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

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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.

ClinicalTrials.gov ID

NCT04486495

Acronym / sponsor ID

MINIMAX / 2020-12518

Conditions

Breast Cancer, Neoadjuvant Therapy, Lymph Node Metastases

Study type

Observational

Recruitment status

Recruiting

Enrolment

549 participants (estimated)

Lead sponsor

Maastricht University Medical CenterUniversity, hospital or other

Collaborators

Erasmus Medical Center, The Netherlands Cancer Institute

Study start

16 Jul 2020 (actual)

Primary completion

1 Jul 2027 (estimated)

Study completion

1 Jul 2027 (estimated)

First posted

24 Jul 2020 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Target follow-up

5 Years

Who may qualify

Ages

18 years and older

Sex

Female only

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

35 sites in 1 country: see every site and its status.