Tailored Axillary Surgery With or Without Axillary Lymph Node Dissection Followed by Radiotherapy in Patients With Clinically Node-positive Breast Cancer (TAXIS)

Inclusion Criteria

• •Written informed consent according to ICH/GCP regulations prior to any trial specific procedures.
• •Breast cancer, node positive detected by palpation or imaging (with or without planned neoadjuvant treatment)
• •Female or male aged ≥ 18 years
• •Ability to complete the Quality of Life questionnaires
• •Node-positive breast cancer (histologically or cytologically proven both in primary tumor and in lymph node) AJCC/UICC \[42\] stage II-III (all molecular subtypes allowed):
• •* Node-positivity detected by imaging (iN+) and confirmed by pathology
• •* Node-positivity detected by palpation (cN1-3) and confirmed by pathology
• •* Occult breast cancer is allowed, if biopsy-proven axillary lymphatic metastasis is present
• •Eligible for primary ALND or sentinel lymph node (SLN) procedure with frozen section and either:
• •* Newly diagnosed
• •* Isolated in-breast recurrence or second ipsilateral breast cancer after previous breast conserving surgery and sentinel procedure and at least 3 years disease free and no prior axillary dissection or axillary RT
• •Most suspicious axillary lymph node clipped
• •Baseline Quality of Life questionnaire has been completed
• •WHO performance status 0-2
• •Adequate condition for general anesthesia and breast cancer surgery
• •Women with child-bearing potential are using effective contraception, are not pregnant or lactating and agree not to become pregnant during trial treatment and thereafter during the time recommended by the guidelines for adjuvant systemic therapies. A negative pregnancy test before inclusion into the trial is required for all women with child-bearing potential.
• •Men agree not to father a child during trial treatment and thereafter during 6 months.
• •Node-positive breast cancer (histologically or cytologically proven both in primary tumor and in lymph node) AJCC/UICC stage II-III (all molecular subtypes allowed):
• •* Node-positivity initially detected by imaging and non-palpable and residual disease confirmed by pathology\*\* (including residual ITCs) in SLN or non SLN in case of prior neoadjuvant treatment
• •* Node-positivity initially palpable and residual disease confirmed by pathology\*\* (including residual ITCs) in case of prior neoadjuvant treatment
• •* Note: patients with ypN0(i+) can be included (the AJCC stage II-III refers to the stage before neoadjuvant treatment) \*\*Note: If the fine needle aspiration or core biopsy of the clipped node after neoadjuvant treatment unequivocally shows cancer, repeated confirmation of residual disease by intraoperative frozen section is not mandatory