About this trial
This trial is to investigate if in patients with clinically node positive breast cancer undergoing upfront surgery, treatment with TAS and ART is superior to ALND in terms of arm-related Quality of Life (QoL) and occurrence of lymphedema two years after randomization.
Eligibility criteria
Qualifiers
Written informed consent according to ICH/GCP regulations prior to any trial specific procedures.
Patients ≥ 18 years of age.
Node-positive breast cancer (histologically or cytologically proven both in primary tumor and in lymph node) American Joint Committee on Cancer/ International Union Against Cancer (AJCC/UICC) stage II-III (all molecular subtypes allowed).
Node-positivity detected by imaging and non-palpable (iN+) and confirmed by pathology.
Disqualifiers
Stage IV breast cancer.
Clinical N3c breast cancer without axillary disease (clinical N3a and clinical N3b are allowed).
Clinical N2b breast cancer (clinical N2a is allowed).
Contralateral breast cancer within 3 years.
Trial design
Treatments tested in this trial
- Axillary lymph node dissection (ALND)
- Axillary radiotherapy (ART)