Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer

Last updated: August 23, 2022
Sponsor: Maastricht University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT04486495
2020-12518
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female patient with unilateral invasive breast cancer and cN1-3
  • Pathologically proven positive axillary lymph node
  • Planned to undergo neoadjuvant chemotherapy (± immunotherapy), followed by staging andtreatment of the breast and axilla

Exclusion

Exclusion Criteria:

  • Clinically node negative breast cancer before NST
  • Bilateral invasive breast cancer
  • Neoadjuvant endocrine therapy
  • Distant metastases (including oligometastatic disease)
  • History of invasive breast cancer
  • Other malignancies, except for basal/squamous cell skin cancer, and in situ carcinomaof the cervix or breast
  • Axillary surgery or radiotherapy before NST (this includes SLNB prior to NST)

Study Design

Total Participants: 549
Study Start date:
July 16, 2020
Estimated Completion Date:
July 01, 2027

Study Description

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.

Connect with a study center

  • Jeroen Bosch Hospital

    's Hertogenbosch,
    Netherlands

    Active - Recruiting

  • Northwest Clinics

    Alkmaar,
    Netherlands

    Active - Recruiting

  • The Netherlands Cancer Institute

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Gelre Hospital

    Apeldoorn,
    Netherlands

    Active - Recruiting

  • Rijnstate Hospital

    Arnhem,
    Netherlands

    Active - Recruiting

  • Red Cross Hospital

    Beverwijk,
    Netherlands

    Active - Recruiting

  • Alexander Monro Hospital

    Bilthoven,
    Netherlands

    Active - Recruiting

  • Amphia Hospital

    Breda,
    Netherlands

    Active - Recruiting

  • Van Weel-Bethesda

    Dirksland,
    Netherlands

    Active - Recruiting

  • Slingeland Hospital

    Doetinchem,
    Netherlands

    Active - Recruiting

  • Albert Schweitzer Hospital

    Dordrecht,
    Netherlands

    Active - Recruiting

  • Gelderse Vallei Hospital

    Ede,
    Netherlands

    Active - Recruiting

  • Catharina Hospital

    Eindhoven,
    Netherlands

    Active - Recruiting

  • Máxima Medical Center

    Eindhoven,
    Netherlands

    Active - Recruiting

  • Medisch Spectrum Twente

    Enschede,
    Netherlands

    Active - Recruiting

  • Martini Hospital

    Groningen,
    Netherlands

    Active - Recruiting

  • Saxenburgh Medical Center

    Hardenberg,
    Netherlands

    Active - Recruiting

  • Ziekenhuisgroep Twente

    Hengelo,
    Netherlands

    Active - Recruiting

  • Tergooi Hospital

    Hilversum,
    Netherlands

    Active - Recruiting

  • Spaarne Gasthuis

    Hoofddorp,
    Netherlands

    Active - Recruiting

  • Dijklander Hospital

    Hoorn,
    Netherlands

    Active - Recruiting

  • Medical Center Leeuwarden

    Leeuwarden,
    Netherlands

    Active - Recruiting

  • Leiden University Medical Center

    Leiden,
    Netherlands

    Active - Recruiting

  • Alrijne Hospital

    Leiderdorp,
    Netherlands

    Active - Recruiting

  • Haaglanden Medical Center

    Leidschendam,
    Netherlands

    Active - Recruiting

  • Maastricht University Medical Center

    Maastricht,
    Netherlands

    Active - Recruiting

  • Canisius Wilhelmina Hospital

    Nijmegen,
    Netherlands

    Active - Recruiting

  • Erasmus Medical Center

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Franciscus Gasthuis

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Ikazia Hospital

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Maasstad Hospital

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Franciscus Vlietland

    Schiedam,
    Netherlands

    Site Not Available

  • Spijkenisse Medical Center

    Spijkenisse,
    Netherlands

    Active - Recruiting

  • ZorgSaam Hospital

    Terneuzen,
    Netherlands

    Active - Recruiting

  • Diakonessenhuis

    Utrecht,
    Netherlands

    Active - Recruiting

  • Isala Hospital

    Zwolle,
    Netherlands

    Active - Recruiting

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