Study protocol

the SENOMAC trial study protocol

 

The SENOMAC trial includes patients according to the following in- and exclusion criteria. Please observe that from February 22, 2016, clinically node-negative patients receiving neoadjuvant treatment and undergoing sentinel node biopsy prior to treatment are eligible to be included in the SENOMAC trial.

.Inclusion criteria

•Patients with invasive breast cancer (T1-T3)

•No palpable lymph node metastases prior to sentinel node biopsy

•Macrometastasis in not more than 2 lymph nodes at sentinel node biopsy (further sentinel nodes with micrometastasis or ITC do not result in exclusion)

•Oral and written consent

•Age ≥ 18 years

•Preoperative ultrasound of axilla performed

 

Exclusion criteria

•Regional or distant metastases outside of the ipsilateral axilla

•Prior history of invasive breast cancer

•Pregnancy

•Bilateral invasive breast cancer, if one side meets exclusion criteria. Patients with bilateral cancers where both sides fulfill all inclusion criteria and no exclusion criteria may, however, not be included for either side.

•Medical contraindication for radiotherapy

•Medical contraindication for systemic treatment

•Inability to absorb or understand the meaning of the study information; for example, through disability, inadequate language skills or dementia.

 

After sentinel node biopsy yielding up to two lymph nodes with macrometastasis, randomization is performed 1:1 between the standard arm (completion axillary clearance) and the intervention arm (no further axillary surgery). For further details on treatment, follow-up and registration, you may access the full study protocol here. For patient information, please see under "Patient information".