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TAXIS Trial: Tailored Surgery and Radiotherapy for Node-Positive Breast Cancer

This study, called TAXIS, is looking for a better way to treat breast cancer that has spread to the lymph nodes (node-positive breast cancer). It compares two approaches: one where you receive "tailored axillary surgery" (a new technique to remove only affected lymph nodes) followed by radiation that avoids the surgically treated armpit area, and another where you receive tailored axillary surgery followed by radiation that includes the entire armpit. The goal is to see if tailored surgery can reduce side effects like swelling and pain while being just as effective as more extensive surgery. We're looking for 1500 participants aged 18 or older who have node-positive breast cancer. The main way we'll know if the treatment is successful is by measuring how long people live without the disease coming back.

Study design
This interventional study plans to enroll 1500 participants with node-positive breast cancer. It compares two different treatment approaches.
What's involved
You would need to provide written informed consent and be able to complete Quality of Life questionnaires. The specific number of visits or procedures beyond the surgery and radiotherapy is not detailed.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for disease-free survival (DFS) for up to 20 years after the last patient is randomized.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03513614

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

Active, Not Recruiting
NAAges 18+InterventionalTreatment
University Hospital, Basel, Switzerland
~1,500 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:Tailored axillary surgery - both ArmsRadiotherapy - Arm ARadiotherapy - Arm B

At a glance

Recruiting sites
0 of 64 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-free survival (DFS)
Measured over at the occurrence of the event or latest 20 years after randomization of the last patient

Conditions

Node-positive Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

64 sites across 18 states
Switzerland26
Austria9
Germany5
Greece5
Hungary3
Croatia2
Italy2
South Korea2

Study leadership

  • Walter P. Weber, Prof. · STUDY_CHAIR · University Hospital, Basel, Switzerland

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.
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

What this trial measures

  • Disease-free survival (DFS)at the occurrence of the event or latest 20 years after randomization of the last patient

    The primary endpoint of this trial is DFS, defined as time from randomization until one of the following events, whichever comes first: * Local recurrence, regional recurrence, distant recurrence * Second breast cancer * Death from any cause Patients not experiencing an event will be censored at the date of the last available assessment.