<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/NCT02979301</url>
  </required_header>
  <id_info>
    <org_study_id>IRB 16-008736</org_study_id>
    <nct_id>NCT02979301</nct_id>
  </id_info>
  <brief_title>Impact of Low-dose Tamoxifen on BPU</brief_title>
  <official_title>Low-Dose Tamoxifen to Reduce High Background Parenchymal Uptake on Molecular Breast Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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 study will examine whether changes in background parenchymal uptake (BPU) on molecular&#xD;
      breast imaging (MBI) can be induced by short-term use of low-dose tamoxifen. Women who have&#xD;
      previously had high BPU on MBI will be recruited. Participants will take low-dose tamoxifen&#xD;
      for a 30-day period, with post-tamoxifen MBI in order to investigate the impact of tamoxifen&#xD;
      on BPU.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">November 1, 2018</completion_date>
  <primary_completion_date type="Actual">February 25, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Background Parenchymal Uptake (BPU) on Molecular Breast Imaging (MBI)</measure>
    <time_frame>30 days</time_frame>
    <description>An image analysis tool to obtain a quantitative measure of background parenchymal uptake (BPU) was applied to pre-tamoxifen and post-tamoxifen MBI exams. The percent change in BPU from pre-tamoxifen to post-tamoxifen MBI was determined.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>High Background Uptake on MBI</condition>
  <arm_group>
    <arm_group_label>Tamoxifen 5 mg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women with high background uptake on MBI take 5 mg tam per day for 30 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tamoxifen 10 mg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women with high background uptake on MBI take 10 mg tam per day for 30 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamoxifen</intervention_name>
    <description>5 mg or 10 mg tamoxifen per day for 30 days.</description>
    <arm_group_label>Tamoxifen 10 mg/day</arm_group_label>
    <arm_group_label>Tamoxifen 5 mg/day</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:The following are requirements for entry into the study:&#xD;
&#xD;
          1. Female, age 40 or older at the time of enrollment&#xD;
&#xD;
          2. Most recent MBI examination, performed within 3 years of enrollment, showed moderate&#xD;
             or marked background parenchymal uptake&#xD;
&#xD;
          3. Mammogram performed within 12 months prior to enrollment that is available for&#xD;
             comparison&#xD;
&#xD;
          4. Willing and able to return for MBI following 30 days of low-dose tamoxifen&#xD;
&#xD;
          5. If able to become pregnant&#xD;
&#xD;
               1. Negative pregnancy test within 48 hours prior to study MBI exam(s)&#xD;
&#xD;
               2. Agrees to avoid pregnancy during the study and for at least 2 months after study&#xD;
                  participation ends, by abstinence, barrier method, or nonhormonal contraception.&#xD;
&#xD;
          6. Understands and signs the consent form&#xD;
&#xD;
             -&#xD;
&#xD;
        Exclusion Criteria:Subjects will be excluded if any of the following characteristics are&#xD;
        present:&#xD;
&#xD;
        1) Evidence of suspected breast disease as defined by positive findings or recommendation&#xD;
        for short-interval follow-up on most recent breast imaging (including mammography, MBI,&#xD;
        MRI, ultrasound, etc.) not yet resolved prior to enrollment 2) Breast biopsy or breast&#xD;
        surgery performed 6 months prior to enrollment 3) Bilateral breast implants or status&#xD;
        post-bilateral prophylactic mastectomy 4) Pregnant or lactating 5) Current or recent use&#xD;
        (within 6 months prior to enrollment) of any of the following drugs:&#xD;
&#xD;
          1. Systemic hormonal therapy (oral or transdermal patch formulations)&#xD;
&#xD;
          2. Hormonal contraception (oral, transdermal, implanted, or injected formulations)&#xD;
&#xD;
          3. Selective estrogen receptor modulators (tamoxifen, raloxifene, or toremifene)&#xD;
&#xD;
          4. Aromatase inhibitors (anastrazole, letrozole, or exemestane)&#xD;
&#xD;
          5. GnRH analogs&#xD;
&#xD;
          6. Prolactin inhibitors&#xD;
&#xD;
          7. Androgens or antiandrogens&#xD;
&#xD;
          8. Anticoagulants or &quot;blood thinners&quot; (warfarin, heparin, rivaroxaban and other novel&#xD;
             anticoagulants)&#xD;
&#xD;
          9. Drugs known to be strong inhibitors of CYP2D6, the major P450 enzyme that metabolizes&#xD;
             tamoxifen, including:&#xD;
&#xD;
               -  bupropion (Wellbutrin)&#xD;
&#xD;
               -  fluoxetine (Prozac)&#xD;
&#xD;
               -  paroxetine (Paxil)&#xD;
&#xD;
               -  quinidine (Quinidex) 6) Personal history of any type of malignancy, with the&#xD;
                  exclusion of non-melanoma skin cancer, diagnosed prior to enrollment 7) Personal&#xD;
                  history or strong family history of blood clots in legs or lungs (also known as&#xD;
                  deep vein thrombosis or pulmonary embolism) 8) Personal history of transient&#xD;
                  ischemic attack (TIA) or cerebrovascular accident (CVA) 9) Active proliferative&#xD;
                  disorders of the endometrium such as atypical hyperplasia, history of active&#xD;
                  endometriosis, unresected polyps 10) Any type of retinal disorders or severe&#xD;
                  cataract 11) Current or former smoker 12) Known carrier of BRCA1 or BRCA2 genetic&#xD;
                  mutation or known DNA repair defect.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carrie Hruska, PhD R-D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <results_first_submitted>April 29, 2019</results_first_submitted>
  <results_first_submitted_qc>April 29, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 16, 2019</results_first_posted>
  <last_update_submitted>April 29, 2019</last_update_submitted>
  <last_update_submitted_qc>April 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Carrie Hruska</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tamoxifen</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT02979301/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Tamoxifen 5 mg/Day</title>
          <description>Women with a history of high background uptake on MBI were enrolled.&#xD;
A baseline MBI was performed at Day 0. Women then took 5 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam.</description>
        </group>
        <group group_id="P2">
          <title>Tamoxifen 10 mg/Day</title>
          <description>Women with a history of high background uptake on MBI were enrolled.&#xD;
A baseline MBI was performed at Day 0. Women then took 10 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tamoxifen 5 mg/Day</title>
          <description>Women with a history of high background uptake on MBI were enrolled.&#xD;
A baseline MBI was performed at Day 0. Women then took 5 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam.</description>
        </group>
        <group group_id="B2">
          <title>Tamoxifen 10 mg/Day</title>
          <description>Women with a history of high background uptake on MBI were enrolled.&#xD;
A baseline MBI was performed at Day 0. Women then took 10 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="21"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.3" spread="4.4"/>
                    <measurement group_id="B2" value="48.1" spread="4.0"/>
                    <measurement group_id="B3" value="47.7" spread="4.1"/>
                  </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="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Background Parenchymal Uptake (BPU) on Molecular Breast Imaging (MBI)</title>
        <description>An image analysis tool to obtain a quantitative measure of background parenchymal uptake (BPU) was applied to pre-tamoxifen and post-tamoxifen MBI exams. The percent change in BPU from pre-tamoxifen to post-tamoxifen MBI was determined.</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tamoxifen 5 mg/Day</title>
            <description>Women with a history of high background uptake on MBI were enrolled.&#xD;
A baseline MBI was performed at Day 0. Women then took 5 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam.</description>
          </group>
          <group group_id="O2">
            <title>Tamoxifen 10 mg/Day</title>
            <description>Women with a history of high background uptake on MBI were enrolled.&#xD;
A baseline MBI was performed at Day 0. Women then took 10 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Background Parenchymal Uptake (BPU) on Molecular Breast Imaging (MBI)</title>
          <description>An image analysis tool to obtain a quantitative measure of background parenchymal uptake (BPU) was applied to pre-tamoxifen and post-tamoxifen MBI exams. The percent change in BPU from pre-tamoxifen to post-tamoxifen MBI was determined.</description>
          <units>percent change in BPU</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="21"/>
                    <measurement group_id="O2" value="-12" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from baseline until the last study visit for each study subject, approximately 30 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Tamoxifen 5 mg/Day</title>
          <description>Women with a history of high background uptake on MBI were enrolled.&#xD;
A baseline MBI was performed at Day 0. Women then took 5 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam.</description>
        </group>
        <group group_id="E2">
          <title>Tamoxifen 10 mg/Day</title>
          <description>Women with a history of high background uptake on MBI were enrolled.&#xD;
A baseline MBI was performed at Day 0. Women then took 10 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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. Carrie Hruska</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-293-4719</phone>
      <email>hruska.carrie@mayo.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/NCT02979301
org study id: IRB 16-008736
nct id: NCT02979301
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will examine whether changes in background parenchymal uptake (BPU) on molecular
      breast imaging (MBI) can be induced by short-term use of low-dose tamoxifen. Women who have
      previously had high BPU on MBI will be recruited. Participants will take low-dose tamoxifen
      for a 30-day period, with post-tamoxifen MBI in order to investigate the impact of tamoxifen
      on BPU.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in Background Parenchymal Uptake (BPU) on Molecular Breast Imaging (MBI)
time frame: 30 days
description: An image analysis tool to obtain a quantitative measure of background parenchymal uptake (BPU) was applied to pre-tamoxifen and post-tamoxifen MBI exams. The percent change in BPU from pre-tamoxifen to post-tamoxifen MBI was determined.
arm group label: Tamoxifen 5 mg/day
arm group type: Experimental
description: Women with high background uptake on MBI take 5 mg tam per day for 30 days.
arm group label: Tamoxifen 10 mg/day
arm group type: Experimental
description: Women with high background uptake on MBI take 10 mg tam per day for 30 days.
intervention type: Drug
intervention name: Tamoxifen
description: 5 mg or 10 mg tamoxifen per day for 30 days.
arm group label: Tamoxifen 10 mg/day
arm group label: Tamoxifen 5 mg/day
criteria: 
gender: Female
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Carrie Hruska, PhD R-D
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Carrie Hruska
investigator title: Associate Professor
mesh term: Tamoxifen
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 