Schedule of enrolment, interventions, and follow-up for each participant
Timepoint | Study period | ||||||
Screening | Enrolment and treatment | Follow-up | |||||
−1 week | 0 (SrLNB) | 1 week | 1 month | 3 months | 6 months | 1–3 years | |
Enrolment | |||||||
Eligibility screening* | × | × | |||||
Informed consent† | × | ||||||
Physical examination† | × | × | × | × | |||
Imaging examination† | × | × | × | × | |||
Frozen section to SrLNB specimen‡ | × | ||||||
Interventions | |||||||
SrLNB without ALND | × | ||||||
RNI including the axilla | × | ||||||
Breast surgery | × | ||||||
Adjuvant systemic therapy | × | ||||||
Assessments | |||||||
Survival outcome | × | × | × | × | × | ||
Disease status | × | × | × | × | × | ||
Arm circumference | × | × | × | × | × | × | |
SFBIA | × | × | × | × | × | × | |
Questionnaire FACT-B | × | × | × | × | × | × | |
Questionnaire QuickDASqwH | × | × | × | × | × | × |
*Eligibility screen includes confirmation of positive axillary lymph nodes successfully marked by carbon nanoparticles and completion of NST.
†Physical examination and imaging examination are used to screen patients’ responses to NST. They will be pre-enrolled, and sign an written informed consent (see online supplemental material). Physical examination mainly includes palpation of the breast and axillary lymph node. Imaging examination mainly includes breast and axillary ultrasound and MRI.
‡Pre-enrolled patients with negative result in intraoperative rapid pathological examination to SLNB specimen will be enrolled, while with residual disease in the axilla will be excluded.
ALND, axillary lymph node dissection; FACT-B, Functional Assessment of Cancer Therapy - Breast; NST, neoadjuvant systemic therapy; QuickDASH, Quick Disability of the Arm, Shoulder, and Hand; RNI, regional lymph node radiotherapy; SFBIA, single-frequency bioimpedance analysis; SrLNB, stained region lymph node biopsy.