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

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ClinicalTrials.gov Identifier: NCT04486495
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : March 4, 2021
Sponsor:
Collaborators:
Erasmus Medical Center
The Netherlands Cancer Institute
Information provided by (Responsible Party):
Maastricht University Medical Center

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.

Condition or disease
Breast Cancer Neoadjuvant Therapy Lymph Node Metastases

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 549 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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.
Actual Study Start Date : July 16, 2020
Estimated Primary Completion Date : July 1, 2027
Estimated Study Completion Date : July 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Overall survival (OS) [ Time Frame: 5 years ]
    OS is defined as the time interval between the date of diagnosis until death from any cause.

  4. 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. 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').

  6. 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.

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04486495


Contacts
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Contact: Sabine de Wild, MD +31433881574 s.dewild@maastrichtuniversity.nl
Contact: Janine Simons, MD, PhD j.simons@maastrichtuniversity.nl

Locations
Show Show 27 study locations
Sponsors and Collaborators
Maastricht University Medical Center
Erasmus Medical Center
The Netherlands Cancer Institute
Investigators
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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
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT04486495    
Other Study ID Numbers: 2020-12518
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphatic Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes