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Tailored axillary surgery for node-positive breast cancer

Tailored Axillary Surgery With or Without Axillary Lymph Node Dissection Followed by Radiotherapy in Patients With Clinically Node-positive Breast Cancer (TAXIS). A Multicenter Randomized Phase III Trial (OPBC-03/ SAKK 23/16 /IBCSG 57-18 / ABCSG-53 / GBG-101)

Not applicable Interventional University Hospital, Basel, Switzerland · NCT03513614

This study tests if a new surgery that only removes affected lymph nodes can help people with node-positive breast cancer live as long and healthy as traditional surgery, while causing fewer side effects.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1500 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity Hospital, Basel, Switzerland Academic / other
Locations67 sites (Bethesda, Maryland and 66 other locations)
Trial IDNCT03513614 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of tailored axillary surgery (TAS) compared to traditional axillary lymph node dissection (ALND) in patients with node-positive breast cancer. TAS selectively removes only the affected lymph nodes, potentially reducing the complications associated with radical surgery. The study aims to determine if TAS combined with radiotherapy can achieve similar disease-free survival rates as ALND while minimizing side effects. By focusing on a more personalized surgical approach, the trial seeks to improve the quality of life for patients undergoing treatment.

Who should consider this trial

Good fit: Ideal candidates include adults with histologically or cytologically proven node-positive breast cancer, either newly diagnosed or with isolated in-breast recurrence.

Not a fit: Patients with non-node-positive breast cancer or those who are not eligible for axillary surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to fewer complications and a better quality of life for patients with node-positive breast cancer.

How similar studies have performed: Previous studies have shown promise with similar tailored surgical approaches, indicating potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Inclusion criteria at pre-registration:

* 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

Inclusion criteria at registration:

* 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.

Inclusion criteria at randomization (intraoperatively)

* 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

Exclusion Criteria:

Exclusion criteria at pre-registration:

Any potential patient who meets any of the following criteria has to be excluded from entering the trial.

* Stage IV breast cancer
* Clinical N3c breast cancer (clinical N3a and clinical N3b are allowed)
* Clinical N2b breast cancer (clinical N2a is allowed)
* Contralateral breast cancer within 3 years Note: Contralateral Ductal Carcinoma In Situ (DCIS) is allowed if prior treatment does not interfere with or compromise the trial treatment
* Prior axillary surgery (except prior sentinel node procedure in case of in- breast recurrence)
* Prior regional radiotherapy
* History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from pre-registration with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer.
* Treatment with any experimental drug within 30 days of pre-registration
* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.

Exclusion criteria at randomization (intraoperatively):

Any potential patient who meets any of the following criteria has to be excluded from the trial.

* Absence of clip in the specimen radiography
* Palpable disease left behind in the axilla after Tailored Axillary Surgery (TAS)
* No SLN identified in the axilla

Where this trial is running

Bethesda, Maryland and 66 other locations

+17 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Node-positive Breast CancerTailored Axillary SurgeryTAXISBreast Cancernode-positive breast cancerphase III trialIBCSG 57-18ABCSG
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.