<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/NCT04486495</url>
  </required_header>
  <id_info>
    <org_study_id>2020-12518</org_study_id>
    <nct_id>NCT04486495</nct_id>
  </id_info>
  <brief_title>Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer</brief_title>
  <acronym>MINIMAX</acronym>
  <official_title>Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer (MINIMAX): a Dutch Multicenter Observational Study to Gain Insight in Less and More Invasive Axillary Staging and Treatment in Relation to Oncologic Safety and Quality of Life to Develop Evidence-based Guidelines.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Netherlands Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht University Medical Center</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>
      Today, the majority of clinically node positive (cN+) breast cancer patients is treated with&#xD;
      neoadjuvant systemic therapy (NST). Axillary staging and treatment after NST in cN+ patients&#xD;
      are areas of controversy. Patients with a pathological complete response (pCR) of the&#xD;
      axillary lymph nodes are not expected to benefit from axillary lymph node dissection (ALND).&#xD;
      Hence, less invasive axillary staging procedures are being introduced to avoid unnecessary&#xD;
      ALND. However, evidence supporting the safety of replacing ALND by less invasive techniques&#xD;
      in terms of oncologic safety and impact on quality of life (QoL) is lacking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The MINIMAX is a multicenter registry study that includes node positive breast cancer&#xD;
      patients, who are treated with NST (chemotherapy and ± immunotherapy), in order to gain&#xD;
      insight in the oncologic safety and impact on QoL of less and more invasive axillary staging&#xD;
      and treatment strategies.&#xD;
&#xD;
      Patients who are included in this study will complete Patient Reported Outcome Measures&#xD;
      (PROMs) at baseline (time of diagnosis), and 1 and 5 years after diagnosis to assess impact&#xD;
      on QoL.&#xD;
&#xD;
      A database will be built by the Netherlands Cancer Registry. Data on patient-, tumor-,&#xD;
      pre-NST staging-, post-NST staging- and treatment-characteristics will be retrieved from&#xD;
      patients' records by trained data registrars of the Netherlands Comprehensive Cancer&#xD;
      Organisation (IKNL) using electronic case report forms (eCRFs). Five-year survival and&#xD;
      recurrence will be evaluated to determine oncologic safety.&#xD;
&#xD;
      The results will be incorporated in the national guidelines. In case of an equilibrium&#xD;
      between less and more invasive strategies, the data of this study will at least be extremely&#xD;
      suitable to be used in the shared decision making process.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2027</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Disease free survival (DFS)</measure>
    <time_frame>5 years</time_frame>
    <description>DFS is defined as the time interval between the date of diagnosis until the date that a patient survives without any signs or symptoms of the disease.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breast cancer specific survival (BCSS)</measure>
    <time_frame>5 years</time_frame>
    <description>BCSS is defined as the time interval between the date of diagnosis until death from the disease.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>5 years</time_frame>
    <description>OS is defined as the time interval between the date of diagnosis until death from any cause.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Axillary recurrence rate (ARR)</measure>
    <time_frame>5 years</time_frame>
    <description>ARR is defined as tumor recurrence and as residual tumor that became clinically apparent in the ipsilateral axillary lymph nodes (pathologically proven).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life, as measured by EQ-5D-5L</measure>
    <time_frame>Baseline, and 1 and 5 years after baseline</time_frame>
    <description>The EQ-5D-5L comprises a descriptive system questionnaire and a visual analogue scale (VAS). The descriptive system consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, participants choose one of 5 levels that best describes their health on that day (from 'no problem'= 1 to 'unable/extreme'= 5). The numbers chosen for the five dimensions are combined to give a 5 digit score (minimum score = 11111 maximum score = 55555). The VAS provides participant's rating of their health on a scale from 0 ('the worst health you can imagine') to 100 ('the best health you can imagine').</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life, as measured by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-BR23</measure>
    <time_frame>Baseline, and 1 and 5 years after baseline</time_frame>
    <description>These questionnaires contain functional domains, global health status, and symptom scales. For functional domains and global health status, scores range from 0 to 100 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life, as measured by BREAST-Q, which includes the following domains: satisfaction with breasts, psychosocial well being, physical well being, sexual well being.</measure>
    <time_frame>Baseline, and 1 and 5 years after baseline</time_frame>
    <description>All domains are scored 0 to 100 points. Higher points represent a better outcome.</description>
  </primary_outcome>
  <enrollment type="Anticipated">549</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Neoadjuvant Therapy</condition>
  <condition>Lymph Node Metastases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Female patients with unilateral invasive breast cancer and cN1-3, with a minimum of one&#xD;
        pathologically proven positive axillary lymph node, treatment with neoadjuvant chemotherapy&#xD;
        (± immunotherapy), followed by staging and treatment of the breast and axilla.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patient with unilateral invasive breast cancer and cN1-3&#xD;
&#xD;
          -  Pathologically proven positive axillary lymph node&#xD;
&#xD;
          -  Planned to undergo neoadjuvant chemotherapy (± immunotherapy), followed by staging and&#xD;
             treatment of the breast and axilla&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically node negative breast cancer before NST&#xD;
&#xD;
          -  Bilateral invasive breast cancer&#xD;
&#xD;
          -  Neoadjuvant endocrine therapy&#xD;
&#xD;
          -  Distant metastases (including oligometastatic disease)&#xD;
&#xD;
          -  History of invasive breast cancer&#xD;
&#xD;
          -  Other malignancies, except for basal/squamous cell skin cancer, and in situ carcinoma&#xD;
             of the cervix or breast&#xD;
&#xD;
          -  Axillary surgery or radiotherapy before NST (this includes SLNB prior to NST)&#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>Marjolein Smidt, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marie-Jeanne Vrancken Peeters, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Netherlands Cancer Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Linetta Koppert, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erasmus Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sabine de Wild, MD</last_name>
    <phone>+31433881574</phone>
    <email>s.dewild@maastrichtuniversity.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Janine Simons, MD, PhD</last_name>
    <email>j.simons@maastrichtuniversity.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Jeroen Bosch Hospital</name>
      <address>
        <city>'s Hertogenbosch</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Northwest Clinics</name>
      <address>
        <city>Alkmaar</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Netherlands Cancer Institute</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gelre Hospital</name>
      <address>
        <city>Apeldoorn</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rijnstate Hospital</name>
      <address>
        <city>Arnhem</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Red Cross Hospital</name>
      <address>
        <city>Beverwijk</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Alexander Monro Hospital</name>
      <address>
        <city>Bilthoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Amphia Hospital</name>
      <address>
        <city>Breda</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Van Weel-Bethesda</name>
      <address>
        <city>Dirksland</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Slingeland Hospital</name>
      <address>
        <city>Doetinchem</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Albert Schweitzer Hospital</name>
      <address>
        <city>Dordrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gelderse Vallei Hospital</name>
      <address>
        <city>Ede</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Catharina Hospital</name>
      <address>
        <city>Eindhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Máxima Medical Center</name>
      <address>
        <city>Eindhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Medisch Spectrum Twente</name>
      <address>
        <city>Enschede</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Martini Hospital</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Saxenburgh Medical Center</name>
      <address>
        <city>Hardenberg</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ziekenhuisgroep Twente</name>
      <address>
        <city>Hengelo</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tergooi Hospital</name>
      <address>
        <city>Hilversum</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spaarne Gasthuis</name>
      <address>
        <city>Hoofddorp</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dijklander Hospital</name>
      <address>
        <city>Hoorn</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Medical Center Leeuwarden</name>
      <address>
        <city>Leeuwarden</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Leiden University Medical Center</name>
      <address>
        <city>Leiden</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Alrijne Hospital</name>
      <address>
        <city>Leiderdorp</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Haaglanden Medical Center</name>
      <address>
        <city>Leidschendam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Canisius Wilhelmina Hospital</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Franciscus Gasthuis</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ikazia Hospital</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Maasstad Hospital</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Spijkenisse Medical Center</name>
      <address>
        <city>Spijkenisse</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>ZorgSaam Hospital</name>
      <address>
        <city>Terneuzen</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Diakonessenhuis</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Isala Hospital</name>
      <address>
        <city>Zwolle</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2022</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>Breast Neoplasms</mesh_term>
    <mesh_term>Lymphatic Metastasis</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/NCT04486495
org study id: 2020-12518
nct id: NCT04486495
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Today, the majority of clinically node positive (cN+) breast cancer patients is treated with
      neoadjuvant systemic therapy (NST). Axillary staging and treatment after NST in cN+ patients
      are areas of controversy. Patients with a pathological complete response (pCR) of the
      axillary lymph nodes are not expected to benefit from axillary lymph node dissection (ALND).
      Hence, less invasive axillary staging procedures are being introduced to avoid unnecessary
      ALND. However, evidence supporting the safety of replacing ALND by less invasive techniques
      in terms of oncologic safety and impact on quality of life (QoL) is lacking.
The MINIMAX is a multicenter registry study that includes node positive breast cancer
      patients, who are treated with NST (chemotherapy and ± immunotherapy), in order to gain
      insight in the oncologic safety and impact on QoL of less and more invasive axillary staging
      and treatment strategies.

      Patients who are included in this study will complete Patient Reported Outcome Measures
      (PROMs) at baseline (time of diagnosis), and 1 and 5 years after diagnosis to assess impact
      on QoL.

      A database will be built by the Netherlands Cancer Registry. Data on patient-, tumor-,
      pre-NST staging-, post-NST staging- and treatment-characteristics will be retrieved from
      patients' records by trained data registrars of the Netherlands Comprehensive Cancer
      Organisation (IKNL) using electronic case report forms (eCRFs). Five-year survival and
      recurrence will be evaluated to determine oncologic safety.

      The results will be incorporated in the national guidelines. In case of an equilibrium
      between less and more invasive strategies, the data of this study will at least be extremely
      suitable to be used in the shared decision making process.
observational model: Cohort
time perspective: Prospective
measure: Disease free survival (DFS)
time frame: 5 years
description: DFS is defined as the time interval between the date of diagnosis until the date that a patient survives without any signs or symptoms of the disease.
measure: Breast cancer specific survival (BCSS)
time frame: 5 years
description: BCSS is defined as the time interval between the date of diagnosis until death from the disease.
measure: Overall survival (OS)
time frame: 5 years
description: OS is defined as the time interval between the date of diagnosis until death from any cause.
measure: Axillary recurrence rate (ARR)
time frame: 5 years
description: ARR is defined as tumor recurrence and as residual tumor that became clinically apparent in the ipsilateral axillary lymph nodes (pathologically proven).
measure: Quality of life, as measured by EQ-5D-5L
time frame: Baseline, and 1 and 5 years after baseline
description: The EQ-5D-5L comprises a descriptive system questionnaire and a visual analogue scale (VAS). The descriptive system consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, participants choose one of 5 levels that best describes their health on that day (from 'no problem'= 1 to 'unable/extreme'= 5). The numbers chosen for the five dimensions are combined to give a 5 digit score (minimum score = 11111 maximum score = 55555). The VAS provides participant's rating of their health on a scale from 0 ('the worst health you can imagine') to 100 ('the best health you can imagine').
measure: Quality of life, as measured by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-BR23
time frame: Baseline, and 1 and 5 years after baseline
description: These questionnaires contain functional domains, global health status, and symptom scales. For functional domains and global health status, scores range from 0 to 100 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms.
measure: Quality of life, as measured by BREAST-Q, which includes the following domains: satisfaction with breasts, psychosocial well being, physical well being, sexual well being.
time frame: Baseline, and 1 and 5 years after baseline
description: All domains are scored 0 to 100 points. Higher points represent a better outcome.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marjolein Smidt, MD, PhD
role: Principal Investigator
affiliation: Maastricht University Medical Center
last name: Marie-Jeanne Vrancken Peeters, MD, PhD
role: Principal Investigator
affiliation: The Netherlands Cancer Institute
last name: Linetta Koppert, MD, PhD
role: Principal Investigator
affiliation: Erasmus Medical Center
last name: Sabine de Wild, MD
phone: +31433881574
email: s.dewild@maastrichtuniversity.nl
last name: Janine Simons, MD, PhD
email: j.simons@maastrichtuniversity.nl
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Netherlands
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Lymphatic Metastasis
sharing ipd: No