Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer

N/ANot Yet RecruitingNCT06869629

Karolinska Institutet1,380 enrolled

Overview

SENOMAC-ULTRA enrols patients who are planned for upfront surgery for a breast cancer that has spread to lymph nodes in the armpit, and that have been detected already prior to surgery by imaging, e.g. ultrasonography. In this situation, a full axillary lymph node dissection, removing more than 10 lymph nodes from the arm pit, is unnecessarily extensive in about half of the patients. More extensive surgery leads to a risk for arm lymphedema and functional problems with the arm and shoulder region, which should be avoided if not beneficial for diagnosis or prognosis. This trial seeks to ascertain that less extensive surgery, performed by only removing the first lymph node/s in the armpit (the sentinel lymph node/s) and the known metastatic lymph nodes (targeted axillary dissection, TAD), offers non-inferior survival outcomes to a full axillary lymph node dissection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,380

Conditions

Breast Carcinoma Breast Cancer Breast Surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with primary invasive breast cancer clinical stage II-III * Palpable or non-palpable axillary metastases visible by ultrasound (other imaging accepted if confirmatory ultrasound is performed) and confirmed by fine needle aspiration or core biopsy * Written informed consent * Age ≥ 18 years Exclusion Criteria: * Distant metastases * Ipsilateral metastases in internal mammary, infra- or supraclavicular lymph nodes without confirmed axillary nodal involvement * Preoperative suspicion of extensive nodal involvement, i.e. locally advanced disease * Nodes fixed to each other or to neighbouring structures on palpation or imaging * History of contralateral invasive breast cancer within 5 years * Bilateral invasive breast cancer if (i) one side meets any exclusion criteria or (ii) both sides meet all inclusion criteria * Pregnancy * Neoadjuvant systemic treatment (short course of neoadjuvant endocrine therapy \<three months is allowed) * Medical contraindications for or expressed preoperative wish to abstain from radiotherapy or the recommended adjuvant systemic treatment which complies with standard of care, taking age and comorbidity into consideration * Inability to absorb or understand the meaning of the study information; for example, through disability, inadequate language skills or dementia

Outcomes

Primary Outcomes

Recurrence-free survival

Time to event where an event is death if any cause or a recurrence of breast cancer

Time frame: 5 years

Secondary Outcomes

Arm morbidity

Arm function as reported by patients via the Lymphedema Functioning, Disability and Health questionnaire (Lymph-ICF), which consists of 29 questions about impairments in function, activity limitations, and participation restrictions of patients with breast cancer and arm lymphedema. The questionnaire is divided into 5 domains: physical function, mental function, household activities, mobility activities, and life and social activities. Each item is scored on a visual analogue scale (0-100 mm) resulting in domain scores ranging from 0 to 100. Higher scores indicate more severe arm dysfunction. Lymph-ICF scores also categorize into "no problem", "a small problem", "a moderate problem", "a severe problem", and "a very severe problem".

Time frame: 1, 3, 5 years

Health-related quality of life

Health-related quality of life measured by EORTC C30. The EORTC QLQ-C30 questionnaire measures HRQoL among cancer patients in general and consists of 30 items divided into multi-item scales and single items. The multi-item scales include one global health and quality of life (QoL) scale, five function subscales (physical, role, emotional, cognitive, social) and three symptom subscales (fatigue, nausea and vomiting, pain). The single items are dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties. Each scale produces a total score from 0 to 100. High scores on functional subscales indicate better function, and high scores on symptom subscales indicate more severe problems.

Time frame: 1, 3, 5 years

Overall survival

Time to event where an event is death of any cause

Time frame: 5 years

Health-related quality of life - breast cancer

The EORTC QLQ-BR23 questionnaire measures functions and symptoms related to breast cancer treatment and consists of 23 items divided into two functional subscales (body image and sexuality) and three symptom subscales (systemic therapy side effects, arm symptoms, breast symptoms) and three single items (sexual enjoyment, upset by hair loss, future perspective). The functional and symptom subscales as well as the single items correspond to a response scale 1-4 (not at all, a little, quite a bit, very much). Each scale produces a total score from 0 to 100. High scores on functional subscales indicate better function, and high scores on symptom subscales indicate more severe problems.

Time frame: 1, 3, 5 years

Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts