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

August 23, 2022 updated by: Maastricht University Medical Center

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.

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

549

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • 's Hertogenbosch, Netherlands
        • Recruiting
        • Jeroen Bosch Hospital
      • Alkmaar, Netherlands
        • Recruiting
        • Northwest Clinics
      • Amsterdam, Netherlands
        • Recruiting
        • The Netherlands Cancer Institute
      • Apeldoorn, Netherlands
        • Recruiting
        • Gelre Hospital
      • Arnhem, Netherlands
        • Recruiting
        • Rijnstate Hospital
      • Beverwijk, Netherlands
        • Recruiting
        • Red Cross Hospital
      • Bilthoven, Netherlands
        • Recruiting
        • Alexander Monro Hospital
      • Breda, Netherlands
        • Recruiting
        • Amphia Hospital
      • Dirksland, Netherlands
        • Recruiting
        • Van Weel-Bethesda
      • Doetinchem, Netherlands
        • Recruiting
        • Slingeland Hospital
      • Dordrecht, Netherlands
        • Recruiting
        • Albert Schweitzer Hospital
      • Ede, Netherlands
        • Recruiting
        • Gelderse Vallei Hospital
      • Eindhoven, Netherlands
        • Recruiting
        • Catharina hospital
      • Eindhoven, Netherlands
        • Recruiting
        • Maxima Medical Center
      • Enschede, Netherlands
        • Recruiting
        • Medisch Spectrum Twente
      • Groningen, Netherlands
        • Recruiting
        • Martini Hospital
      • Hardenberg, Netherlands
        • Recruiting
        • Saxenburgh Medical Center
      • Hengelo, Netherlands
        • Recruiting
        • Ziekenhuisgroep Twente
      • Hilversum, Netherlands
        • Recruiting
        • Tergooi Hospital
      • Hoofddorp, Netherlands
        • Recruiting
        • Spaarne Gasthuis
      • Hoorn, Netherlands
        • Recruiting
        • Dijklander Hospital
      • Leeuwarden, Netherlands
        • Recruiting
        • Medical Center Leeuwarden
      • Leiden, Netherlands
        • Recruiting
        • Leiden University Medical Center
      • Leiderdorp, Netherlands
        • Recruiting
        • Alrijne Hospital
      • Leidschendam, Netherlands
        • Recruiting
        • Haaglanden Medical Center
      • Maastricht, Netherlands
        • Recruiting
        • Maastricht University Medical Center
      • Nijmegen, Netherlands
        • Recruiting
        • Canisius Wilhelmina Hospital
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus Medical Center
      • Rotterdam, Netherlands
        • Recruiting
        • Maasstad Hospital
      • Rotterdam, Netherlands
        • Recruiting
        • Franciscus Gasthuis
      • Rotterdam, Netherlands
        • Recruiting
        • Ikazia Hospital
      • Spijkenisse, Netherlands
        • Recruiting
        • Spijkenisse Medical Center
      • Terneuzen, Netherlands
        • Recruiting
        • ZorgSaam Hospital
      • Utrecht, Netherlands
        • Recruiting
        • Diakonessenhuis
      • Zwolle, Netherlands
        • Recruiting
        • Isala hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival (DFS)
Time Frame: 5 years
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.
5 years
Breast cancer specific survival (BCSS)
Time Frame: 5 years
BCSS is defined as the time interval between the date of diagnosis until death from the disease.
5 years
Overall survival (OS)
Time Frame: 5 years
OS is defined as the time interval between the date of diagnosis until death from any cause.
5 years
Axillary recurrence rate (ARR)
Time Frame: 5 years
ARR is defined as tumor recurrence and as residual tumor that became clinically apparent in the ipsilateral axillary lymph nodes (pathologically proven).
5 years
Quality of life, as measured by EQ-5D-5L
Time Frame: Baseline, and 1 and 5 years after baseline
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').
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
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.
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
All domains are scored 0 to 100 points. Higher points represent a better outcome.
Baseline, and 1 and 5 years after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Erasmus Medical Center
The Netherlands Cancer Institute

Investigators

  • Principal Investigator: Marie-Jeanne Vrancken Peeters, MD, PhD, The Netherlands Cancer Institute
  • Principal Investigator: Linetta Koppert, MD, PhD, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 16, 2020

Primary Completion (ANTICIPATED)

July 1, 2027

Study Completion (ANTICIPATED)

July 1, 2027

Study Registration Dates

First Submitted

July 7, 2020

First Submitted That Met QC Criteria

July 22, 2020

First Posted (ACTUAL)

July 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-12518

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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