<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/NCT02992574</url>
  </required_header>
  <id_info>
    <org_study_id>1602</org_study_id>
    <secondary_id>CTRI/2016/12/007532</secondary_id>
    <nct_id>NCT02992574</nct_id>
  </id_info>
  <brief_title>Trial Evaluating Role of Post Mastectomy Radiotherapy in Women With Node Negative Early Breast Cancer</brief_title>
  <acronym>PMRT-NNBC</acronym>
  <official_title>Post-Mastectomy Radiation Therapy in High Risk, Node Negative Women With Early Breast Cancer (PMRT-NNBC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tata Memorial Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tata Memorial Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postmastectomy radiotherapy (PMRT) is unequivocally beneficial in reducing the recurrences as&#xD;
      well as improving survival in node positive breast cancer patients. PMRT for women with T1-T2&#xD;
      tumors and negative axillary nodes is not generally warranted because of the presumed low&#xD;
      risk of recurrence in this population as a whole. However, in the setting of multiple adverse&#xD;
      prognostic factors, the recurrence risk approaches and in some cases surpasses the risk of&#xD;
      recurrence documented for patients with one to three positive lymph nodes. Numerous&#xD;
      retrospective series have reported the outcome and patterns of failure for post-mastectomy&#xD;
      patients treated without radiation. Many of these series have analyzed several high risk&#xD;
      factors which were predictive of loco-regional recurrence wherein the role of adjuvant&#xD;
      post-mastectomy radiation can be considered. Some authors have used combinations of&#xD;
      prognostic factors, such as age, tumour size, grade, receptor status, Her2neu status and&#xD;
      lympho-vascular space invasion to define subgroups with more specific risks of loco-regional&#xD;
      recurrence than single factors alone. The current trial hypothesizes that &quot;Post-mastectomy&#xD;
      radiation in high risk, node negative early breast cancer patients decreases rates of&#xD;
      loco-regional recurrence and improves disease free survival&quot; and propose to address the&#xD;
      question in randomized setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 27, 2016</start_date>
  <completion_date type="Anticipated">December 2033</completion_date>
  <primary_completion_date type="Anticipated">December 2028</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Arm Experimental Post Mastectomy Radiotherapy Arm No Intervention: No Post Mastectomy Radiotherapy</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>5 years</time_frame>
    <description>This will be measured using Kaplan Meier time to event analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chest wall recurrence</measure>
    <time_frame>5 years</time_frame>
    <description>This is the incidence of local recurrence in the chest wall</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regional recurrence</measure>
    <time_frame>5 years</time_frame>
    <description>This is the incidence of recurrence in the regional lymphatics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metastasis-free survival</measure>
    <time_frame>5 years</time_frame>
    <description>This will be measured using Kaplan Meier time to event analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>5 years</time_frame>
    <description>This will be measured using Kaplan Meier time to event analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Morbidity of radiotherapy</measure>
    <time_frame>4 weeks from the start of radiotherapy</time_frame>
    <description>RTOG Acute radiation morbidity scoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late Morbidity of radiotherapy</measure>
    <time_frame>6 months from end of radiotherapy to 5 years</time_frame>
    <description>RTOG Late radiation morbidity scoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life scores under different domains of the QLQ C-30 and BR-23 questionnaires</measure>
    <time_frame>5 years post surgery</time_frame>
    <description>Quality of life will be assesses by EORTC QLQ C-30 core questionnaire and the breast cancer specific module BR-23 questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1022</enrollment>
  <condition>Breastcancer</condition>
  <arm_group>
    <arm_group_label>Post Mastectomy Radiation Therapy (PMRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Post mastectomy radiotherapy will be given</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observation (No PMRT)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No adjuvant radiotherapy will be given.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Post Mastectomy Radiation therapy</intervention_name>
    <description>Post mastectomy radiotherapy to the chest wall and ipsilateral supra-clavicular fossa to a dose of 40 Gy in 15 fractions over 3 weeks</description>
    <arm_group_label>Post Mastectomy Radiation Therapy (PMRT)</arm_group_label>
    <other_name>PMRT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with unilateral pT1,2N0M0 breast cancer or multifocal breast cancer if largest&#xD;
             discrete tumour at least 2cm or if the tumour area comprises multiple small adjacent&#xD;
             foci of invasive carcinoma then overall maximum dimension taken. This must be greater&#xD;
             than 2cm.&#xD;
&#xD;
          -  Upfront total mastectomy (with minimum 1 mm margin clear of invasive cancer or DCIS)&#xD;
             and axillary staging procedure (clearance, sampling or SNB)&#xD;
&#xD;
          -  T2 tumors with one risk factor or T1 tumors with any of the following two high risk&#xD;
             factors such as presence of high grade, lymphovascular invasion, ER/PR negative, HER2&#xD;
             positivity, age &lt; 35 years.&#xD;
&#xD;
          -  Fit to receive adjuvant radiation +/- chemotherapy (if indicated) +/- hormonal therapy&#xD;
             (if indicated)&#xD;
&#xD;
          -  Written, informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any pTis/3/4, M1 patients&#xD;
&#xD;
          -  Patients who have any pathologically involved axillary nodes (micro-metastasis may be&#xD;
             allowed)&#xD;
&#xD;
          -  Patients who have undergone neoadjuvant systemic therapy.&#xD;
&#xD;
          -  Previous or concurrent malignancy other than non melanomatous skin cancer and&#xD;
             carcinoma in situ of the cervix&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Bilateral breast cancer&#xD;
&#xD;
          -  Not fit for surgery, radiotherapy or adjuvant systemic therapy&#xD;
&#xD;
          -  Unable or unwilling to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tabassum Wadasadawala, MBBS,MD,DNB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor, Radiation Oncology, Tata Memorial Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tabassum Wadasadawala, MBBS,MD,DNB</last_name>
    <phone>02227405078</phone>
    <email>twadasadawala@actrec.gov.in</email>
  </overall_contact>
  <location>
    <facility>
      <name>Max Super Speciality Hospital(A unit of Devki Devi Foundation)</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110017</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anil K Anand, MBBS,MD</last_name>
      <phone>9810398838</phone>
      <email>akanand@maxhealthcare.com</email>
    </contact>
    <investigator>
      <last_name>Anil K Anand, MBBS,MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>All India Institute of Medical Sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ritesh Kumar, MBBS, MD</last_name>
      <phone>9953774134</phone>
      <email>riteshkr9@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Ritesh Kumar, MBBS, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kolhapur Cancer Centre Pvt Ltd</name>
      <address>
        <city>Kolhapur</city>
        <state>Maharashtra</state>
        <zip>416234</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yogesh Anap, MBBS,MD,DNB</last_name>
      <phone>9420635556</phone>
      <email>yogesh.anap1@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Yogesh Anap, MBBS,MD,DNB</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tata Memorial Centre</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400012</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tabassum Wadasadawala, MBBS,MD,DNB</last_name>
      <phone>02227405078</phone>
      <email>twadasadawala@actrec.gov.in</email>
    </contact>
    <investigator>
      <last_name>Tabassum Wadasadawala, MBBS,MD,DNB</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bhagwan Mahaveer Cancer Hospital and Research Centre</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <zip>302017</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Nidhi Patni, MBBS,MD</last_name>
      <phone>9828052239</phone>
      <email>nidhionco@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Nidhi Patni, MBBS, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Post Graduate Institute of Medical Education &amp; Research</name>
      <address>
        <city>Chandigarh</city>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Budhi S Yadav, MBBS,MD</last_name>
      <phone>9815981176</phone>
      <email>drbudhi@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Budhi S Yadav, MBBS,MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Max Super Speciality Hospital, Shalimar Bagh</name>
      <address>
        <city>Delhi</city>
        <zip>110088</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Vineeta Goel, MBBS, DNB</last_name>
      <phone>9818045469</phone>
      <email>vineetagoel@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Vineeta Goel, MBBS,DNB</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>July 4, 2022</last_update_submitted>
  <last_update_submitted_qc>July 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tata Memorial Centre</investigator_affiliation>
    <investigator_full_name>Dr. Tabassum Wadasadawala</investigator_full_name>
    <investigator_title>Associate Professor, Radiation Oncology</investigator_title>
  </responsible_party>
  <keyword>Post-Mastectomy Radiation</keyword>
  <keyword>Node Negative</keyword>
  <keyword>Early breast Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02992574
org study id: 1602
secondary id: CTRI/2016/12/007532
nct id: NCT02992574
lead sponsor: 
has dmc: Yes
Postmastectomy radiotherapy (PMRT) is unequivocally beneficial in reducing the recurrences as
      well as improving survival in node positive breast cancer patients. PMRT for women with T1-T2
      tumors and negative axillary nodes is not generally warranted because of the presumed low
      risk of recurrence in this population as a whole. However, in the setting of multiple adverse
      prognostic factors, the recurrence risk approaches and in some cases surpasses the risk of
      recurrence documented for patients with one to three positive lymph nodes. Numerous
      retrospective series have reported the outcome and patterns of failure for post-mastectomy
      patients treated without radiation. Many of these series have analyzed several high risk
      factors which were predictive of loco-regional recurrence wherein the role of adjuvant
      post-mastectomy radiation can be considered. Some authors have used combinations of
      prognostic factors, such as age, tumour size, grade, receptor status, Her2neu status and
      lympho-vascular space invasion to define subgroups with more specific risks of loco-regional
      recurrence than single factors alone. The current trial hypothesizes that "Post-mastectomy
      radiation in high risk, node negative early breast cancer patients decreases rates of
      loco-regional recurrence and improves disease free survival" and propose to address the
      question in randomized setting.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Arm Experimental Post Mastectomy Radiotherapy Arm No Intervention: No Post Mastectomy Radiotherapy
primary purpose: Treatment
masking: None (Open Label)
measure: Disease free survival
time frame: 5 years
description: This will be measured using Kaplan Meier time to event analysis
measure: Chest wall recurrence
time frame: 5 years
description: This is the incidence of local recurrence in the chest wall
measure: Regional recurrence
time frame: 5 years
description: This is the incidence of recurrence in the regional lymphatics
measure: Metastasis-free survival
time frame: 5 years
description: This will be measured using Kaplan Meier time to event analysis
measure: Overall survival
time frame: 5 years
description: This will be measured using Kaplan Meier time to event analysis
measure: Acute Morbidity of radiotherapy
time frame: 4 weeks from the start of radiotherapy
description: RTOG Acute radiation morbidity scoring
measure: Late Morbidity of radiotherapy
time frame: 6 months from end of radiotherapy to 5 years
description: RTOG Late radiation morbidity scoring
measure: Quality of life scores under different domains of the QLQ C-30 and BR-23 questionnaires
time frame: 5 years post surgery
description: Quality of life will be assesses by EORTC QLQ C-30 core questionnaire and the breast cancer specific module BR-23 questionnaire
arm group label: Post Mastectomy Radiation Therapy (PMRT)
arm group type: Experimental
description: Post mastectomy radiotherapy will be given
arm group label: Observation (No PMRT)
arm group type: No Intervention
description: No adjuvant radiotherapy will be given.
intervention type: Radiation
intervention name: Post Mastectomy Radiation therapy
description: Post mastectomy radiotherapy to the chest wall and ipsilateral supra-clavicular fossa to a dose of 40 Gy in 15 fractions over 3 weeks
arm group label: Post Mastectomy Radiation Therapy (PMRT)
other name: PMRT
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Tabassum Wadasadawala, MBBS,MD,DNB
role: Principal Investigator
affiliation: Assistant Professor, Radiation Oncology, Tata Memorial Centre
last name: Tabassum Wadasadawala, MBBS,MD,DNB
phone: 02227405078
email: twadasadawala@actrec.gov.in
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Tata Memorial Centre
investigator full name: Dr. Tabassum Wadasadawala
investigator title: Associate Professor, Radiation Oncology
mesh term: Breast Neoplasms
sharing ipd: No