Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Neoadjuvant Therapy, Lymph Node Metastases. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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.
Detailed 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.
Primary outcome measures
- Disease free survival (DFS) [Time frame: 5 years]
- Breast cancer specific survival (BCSS) [Time frame: 5 years]
- Overall survival (OS) [Time frame: 5 years]
- Axillary recurrence rate (ARR) [Time frame: 5 years]
- Quality of life, as measured by EQ-5D-5L [Time frame: Baseline, and 1 and 5 years after baseline]
- 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]
- 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]
Eligibility criteria
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 and treatment of the breast and axilla
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 carcinoma of the cervix or breast
- Axillary surgery or radiotherapy before NST (this includes SLNB prior to NST)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 35 centers
- Jeroen Bosch Hospital — 's-Hertogenbosch
- Northwest Clinics — Alkmaar
- The Netherlands Cancer Institute — Amsterdam
- Gelre Hospital — Apeldoorn
- Rijnstate Hospital — Arnhem
- Red Cross Hospital — Beverwijk
- Alexander Monro Hospital — Bilthoven
- Amphia Hospital — Breda
- … and 27 more centers
Identifiers
NCT: NCT04486495 · 2020-12518