The use of neoadjuvant chemotherapy in breast cancer is expanding in the recent decade. Patients with good response to neoadjuvant chemotherapy could benefit from de-escalation of breast and axilla operation. However, breast tumor and involved axillary lymph node should be marked before the commencement of chemotherapy. This could facilitate subsequent operative planning and intraoperative assessment of disease response. This study aims to evaluate the feasibility of magnetic marker localization for non-palpable breast cancer and targeted axillary dissection in patients with node-positive breast cancer following neoadjuvant therapy
All patients with cT1-3N1 invasive ductal carcinoma planned for neoadjuvant chemotherapy and/or target therapy
mentally competent to give informed consent
Agreed to proceed with curative operation after chemotherapy and tentatively keen for breast conservative surgery and targeted axillary dissection after neoadjuvant chemotherapy
Radiologically 1-3 ipsilateral axillary lymph node metastases confirmed by cytology or biopsy
Presence of distant metastasis, inflammatory breast cancers, multi-centric breast cancers
History of previous ipsilateral axillary surgery or irradiation
Hypersensitivity to dextran compounds or iron
Iron overload disease
Single group
Magnetic seed localization
DeviceMagnetic seed guided localization
Successful localization of breast tumor and axillary lymph node
Successful surgical retrieval of magnetic seed marked breast tumor and axillary lymph node in intraoperative specimen mammogram (in percentage)
Percentage of patients that can avoid axillary lymph node dissection
Percentage of patients that can achieve nodal pathological complete response after neoadjuvant chemotherapy
Percentage of successful magnetic seed guided lumpectomy
Percentage of involved or close margins in lumpectomy specimen which require re-excision
Level of satisfaction from surgeons and radiologists
Level of satisfaction from surgeons and radiologists which will be determined by the satisfaction questionnaire
5-year local regional recurrence rate
5-year ipsilateral breast tumor recurrence rate and/or axillary recurrence rate
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The University of Hong Kong
Lead sponsor
Endomagnetics Ltd.
Collaborator
