<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/NCT01695226</url>
  </required_header>
  <id_info>
    <org_study_id>MUMC MEC 04-038</org_study_id>
    <nct_id>NCT01695226</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer</brief_title>
  <official_title>Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cyclooxygenase-2 (COX-2) is frequently over-expressed in primary breast cancer. There is&#xD;
      evidence that COX-2 inhibition exerts anti-tumor effects in breast cancer. To further&#xD;
      determine the effect of COX-2 inhibition in primary breast cancer, we aimed at studying the&#xD;
      changes in breast cancer tissues of patients treated with the selective COX-2 inhibitor&#xD;
      celecoxib.&#xD;
&#xD;
      In a single-centre double-blinded phase II study, breast cancer patients were randomised to&#xD;
      receive either pre-operative celecoxib (400 mg) or placebo twice daily for two to three&#xD;
      weeks. We collected fresh-frozen pre-surgical biopsies (before treatment) and surgical&#xD;
      excision specimens (after treatment) to assess the tumor changes by use a cDNA microarray,&#xD;
      which allows to study the genome-wide changes at the transcriptional level.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2004</start_date>
  <primary_completion_date type="Actual">July 2007</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>whole-genome expression after celecoxib treatment</measure>
    <description>Affymetrix arrays were performed on pre- and post treated (celecoxib and placebo) breast cancer tissues</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent change of Ki-67 protein positivity in celecoxib-treated breast cancer tissues versus placebo-treated tissues</measure>
  </secondary_outcome>
  <other_outcome>
    <measure>Measurement of protein expression of CD34 and CASP3 in post-treated (celecoxib and placebo) breast cancer tissues</measure>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <condition>Breast Neoplasms</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>pre-operative placebo twice daily for two to three weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>celecoxib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>pre-operative celecoxib (400 mg) twice daily for two to three weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>celecoxib</intervention_name>
    <description>pre-operative celecoxib (400 mg) twice daily for two to three weeks</description>
    <arm_group_label>celecoxib</arm_group_label>
    <other_name>celebrex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>pre-operative placebo twice daily for two to three weeks</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients suspected of having invasive breast cancer, &gt;1 cm in diameter, and in&#xD;
             whom there is an indication for a core or incision biopsy&#xD;
&#xD;
          -  Age &lt;75 years at time of diagnosis&#xD;
&#xD;
          -  Patient willing and able to comply with the study prescriptions&#xD;
&#xD;
          -  Patient able to give written informed consent before patient&#xD;
             registration/randomisation&#xD;
&#xD;
          -  Pre- and post-menopausal patients are eligible&#xD;
&#xD;
          -  Hormone receptor positive and negative patients are eligible&#xD;
&#xD;
          -  A negative pregnancy test in pre-menopausal women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HIV, HBV or HCV positivity&#xD;
&#xD;
          -  Known hypersensitivity to NSAIDs&#xD;
&#xD;
          -  A history of upper gastro-intestinal bleeding&#xD;
&#xD;
          -  Endoscopically proven upper gastro-intestinal ulceration&#xD;
&#xD;
          -  Patients using NSAIDs, including salicyclic acid&#xD;
&#xD;
          -  Systemic use of corticosteroids&#xD;
&#xD;
          -  A history or the presence of any other malignancy excepting adequately treated&#xD;
             squamous cell skin cancer or in situ carcinoma of the cervix&#xD;
&#xD;
          -  Patients who have been treated with neo-adjuvant chemotherapy or hormone therapy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre SJ Hupperets, MD; PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Maastricht</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <results_reference>
    <citation>Brandao RD, Veeck J, Van de Vijver KK, Lindsey P, de Vries B, van Elssen CH, Blok MJ, Keymeulen K, Ayoubi T, Smeets HJ, Tjan-Heijnen VC, Hupperets PS. A randomised controlled phase II trial of pre-operative celecoxib treatment reveals anti-tumour transcriptional response in primary breast cancer. Breast Cancer Res. 2013 Apr 8;15(2):R29. doi: 10.1186/bcr3409.</citation>
    <PMID>23566419</PMID>
  </results_reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>January 5, 2018</last_update_submitted>
  <last_update_submitted_qc>January 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Celecoxib</keyword>
  <keyword>Clinical trial, Phase II</keyword>
  <keyword>Oligonucleotide Array Sequence Analysis</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>Celecoxib</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/NCT01695226
org study id: MUMC MEC 04-038
nct id: NCT01695226
lead sponsor: 
has dmc: No
Cyclooxygenase-2 (COX-2) is frequently over-expressed in primary breast cancer. There is
      evidence that COX-2 inhibition exerts anti-tumor effects in breast cancer. To further
      determine the effect of COX-2 inhibition in primary breast cancer, we aimed at studying the
      changes in breast cancer tissues of patients treated with the selective COX-2 inhibitor
      celecoxib.

      In a single-centre double-blinded phase II study, breast cancer patients were randomised to
      receive either pre-operative celecoxib (400 mg) or placebo twice daily for two to three
      weeks. We collected fresh-frozen pre-surgical biopsies (before treatment) and surgical
      excision specimens (after treatment) to assess the tumor changes by use a cDNA microarray,
      which allows to study the genome-wide changes at the transcriptional level.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: whole-genome expression after celecoxib treatment
description: Affymetrix arrays were performed on pre- and post treated (celecoxib and placebo) breast cancer tissues
measure: Percent change of Ki-67 protein positivity in celecoxib-treated breast cancer tissues versus placebo-treated tissues
measure: Measurement of protein expression of CD34 and CASP3 in post-treated (celecoxib and placebo) breast cancer tissues
arm group label: placebo
arm group type: Placebo Comparator
description: pre-operative placebo twice daily for two to three weeks
arm group label: celecoxib
arm group type: Experimental
description: pre-operative celecoxib (400 mg) twice daily for two to three weeks
intervention type: Drug
intervention name: celecoxib
description: pre-operative celecoxib (400 mg) twice daily for two to three weeks
arm group label: celecoxib
other name: celebrex
intervention type: Drug
intervention name: Placebo
description: pre-operative placebo twice daily for two to three weeks
arm group label: placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 74 Years
healthy volunteers: No
last name: Pierre SJ Hupperets, MD; PhD
role: Principal Investigator
affiliation: Maastricht University Medical Centre
facility: 
country: Netherlands
citation: Brandao RD, Veeck J, Van de Vijver KK, Lindsey P, de Vries B, van Elssen CH, Blok MJ, Keymeulen K, Ayoubi T, Smeets HJ, Tjan-Heijnen VC, Hupperets PS. A randomised controlled phase II trial of pre-operative celecoxib treatment reveals anti-tumour transcriptional response in primary breast cancer. Breast Cancer Res. 2013 Apr 8;15(2):R29. doi: 10.1186/bcr3409.
PMID: 23566419
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Celecoxib