<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/NCT01671319</url>
  </required_header>
  <id_info>
    <org_study_id>CO10104</org_study_id>
    <secondary_id>2011-0062</secondary_id>
    <secondary_id>NCI-2011-03640</secondary_id>
    <secondary_id>A535900</secondary_id>
    <secondary_id>SMPH\ONCOLOGY\ONCOLOGY</secondary_id>
    <nct_id>NCT01671319</nct_id>
  </id_info>
  <brief_title>Dose Dense TC + Pegfilgrastim Support for Breast Cancer</brief_title>
  <acronym>ddTC</acronym>
  <official_title>Phase II Study of Dose-Dense TC (Docetaxel + Cyclophosphamide) With Pegfilgrastim Support for Adjuvant Therapy of pN0, pN1 or Nx Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the feasibility of giving standard TC chemotherapy&#xD;
      on a dose dense schedule (ddTC) as well as evaluating the nature and frequency of ddTC side&#xD;
      effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A standard chemotherapy treatment option for breast cancer after surgery (adjuvant therapy)&#xD;
      is docetaxel + cyclophosphamide (TC). This study looks at a different schedule for giving the&#xD;
      same adjuvant chemotherapy so that treatment can be completed faster (in 8 weeks rather than&#xD;
      12 weeks). This study uses a growth factor drug, pegfilgrastim, to help build blood cells&#xD;
      that are lowered because of chemotherapy, making it possible to receive TC treatment every 2&#xD;
      weeks (referred to as &quot;dose dense TC&quot; or &quot;ddTC&quot;) instead of the standard 3 week schedule. The&#xD;
      main study procedures are blood draws, chemotherapy treatment, physical exams, and&#xD;
      pegfilgrastim injections.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</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>Feasibility for Dose-dense TC Therapy: Number of Participants Receiving at Least 90% of Total Dose of Therapy</measure>
    <time_frame>4 cycles each 2 weeks in length for a total of 8 weeks, up to 10 weeks</time_frame>
    <description>Evaluate feasibility of delivering 4 cycles (1 cycle = 2 weeks) of docetaxel and cyclophosphamide (TC) on a dose-dense (q2week) schedule with pegfilgrastim support. This regimen will be referred to as dose-dense (dd)TC. Feasibility defined by at least 60% of patients receiving 90% of the total dose of therapy within 10 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Febrile Neutropenia</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>Neutropenic fever was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Neuropathy</measure>
    <time_frame>Up to 10 weeks</time_frame>
    <description>Neuropathy was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Female Breast Cancer</condition>
  <arm_group>
    <arm_group_label>dose dense TC + pegfilgrastim</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>docetaxel + cyclophosphamide + pegfilgrastim</intervention_name>
    <description>docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle</description>
    <arm_group_label>dose dense TC + pegfilgrastim</arm_group_label>
    <other_name>Taxotere, Cytoxan, Neulasta</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  histologically confirmed invasive carcinoma of the female breast, status post&#xD;
             definitive surgery (lumpectomy or mastectomy plus nodal evaluation if feasible).&#xD;
             Patients must initiate therapy with ddTC within 84 days of the last breast or axillary&#xD;
             surgery performed for curative intent&#xD;
&#xD;
          -  candidate for chemotherapy by the treating oncologist&#xD;
&#xD;
          -  Patients with pN2 or pN3 disease are NOT explicitly excluded. However, patients with&#xD;
             N2 or N3 disease MUST be reviewed with the PI or study chair before being enrolled on&#xD;
             the study as TC would not normally be considered adequate therapy for such patients.&#xD;
&#xD;
          -  Patients with bilateral, synchronous invasive breast cancer are eligible as long as&#xD;
             both primary tumors meet the eligibility criteria.&#xD;
&#xD;
          -  Patients with estrogen-receptor (ER) and/or progesterone receptor (PR) negative,&#xD;
             positive, or unknown tumors are eligible.&#xD;
&#xD;
          -  Patients with HER2 positive, negative or unknown disease are eligible for this trial.&#xD;
             Patients whose tumors are HER2 positive by either immunohistochemistry (IHC) 3+&#xD;
             staining or demonstrate gene amplification by FISH should receive trastuzumab,&#xD;
             following completion of adjuvant cytotoxic therapy with 4 cycles of ddTC.&#xD;
&#xD;
          -  There must be negative surgical margins for invasive cancer and DCIS. LCIS is&#xD;
             acceptable at the margin.&#xD;
&#xD;
          -  Patients with multi-centric breast cancer are eligible as long as all known disease is&#xD;
             resected from the breast with negative margins.&#xD;
&#xD;
          -  Age &gt;18 years.&#xD;
&#xD;
          -  ECOG performance status ≤ 1&#xD;
&#xD;
          -  Women of childbearing potential should have a negative urine or blood beta-HCG, and&#xD;
             must agree to contraception if engaging in sexual activity. Should a woman become&#xD;
             pregnant or suspect she is pregnant while participating in this study, she should&#xD;
             inform her treating physician immediately. Women must not be pregnant or nursing as&#xD;
             the chemotherapy drugs used in this study may cause harm to a fetus or newborn.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
          -  Platelets &gt;/=100,000/μl within 4 weeks of registration.&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;/= 1,500/μl within 4 weeks of registration.&#xD;
&#xD;
          -  Total bilirubin within normal institutional limits within 4 weeks of registration.&#xD;
&#xD;
          -  Alkaline phosphatase (alk phos) ≤ 2.5 X institutional Upper Limit of Normal (ULN)&#xD;
             within 4 weeks of registration.&#xD;
&#xD;
          -  AST (SGOT)/ALT(SGPT) ≤ 1.5X ULN&#xD;
&#xD;
          -  Creatinine within normal institutional limits OR Creatinine clearance&gt;/= 60&#xD;
             mL/min/1.73 m2 for patients with creatinine levels above normal&#xD;
&#xD;
          -  If patient has received tamoxifen or another selective estrogen receptor modulator&#xD;
             (SERM) for prevention or for other indications (not for treatment of this cancer),&#xD;
             they have been discontinued prior to enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has received previous trastuzumab, chemotherapy, hormonal therapy, or other&#xD;
             anti-cancer agents (including investigational agents) for this malignancy.&#xD;
&#xD;
          -  Patient will be receiving GNRH agonists such as goserelin (Zoladex) or leuprolide&#xD;
             acetate (Lupron) concomitantly with chemotherapy for the purpose of preventing breast&#xD;
             cancer recurrence.&#xD;
&#xD;
          -  Patient has inflammatory breast cancer (pT4d) or metastatic breast cancer.&#xD;
&#xD;
          -  Patient has uncontrolled intercurrent illness including, but not limited to, ongoing&#xD;
             or active infection, symptomatic congestive heart failure, unstable angina pectoris,&#xD;
             cardiac arrhythmia or psychiatric illness/social situations that would limit&#xD;
             compliance with study requirements.&#xD;
&#xD;
          -  Patient has pre-existing persistent neuropathy.&#xD;
&#xD;
          -  The patient has received prior chemotherapy or radiotherapy or any malignancy within&#xD;
             the past 2 years.&#xD;
&#xD;
          -  Patient has received prior docetaxel or cyclophosphamide within the past 5 years.&#xD;
&#xD;
          -  Patient has known contraindication or hypersensitivity to docetaxel, cyclophosphamide&#xD;
             or pegfilgrastim.&#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>Amye J Tevaarwerk, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://cancer.wisc.edu/</url>
    <description>University of Wisconsin Carbone Cancer Center</description>
  </link>
  <results_reference>
    <citation>Burkard ME, Wisinski KB, Njiaju UO, Donohue S, Hegeman R, Stella A, Mansky P, Shah V, Goggins T, Qamar R, Dietrich L, Kim K, Traynor AM, Tevaarwerk AJ. Feasibility of 4 cycles of docetaxel and cyclophosphamide every 14 days as an adjuvant regimen for breast cancer: a Wisconsin Oncology Network study. Clin Breast Cancer. 2014 Jun;14(3):205-11. doi: 10.1016/j.clbc.2013.10.018. Epub 2013 Oct 26.</citation>
    <PMID>24342730</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 5, 2011</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <results_first_submitted>June 12, 2017</results_first_submitted>
  <results_first_submitted_qc>September 11, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 12, 2017</results_first_posted>
  <last_update_submitted>November 14, 2019</last_update_submitted>
  <last_update_submitted_qc>November 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>female</keyword>
  <keyword>women</keyword>
  <keyword>adjuvant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was performed through the Wisconsin Oncology Network, a regional oncology network, at a combination of academic and community practice sites. Patients were enrolled between June 2011 and June 2012.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Dose Dense TC + Pegfilgrastim</title>
          <description>Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle&#xD;
docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Women with early stage breast cancer.</population>
      <group_list>
        <group group_id="B1">
          <title>Dose Dense TC + Pegfilgrastim</title>
          <description>Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle&#xD;
docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="41"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54" lower_limit="28" upper_limit="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre- vs. Postmenopausal</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Premenopausal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postmenopausal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Staging Criteria</title>
          <description>Participants were staged according to the American Joint Committee on Cancer (AJCC) staging manual.&#xD;
Node-negative: cancer has not spread to the lymph nodes Node-positive: cancer that has spread to the lymph nodes T1 and T2 refer to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Node-negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Node-positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nodes unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Receptor Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hormone receptor-postive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HER2-positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triple negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Final Surgery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Mastectomy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breast conservation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Feasibility for Dose-dense TC Therapy: Number of Participants Receiving at Least 90% of Total Dose of Therapy</title>
        <description>Evaluate feasibility of delivering 4 cycles (1 cycle = 2 weeks) of docetaxel and cyclophosphamide (TC) on a dose-dense (q2week) schedule with pegfilgrastim support. This regimen will be referred to as dose-dense (dd)TC. Feasibility defined by at least 60% of patients receiving 90% of the total dose of therapy within 10 weeks.</description>
        <time_frame>4 cycles each 2 weeks in length for a total of 8 weeks, up to 10 weeks</time_frame>
        <population>Of 42 participants, 41 were evaluable for outcome measure analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Dense TC + Pegfilgrastim</title>
            <description>Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle&#xD;
docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility for Dose-dense TC Therapy: Number of Participants Receiving at Least 90% of Total Dose of Therapy</title>
          <description>Evaluate feasibility of delivering 4 cycles (1 cycle = 2 weeks) of docetaxel and cyclophosphamide (TC) on a dose-dense (q2week) schedule with pegfilgrastim support. This regimen will be referred to as dose-dense (dd)TC. Feasibility defined by at least 60% of patients receiving 90% of the total dose of therapy within 10 weeks.</description>
          <population>Of 42 participants, 41 were evaluable for outcome measure analysis.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Febrile Neutropenia</title>
        <description>Neutropenic fever was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy.</description>
        <time_frame>Up to 10 weeks</time_frame>
        <population>Of 42 participants, 41 were evaluable for outcome measure analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Dense TC + Pegfilgrastim</title>
            <description>Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle&#xD;
docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Febrile Neutropenia</title>
          <description>Neutropenic fever was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy.</description>
          <population>Of 42 participants, 41 were evaluable for outcome measure analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Neuropathy</title>
        <description>Neuropathy was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy.</description>
        <time_frame>Up to 10 weeks</time_frame>
        <population>Of 42 participants, 41 were evaluable for outcome measure analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Dense TC + Pegfilgrastim</title>
            <description>Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle&#xD;
docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Neuropathy</title>
          <description>Neuropathy was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy.</description>
          <population>Of 42 participants, 41 were evaluable for outcome measure analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Sensory neuropathy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Motor neuropathy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No incidence of neuropathy</title>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Toxicity assessments were made one day 1 of each cycle, and as indicated clinically.</desc>
      <group_list>
        <group group_id="E1">
          <title>Dose Dense TC + Pegfilgrastim</title>
          <description>Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle&#xD;
docetaxel + cyclophosphamide + pegfilgrastim: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Perforation, GI</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash/desquamation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hemoglobin</sub_title>
                <counts group_id="E1" events="59" subjects_affected="32" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hemorrhage, pulmonary/upper respiratory - Nose</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hemorrhage/Bleeding</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Leukocytes (total WBC)</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Neutrophils/granulocytes (ANC/AGC)</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Platelets</sub_title>
                <counts group_id="E1" events="15" subjects_affected="11" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Supraventricular and nodal arrhythmia - Sinus bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Supraventricular and nodal arrhythmia - Sinus tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Auditory/Ear - Ear pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Edema: limb</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hot flashes/flushes</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dry eye syndrome</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Ocular/Visual - Itchy eyes</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Vision-blurred vision</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Watery eye (epiphora, tearing)</sub_title>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="21" subjects_affected="14" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Distension/bloating, abdominal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Dry mouth/salivary gland (xerostomia)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Gastritis (including bile reflux gastritis)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Gastrointestinal</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Heartburn/dyspepsia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Mucositis/stomatitis (clinical exam) - Oral cavity</sub_title>
                <counts group_id="E1" events="21" subjects_affected="17" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="29" subjects_affected="18" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Perforation, GI - Colon</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Taste alteration (dysgeusia)</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue (asthenia, lethargy, malaise)</sub_title>
                <counts group_id="E1" events="71" subjects_affected="34" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hypothermia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Injection site reaction/extravasation changes</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="77" subjects_affected="33" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Sweating (diaphoresis)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Weight gain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic reaction/hypersensitivity (including drug fever)</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Autoimmune reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Cytokine release syndrome/acute infusion reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Albumin, serum-low (hypoalbuminemia)</sub_title>
                <counts group_id="E1" events="11" subjects_affected="6" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>ALT, SGPT (serum glutamic pyruvic transaminase)</sub_title>
                <counts group_id="E1" events="20" subjects_affected="16" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>AST, SGOT(serum glutamic oxaloacetic transaminase)</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Bilirubin (hyperbilirubinemia)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Calcium, serum-high (hypercalcemia)</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Calcium, serum-low (hypocalcemia)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Creatinine</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Glucose, serum-high (hyperglycemia)</sub_title>
                <counts group_id="E1" events="32" subjects_affected="14" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Phosphate, serum-low (hypophosphatemia)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Potassium, serum-low (hypokalemia)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Sodium, serum-low (hyponatremia)</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis (non-septic)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Mood alteration - Anxiety</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Neurology - Other</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Neuropathy: motor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Neuropathy: sensory</sub_title>
                <counts group_id="E1" events="30" subjects_affected="22" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal/Genitourinary - Dysuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Urinary frequency/urgency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Irregular menses (change from baseline)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Vaginal mucositis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Dyspnea (shortness of breath)</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Nasal cavity/paranasal sinus reactions</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Pulmonary/Upper Respiratory - Other</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bruising (in absence of Grade 3 or 4 thrombocytopenia)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Dermatology/Skin</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Hair loss/alopecia (scalp or body)</sub_title>
                <counts group_id="E1" events="26" subjects_affected="21" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Nail changes</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Photosensitivity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Rash/desquamation</sub_title>
                <counts group_id="E1" events="14" subjects_affected="8" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Rash: acne/acneiform</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Rash: hand-foot skin reaction</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Wound complication, non-infectious</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Phlebitis (including superficial thrombosis)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Amyé Tevaarwerk</name_or_title>
      <organization>University of Wisconsin Carbone Cancer Center</organization>
      <phone>608-262-2837</phone>
      <email>at4@medicine.wisc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01671319
org study id: CO10104
secondary id: 2011-0062
secondary id: NCI-2011-03640
secondary id: A535900
secondary id: SMPH\ONCOLOGY\ONCOLOGY
nct id: NCT01671319
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine the feasibility of giving standard TC chemotherapy
      on a dose dense schedule (ddTC) as well as evaluating the nature and frequency of ddTC side
      effects.
A standard chemotherapy treatment option for breast cancer after surgery (adjuvant therapy)
      is docetaxel + cyclophosphamide (TC). This study looks at a different schedule for giving the
      same adjuvant chemotherapy so that treatment can be completed faster (in 8 weeks rather than
      12 weeks). This study uses a growth factor drug, pegfilgrastim, to help build blood cells
      that are lowered because of chemotherapy, making it possible to receive TC treatment every 2
      weeks (referred to as "dose dense TC" or "ddTC") instead of the standard 3 week schedule. The
      main study procedures are blood draws, chemotherapy treatment, physical exams, and
      pegfilgrastim injections.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility for Dose-dense TC Therapy: Number of Participants Receiving at Least 90% of Total Dose of Therapy
time frame: 4 cycles each 2 weeks in length for a total of 8 weeks, up to 10 weeks
description: Evaluate feasibility of delivering 4 cycles (1 cycle = 2 weeks) of docetaxel and cyclophosphamide (TC) on a dose-dense (q2week) schedule with pegfilgrastim support. This regimen will be referred to as dose-dense (dd)TC. Feasibility defined by at least 60% of patients receiving 90% of the total dose of therapy within 10 weeks.
measure: Incidence of Febrile Neutropenia
time frame: Up to 10 weeks
description: Neutropenic fever was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy.
measure: Incidence of Neuropathy
time frame: Up to 10 weeks
description: Neuropathy was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy.
arm group label: dose dense TC + pegfilgrastim
arm group type: Experimental
description: Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle
intervention type: Drug
intervention name: docetaxel + cyclophosphamide + pegfilgrastim
description: docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle
arm group label: dose dense TC + pegfilgrastim
other name: Taxotere, Cytoxan, Neulasta
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amye J Tevaarwerk, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
url: https://cancer.wisc.edu/
description: University of Wisconsin Carbone Cancer Center
citation: Burkard ME, Wisinski KB, Njiaju UO, Donohue S, Hegeman R, Stella A, Mansky P, Shah V, Goggins T, Qamar R, Dietrich L, Kim K, Traynor AM, Tevaarwerk AJ. Feasibility of 4 cycles of docetaxel and cyclophosphamide every 14 days as an adjuvant regimen for breast cancer: a Wisconsin Oncology Network study. Clin Breast Cancer. 2014 Jun;14(3):205-11. doi: 10.1016/j.clbc.2013.10.018. Epub 2013 Oct 26.
PMID: 24342730
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Cyclophosphamide
mesh term: Docetaxel
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 