Clinical trial NCT04486495: Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Neoadjuvant Therapy
Lymph Node Metastases
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: The Netherlands Cancer Institute
First posted: 2020-07-24
Enrollment: 549
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with unilateral invasive breast cancer and cN1-3, with a minimum of one pathologically proven positive axillary lymph node, treatment with neoadjuvant chemotherapy (± immunotherapy), followed by staging and treatment of the breast and axilla.

Brief 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.

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.

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)

Primary outcomes:
measure: Disease free survival (DFS)
timeFrame: 5 years
measure: Breast cancer specific survival (BCSS)
timeFrame: 5 years
measure: Overall survival (OS)
timeFrame: 5 years
measure: Axillary recurrence rate (ARR)
timeFrame: 5 years
measure: Quality of life, as measured by EQ-5D-5L
timeFrame: Baseline, and 1 and 5 years after baseline
measure: Quality of life, as measured by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-BR23
timeFrame: Baseline, and 1 and 5 years after baseline
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.
timeFrame: Baseline, and 1 and 5 years after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: 's Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Hospital
city: Alkmaar
country: Netherlands
facility: Northwest Clinics
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute
city: Apeldoorn
country: Netherlands
facility: Gelre Hospital
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Beverwijk
country: Netherlands
facility: Red Cross Hospital
city: Bilthoven
country: Netherlands
facility: Alexander Monro Hospital
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Dirksland
country: Netherlands
facility: Van Weel-Bethesda
city: Doetinchem
country: Netherlands
facility: Slingeland Hospital
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
city: Ede
country: Netherlands
facility: Gelderse Vallei Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Eindhoven
country: Netherlands
facility: Máxima Medical Center
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: Martini Hospital
city: Hardenberg
country: Netherlands
facility: Saxenburgh Medical Center
city: Hengelo
country: Netherlands
facility: Ziekenhuisgroep Twente
city: Hilversum
country: Netherlands
facility: Tergooi Hospital
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
city: Hoorn
country: Netherlands
facility: Dijklander Hospital
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Leiderdorp
country: Netherlands
facility: Alrijne Hospital
city: Leidschendam
country: Netherlands
facility: Haaglanden Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis
city: Rotterdam
country: Netherlands
facility: Ikazia Hospital
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
city: Spijkenisse
country: Netherlands
facility: Spijkenisse Medical Center
city: Terneuzen
country: Netherlands
facility: ZorgSaam Hospital
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Zwolle
country: Netherlands
facility: Isala Hospital
Study officials:
affiliation: Maastricht University Medical Center
name: Marjolein Smidt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Netherlands Cancer Institute
name: Marie-Jeanne Vrancken Peeters, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Linetta Koppert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: