday for six weeks</description>
    <arm_group_label>Cisplatin + Radiation Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Intravenously, once weekly for six weeks</description>
    <arm_group_label>Cisplatin + Radiation Therapy</arm_group_label>
    <other_name>CDDP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary tumor is triple negative breast cancer&#xD;
&#xD;
          -  Breast-conserving surgery or mastectomy with surgical excision of all gross disease&#xD;
             with negative surgical margins&#xD;
&#xD;
          -  Pathologic or clinical stage II or III disease&#xD;
&#xD;
          -  At least 3 week interval from last chemotherapy administration/breast surgery to&#xD;
             radiation (no more than 8 weeks)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Prior radiation to breast or ipsilateral regional nodes&#xD;
&#xD;
          -  Ongoing therapy with other investigational agents&#xD;
&#xD;
          -  Hormonal therapy&#xD;
&#xD;
          -  Significant co-morbidity&#xD;
&#xD;
          -  Pathologic complete response following preoperative chemotherapy&#xD;
&#xD;
          -  Biopsy proven metastatic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer R Bellon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber at Milford</name>
      <address>
        <city>Milford</city>
        <state>Massachusetts</state>
        <zip>01757</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber at South Shore Hospital</name>
      <address>
        <city>Weymouth</city>
        <state>Massachusetts</state>
        <zip>02190</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>August 23, 2021</last_update_submitted>
  <last_update_submitted_qc>August 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Jennifer Bellon</investigator_full_name>
    <investigator_title>Principal Invstigator</investigator_title>
  </responsible_party>
  <keyword>Triple negative</keyword>
  <keyword>Stage II</keyword>
  <keyword>Stage III</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
  </intervention_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/NCT01674842
org study id: 12-283
nct id: NCT01674842
lead sponsor: 
has dmc: Yes
This is a Phase I dose escalation study of cisplatin and concurrent radiation in patients
      with ER negative, PR negative and HER2 negative breast cancer who have undergone
      breast-conserving surgery or mastectomy.

      Primary objective: To assess the safety, tolerability, and maximum tolerated dose (MTD) of
      cisplatin when given concurrently with radiation therapy for participants with Stage II or
      III breast cancer who have undergone breast conserving surgery or mastectomy
This is a phase I dose escalation study of cisplatin and radiation to determine the toxicity
      of this combined treatment and establish an MTD.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety of Cisplatin w/ Radiation
time frame: 2 years
description: To determine the maximum tolerated dose of cisplatin when given concurrently with radiation therapy for participants with Stage II or III breast cancer who have undergone breast conserving surgery or mastectomy.
measure: Local recurrence at 5 years
time frame: 5 years
description: To assess local recurrence at 5-years in participants receiving cisplatin concurrently with radiation, as compared with historic controls receiving radiation without concurrent chemotherapy.
measure: Long term toxicity
time frame: 2 years
description: To assess long-term toxicity in participants receiving cisplatin concurrently with radiation
arm group label: Cisplatin + Radiation Therapy
arm group type: Experimental
description: Cisplatin concurrently with radiation therapy
intervention type: Radiation
intervention name: Radiation Therapy
description: Once daily, Monday - Friday for six weeks
arm group label: Cisplatin + Radiation Therapy
intervention type: Drug
intervention name: Cisplatin
description: Intravenously, once weekly for six weeks
arm group label: Cisplatin + Radiation Therapy
other name: CDDP
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer R Bellon, MD
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Jennifer Bellon
investigator title: Principal Invstigator
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms
mesh term: Cisplatin