Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer
MINIMAX
1 other identifier
observational
549
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Longer than P75 for all trials
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2020
CompletedStudy Start
First participant enrolled
July 16, 2020
CompletedFirst Posted
Study publicly available on registry
July 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
August 24, 2022
August 1, 2022
7 years
July 7, 2020
August 23, 2022
Conditions
Outcome Measures
Primary Outcomes (7)
Disease free survival (DFS)
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)
BCSS is defined as the time interval between the date of diagnosis until death from the disease.
5 years
Overall survival (OS)
OS is defined as the time interval between the date of diagnosis until death from any cause.
5 years
Axillary recurrence rate (ARR)
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
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
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.
All domains are scored 0 to 100 points. Higher points represent a better outcome.
Baseline, and 1 and 5 years after baseline
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht University Medical Centerlead
- Erasmus Medical Centercollaborator
- The Netherlands Cancer Institutecollaborator
Study Sites (35)
Jeroen Bosch Hospital
's-Hertogenbosch, Netherlands
Northwest Clinics
Alkmaar, Netherlands
The Netherlands Cancer Institute
Amsterdam, Netherlands
Gelre Hospital
Apeldoorn, Netherlands
Rijnstate Hospital
Arnhem, Netherlands
Red Cross Hospital
Beverwijk, Netherlands
Alexander Monro Hospital
Bilthoven, Netherlands
Amphia Hospital
Breda, Netherlands
Van Weel-Bethesda
Dirksland, Netherlands
Slingeland Hospital
Doetinchem, Netherlands
Albert Schweitzer Hospital
Dordrecht, Netherlands
Gelderse Vallei Hospital
Ede, Netherlands
Catharina Hospital
Eindhoven, Netherlands
Máxima Medical Center
Eindhoven, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Martini Hospital
Groningen, Netherlands
Saxenburgh Medical Center
Hardenberg, Netherlands
Ziekenhuisgroep Twente
Hengelo, Netherlands
Tergooi Hospital
Hilversum, Netherlands
Spaarne Gasthuis
Hoofddorp, Netherlands
Dijklander Hospital
Hoorn, Netherlands
Medical Center Leeuwarden
Leeuwarden, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Alrijne Hospital
Leiderdorp, Netherlands
Haaglanden Medical Center
Leidschendam, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Canisius Wilhelmina Hospital
Nijmegen, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Franciscus Gasthuis
Rotterdam, Netherlands
Ikazia Hospital
Rotterdam, Netherlands
Maasstad Hospital
Rotterdam, Netherlands
Spijkenisse Medical Center
Spijkenisse, Netherlands
ZorgSaam Hospital
Terneuzen, Netherlands
Diakonessenhuis
Utrecht, Netherlands
Isala Hospital
Zwolle, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marjolein Smidt, MD, PhD
Maastricht University Medical Center
- PRINCIPAL INVESTIGATOR
Marie-Jeanne Vrancken Peeters, MD, PhD
The Netherlands Cancer Institute
- PRINCIPAL INVESTIGATOR
Linetta Koppert, MD, PhD
Erasmus Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2020
First Posted
July 24, 2020
Study Start
July 16, 2020
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
August 24, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share