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

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Disease free survival (DFS) — 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.
• Breast cancer specific survival (BCSS) — 5 years
  BCSS is defined as the time interval between the date of diagnosis until death from the disease.
• Overall survival (OS) — 5 years
  OS is defined as the time interval between the date of diagnosis until death from any cause.
• Axillary recurrence rate (ARR) — 5 years
  ARR is defined as tumor recurrence and as residual tumor that became clinically apparent in the ipsilateral axillary lymph nodes (pathologically proven).
• Quality of life, as measured by EQ-5D-5L — 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').
• Quality of life, as measured by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-BR23 — 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.
• 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. — Baseline, and 1 and 5 years after baseline
  All domains are scored 0 to 100 points. Higher points represent a better outcome.

Trial sites (35)

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