xml: <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/NCT06008158</url>
    </required_header>
    <id_info>
      <org_study_id>23037</org_study_id>
      <secondary_id>NCI-2023-05718</secondary_id>
      <secondary_id>23037</secondary_id>
      <secondary_id>P30CA033572</secondary_id>
      <nct_id>NCT06008158</nct_id>
    </id_info>
    <brief_title>Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation for Improved Breast Appearance in Patients With Low Risk, Hormone Responsive Breast Cancer</brief_title>
    <official_title>Prospective Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation in Low-Risk, Hormone-Responsive Breast Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>City of Hope Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>City of Hope Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This phase II trial tests how well accelerated partial breast irradiation (APBI) delivered&#xD;
        once per day works in ensuring an acceptable breast appearance in patients with low risk,&#xD;
        hormone responsive breast cancer. APBI uses precise radiation beams to kill cancerous cells&#xD;
        in a smaller area of the breast (partial breast) instead of the whole breast or chest area as&#xD;
        in standard therapy. Additionally, APBI is given in a shorter course of treatment than whole&#xD;
        breast radiation therapy, over fewer days instead of several weeks, with a lower total dose&#xD;
        of radiation. APBI is currently given every other business day for a total of 5 treatments&#xD;
        with excellent results; however, a shorter treatment duration could have similar or even&#xD;
        better results. Undergoing APBI every day on consecutive business days for 5 treatments may&#xD;
        result in an improved breast appearance for patients with low risk hormone responsive breast&#xD;
        cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVES:&#xD;
  &#xD;
        I. To establish that APBI delivered once per day (APBI QD) for low-risk breast cancer&#xD;
        patients results in acceptable patient-reported cosmetic appearance of the breast at 1 year&#xD;
        after completion of APBI QD.&#xD;
  &#xD;
        SECONDARY OBJECTIVES:&#xD;
  &#xD;
        I. To determine the long-term patient-reported cosmetic appearance of the breast in patients&#xD;
        treated with APBI QD.&#xD;
  &#xD;
        II. To determine the short-term and long-term physician reported cosmetic appearance of the&#xD;
        breast in patients treated with APBI QD.&#xD;
  &#xD;
        III. To determine the acute and late patient-reported radiation toxicity of APBI QD.&#xD;
  &#xD;
        IV. To determine the acute and late physician-reported radiation toxicity of APBI QD.&#xD;
  &#xD;
        V. To determine the cancer control outcomes of APBI QD.&#xD;
  &#xD;
        EXPLORATORY OBJECTIVES:&#xD;
  &#xD;
        I. To assess the health-related quality of life in patients treated with APBI QD.&#xD;
  &#xD;
        II. To determine the long-term blinded physician review of cosmetic appearance of the breast&#xD;
        in patients treated with APBI.&#xD;
  &#xD;
        III. To assess dosimetric parameters associated with cosmesis in patients undergoing APBI QD.&#xD;
  &#xD;
        OUTLINE:&#xD;
  &#xD;
        Patients undergo APBI QD on consecutive business days for 5 treatments.&#xD;
  &#xD;
        Patients follow up at 1 month, 6 months, and 1 year post-APBI and then yearly until 5 years&#xD;
        post-APBI.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 9, 2023</start_date>
    <completion_date type="Anticipated">April 9, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 9, 2025</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Cosmetic outcome assessed by blinded medical doctor review.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of women that rate the cosmetic appearance of the breast as acceptable (&quot;excellent&quot; or &quot;good&quot;)</measure>
      <time_frame>At 1 year post accelerated partial breast irradiation once daily (APBI QD)</time_frame>
      <description>Measured by the 4-point Global Cosmetic Score (GCS). The exact test will be used to test the hypothesis that the rate of cosmesis is &gt;= 90% versus the null hypothesis that cosmesis is 74% or lower, at the 5% significance level.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cosmetic outcome by the patient post-APBI QD</measure>
      <time_frame>Over time at baseline, day 5, 1 month, 6 months, 1 year, 2 years and 3 years</time_frame>
      <description>Measured by the GCS. Will be summarized and the percent and 95% confidence limits of the estimate will be calculated. Will also examine at cosmesis scores over time using analysis of variance (ANOVA).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cosmetic outcome assessed by the physician post-APBI QD</measure>
      <time_frame>At 1 year</time_frame>
      <description>Measured by the GCS. Will explore also examine change in scores over time using ANOVA. Appropriate graphical methods will be used for visualization. Association between the assessment rating of cosmetic outcome based on photographic image by medical doctor (MD) and blinded reviewers will be calculated at each time point using Pearson's product-moment correlation coefficient.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cosmetic outcome assessed by the physician post-APBI QD</measure>
      <time_frame>Over time at baseline, day 5, 1 month, 6 months 1 year, 2 years and 3 years</time_frame>
      <description>Measured by the GCS. Will explore also examine change in scores over time using ANOVA. Association between the assessment rating of cosmetic outcome based on photographic image by MD and blinded reviewers will be calculated at each time point using Pearson's product-moment correlation coefficient.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of adverse events-patients reported</measure>
      <time_frame>Up to 3 years post-APBI</time_frame>
      <description>Scored by the Patient-Reported Outcome Common Terminology Criteria for Adverse Events (CTCAE). Will be summarized using standard methods.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of adverse events-treatment team reported</measure>
      <time_frame>Up to 3 years post-APBI</time_frame>
      <description>As scored by the treatment team using CTCAE version 5.0. Will be summarized using standard methods.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>In-breast recurrence</measure>
      <time_frame>Up to 5 years post-APBI QD</time_frame>
      <description>The Kaplan-Meier method will be used along with 95% confidence intervals.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Regional recurrence</measure>
      <time_frame>Up to 5 years post-APBI QD</time_frame>
      <description>The Kaplan-Meier method will be used along with 95% confidence intervals.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distant metastases</measure>
      <time_frame>Up to 5 years post-APBI QD</time_frame>
      <description>The Kaplan-Meier method will be used along with 95% confidence intervals.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease-free survival</measure>
      <time_frame>Up to 5 years post-APBI QD</time_frame>
      <description>The Kaplan-Meier method will be used along with 95% confidence intervals.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>Up to 5 years post-APBI QD</time_frame>
      <description>The Kaplan-Meier method will be used along with 95% confidence intervals.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Anatomic Stage 0 Breast Cancer AJCC v8</condition>
    <condition>Anatomic Stage IA Breast Cancer AJCC v8</condition>
    <condition>Estrogen Receptor-Positive Breast Carcinoma</condition>
    <condition>HER2-Negative Breast Carcinoma</condition>
    <arm_group>
      <arm_group_label>Supportive care (APBI)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients undergo APBI QD on consecutive business days for 5 treatments.</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Accelerated Partial Breast Irradiation</intervention_name>
      <description>Undergo APBI</description>
      <arm_group_label>Supportive care (APBI)</arm_group_label>
      <other_name>Accelerated Partial Breast Radiation Therapy</other_name>
      <other_name>APBI</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Documented informed consent of the participant and/or legally authorized&#xD;
               representative&#xD;
  &#xD;
            -  Age: &gt;= 40 years&#xD;
  &#xD;
            -  Female&#xD;
  &#xD;
            -  Ability to read and understand English or Spanish for questionnaires&#xD;
  &#xD;
            -  Anatomic pathologic stage 0 (ductal carcinoma in situ [DCIS]) or stage IA (invasive)&#xD;
               breast cancer&#xD;
  &#xD;
            -  Malignancy must be epithelial. Non-epithelial breast malignancies such as lymphoma or&#xD;
               sarcoma are not allowed&#xD;
  &#xD;
            -  Tissue from core biopsy or resection must show hormone sensitive receptors. Hormone&#xD;
               sensitive receptors are defined as the following:&#xD;
  &#xD;
                 -  - DCIS: Estrogen receptor (ER) positive (&gt;= 60%)&#xD;
  &#xD;
                 -  Invasive breast cancer:&#xD;
  &#xD;
                      -  Oncotype DX =&lt; 25 (if performed) OR&#xD;
  &#xD;
                      -  If Oncotype DX is not performed an Allred score of 7 or 8. The following&#xD;
                         combinations of proportion of ER positive cells and staining intensity are&#xD;
                         allowed:&#xD;
  &#xD;
                           -  ER positive (34-66% of cells) and staining intensity is strong (Allred&#xD;
                              7)&#xD;
  &#xD;
                           -  ER positive (&gt;= 67% of cells) and staining intensity is intermediate&#xD;
                              (Allred 7)&#xD;
  &#xD;
                           -  ER positive (&gt;= 67% of cells) and staining intensity is strong (Allred&#xD;
                              8)&#xD;
  &#xD;
            -  Tissue from core biopsy or resection must be HER2 negative by current American Society&#xD;
               of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines&#xD;
  &#xD;
            -  Patients must have undergone breast conserving surgery with resulting negative&#xD;
               surgical margins (no tumor on ink). Re-excision for negative margins is allowed.&#xD;
               Patients with pathologically involved surgical margins are excluded&#xD;
  &#xD;
            -  Patients must have pathologic Tis or T1 disease&#xD;
  &#xD;
            -  Patients with invasive breast cancer, including patients with microinvasion, must have&#xD;
               undergone surgical staging of the axilla (sentinel lymph node biopsy or axillary lymph&#xD;
               node dissection) and have pathologically confirmed uninvolved lymph nodes. All lymph&#xD;
               nodes must be pathologically negative (pN0[i-]). pN0(i+), pN1mic, pN1-pN3 axillary&#xD;
               lymph nodes are not allowed Although an axillary lymph node dissection is not&#xD;
               anticipated for low-risk ER positive breast cancers, axillary lymph node dissection is&#xD;
               permissible&#xD;
  &#xD;
            -  Patient must have physician-reported &quot;excellent&quot; or &quot;good&quot; cosmesis post-lumpectomy&#xD;
               and prior to radiation therapy based on the 4-point Global Cosmetic Score&#xD;
  &#xD;
            -  Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test.&#xD;
  &#xD;
                 -  If the urine test is positive or cannot be confirmed as negative, a serum&#xD;
                    pregnancy test will be required&#xD;
  &#xD;
            -  Agreement by females of childbearing potential* to use an effective method of birth&#xD;
               control or abstain from heterosexual activity for the course of the study through at&#xD;
               least 1 month after the last dose of protocol therapy&#xD;
  &#xD;
                 -  Childbearing potential is defined as not being surgically sterilized or have not&#xD;
                    been free from menses for &gt; 1 year&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any prior treatment with radiation therapy, anti-endocrine/hormone therapy,&#xD;
               chemotherapy or biologic therapy for the currently diagnosed breast cancer PRIOR to&#xD;
               surgical resection&#xD;
  &#xD;
            -  Prior radiation to the region of the involved breast that in the opinion of the&#xD;
               investigator would preclude partial breast irradiation&#xD;
  &#xD;
            -  Clinically significant uncontrolled illness&#xD;
  &#xD;
            -  Diagnosis of Paget's disease of the nipple&#xD;
  &#xD;
            -  Other prior or active malignancy. Patients with a prior or concurrent malignancy whose&#xD;
               natural history or treatment does not have the potential to interfere with the safety&#xD;
               or efficacy assessment of the investigational regimen are eligible for this trial&#xD;
  &#xD;
            -  Pregnant or breastfeeding&#xD;
  &#xD;
            -  Prospective participants who, in the opinion of the investigator, may not be able to&#xD;
               comply with all study procedures (including compliance issues related to&#xD;
               feasibility/logistics)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jose G Bazan</last_name>
      <role>Principal Investigator</role>
      <affiliation>City of Hope Medical Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>City of Hope Medical Center</name>
        <address>
          <city>Duarte</city>
          <state>California</state>
          <zip>91010</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jose G. Bazan</last_name>
        <phone>626-505-7901</phone>
        <email>jbazan@coh.org</email>
      </contact>
      <investigator>
        <last_name>Jose G. Bazan</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Breast Neoplasms</mesh_term>
      <mesh_term>Breast Carcinoma In Situ</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008158
  org study id: 23037
  secondary id: NCI-2023-05718
  secondary id: 23037
  secondary id: P30CA033572
  nct id: NCT06008158
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  This phase II trial tests how well accelerated partial breast irradiation (APBI) delivered
        once per day works in ensuring an acceptable breast appearance in patients with low risk,
        hormone responsive breast cancer. APBI uses precise radiation beams to kill cancerous cells
        in a smaller area of the breast (partial breast) instead of the whole breast or chest area as
        in standard therapy. Additionally, APBI is given in a shorter course of treatment than whole
        breast radiation therapy, over fewer days instead of several weeks, with a lower total dose
        of radiation. APBI is currently given every other business day for a total of 5 treatments
        with excellent results; however, a shorter treatment duration could have similar or even
        better results. Undergoing APBI every day on consecutive business days for 5 treatments may
        result in an improved breast appearance for patients with low risk hormone responsive breast
        cancer.
  PRIMARY OBJECTIVES:
  
        I. To establish that APBI delivered once per day (APBI QD) for low-risk breast cancer
        patients results in acceptable patient-reported cosmetic appearance of the breast at 1 year
        after completion of APBI QD.
  
        SECONDARY OBJECTIVES:
  
        I. To determine the long-term patient-reported cosmetic appearance of the breast in patients
        treated with APBI QD.
  
        II. To determine the short-term and long-term physician reported cosmetic appearance of the
        breast in patients treated with APBI QD.
  
        III. To determine the acute and late patient-reported radiation toxicity of APBI QD.
  
        IV. To determine the acute and late physician-reported radiation toxicity of APBI QD.
  
        V. To determine the cancer control outcomes of APBI QD.
  
        EXPLORATORY OBJECTIVES:
  
        I. To assess the health-related quality of life in patients treated with APBI QD.
  
        II. To determine the long-term blinded physician review of cosmetic appearance of the breast
        in patients treated with APBI.
  
        III. To assess dosimetric parameters associated with cosmesis in patients undergoing APBI QD.
  
        OUTLINE:
  
        Patients undergo APBI QD on consecutive business days for 5 treatments.
  
        Patients follow up at 1 month, 6 months, and 1 year post-APBI and then yearly until 5 years
        post-APBI.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  masking description: Cosmetic outcome assessed by blinded medical doctor review.
  measure: Proportion of women that rate the cosmetic appearance of the breast as acceptable ("excellent" or "good")
  time frame: At 1 year post accelerated partial breast irradiation once daily (APBI QD)
  description: Measured by the 4-point Global Cosmetic Score (GCS). The exact test will be used to test the hypothesis that the rate of cosmesis is >= 90% versus the null hypothesis that cosmesis is 74% or lower, at the 5% significance level.
  measure: Cosmetic outcome by the patient post-APBI QD
  time frame: Over time at baseline, day 5, 1 month, 6 months, 1 year, 2 years and 3 years
  description: Measured by the GCS. Will be summarized and the percent and 95% confidence limits of the estimate will be calculated. Will also examine at cosmesis scores over time using analysis of variance (ANOVA).
  measure: Cosmetic outcome assessed by the physician post-APBI QD
  time frame: At 1 year
  description: Measured by the GCS. Will explore also examine change in scores over time using ANOVA. Appropriate graphical methods will be used for visualization. Association between the assessment rating of cosmetic outcome based on photographic image by medical doctor (MD) and blinded reviewers will be calculated at each time point using Pearson's product-moment correlation coefficient.
  measure: Cosmetic outcome assessed by the physician post-APBI QD
  time frame: Over time at baseline, day 5, 1 month, 6 months 1 year, 2 years and 3 years
  description: Measured by the GCS. Will explore also examine change in scores over time using ANOVA. Association between the assessment rating of cosmetic outcome based on photographic image by MD and blinded reviewers will be calculated at each time point using Pearson's product-moment correlation coefficient.
  measure: Incidence of adverse events-patients reported
  time frame: Up to 3 years post-APBI
  description: Scored by the Patient-Reported Outcome Common Terminology Criteria for Adverse Events (CTCAE). Will be summarized using standard methods.
  measure: Incidence of adverse events-treatment team reported
  time frame: Up to 3 years post-APBI
  description: As scored by the treatment team using CTCAE version 5.0. Will be summarized using standard methods.
  measure: In-breast recurrence
  time frame: Up to 5 years post-APBI QD
  description: The Kaplan-Meier method will be used along with 95% confidence intervals.
  measure: Regional recurrence
  time frame: Up to 5 years post-APBI QD
  description: The Kaplan-Meier method will be used along with 95% confidence intervals.
  measure: Distant metastases
  time frame: Up to 5 years post-APBI QD
  description: The Kaplan-Meier method will be used along with 95% confidence intervals.
  measure: Disease-free survival
  time frame: Up to 5 years post-APBI QD
  description: The Kaplan-Meier method will be used along with 95% confidence intervals.
  measure: Overall survival
  time frame: Up to 5 years post-APBI QD
  description: The Kaplan-Meier method will be used along with 95% confidence intervals.
  arm group label: Supportive care (APBI)
  arm group type: Experimental
  description: Patients undergo APBI QD on consecutive business days for 5 treatments.
  intervention type: Radiation
  intervention name: Accelerated Partial Breast Irradiation
  description: Undergo APBI
  arm group label: Supportive care (APBI)
  other name: Accelerated Partial Breast Radiation Therapy
  other name: APBI
  criteria: 
  gender: Female
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jose G Bazan
  role: Principal Investigator
  affiliation: City of Hope Medical Center
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Breast Neoplasms
  mesh term: Breast Carcinoma In Situ