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Breast Cancer Study: Comparing Axillary Surgery and Radiation

This study is for patients with breast cancer that has spread to the lymph nodes (node-positive breast cancer) who are having surgery first. It compares two ways to treat the underarm area (axilla): standard axillary lymph node dissection (ALND), which removes many lymph nodes, versus a newer approach called tailored axillary surgery (TAS) combined with axillary radiotherapy (ART), which uses radiation. The researchers want to see if TAS with ART leads to a better quality of life for your arm and fewer cases of swelling (lymphedema) compared to ALND. The study aims to enroll 1060 participants. The current status of the study is unclear.

Study design
This interventional study plans to enroll 1060 participants. It compares two different surgical and radiation approaches for breast cancer.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in arm-related quality of life and occurrence of lymphedema for up to 2 years after randomization.

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

NCT07140172

Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery

Recruiting
NAAges 18+InterventionalTreatment
University Hospital, Basel, Switzerland
~1,060 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:Axillary lymph node dissection (ALND)Axillary radiotherapy (ART)

At a glance

Recruiting sites
33 of 54 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in arm-related Quality of Life (QoL)
Measured over From baseline to 2 years after randomization
+1 more outcome measured

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

54 sites across 14 states
Switzerland24
Austria6
Ireland6
Germany4
Greece3
Italy2
Turkey (Türkiye)2
Maryland1

Study leadership

  • Walter P. Weber, Prof. Dr. med. · PRINCIPAL_INVESTIGATOR · Breast Surgery Service, University Hospital Basel

Who to contact

Walter P. Weber, Prof. Dr. med.
[email protected]
+41 61 328 61 49
Email the study team

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Eligibility criteria

Inclusion

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.
Node-positivity palpable (cN1-3) and confirmed by pathology.
Occult breast cancer is allowed, if biopsy-proven axillary lymphatic metastasis is present.
Eligible for primary ALND or SLN procedure 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.
Upfront surgery setting.
Most suspicious axillary lymph node clipped. (If clipping is not part of the routine, this should be done after consent of the patient as a study procedure.)
Ability to complete the QoL questionnaires.
WHO performance status 0-2
Adequate condition for general anesthesia, breast cancer surgery and radiotherapy.
Adult patients (≥18 years of age).
Women of child-bearing potential are using effective contraception (condom, diaphragm, intrauterine device), are not pregnant or lactating and agree not to become pregnant during trial treatment (until end of RT) and thereafter during the time recommended by the guidelines - also for adjuvant systemic therapies. A negative pregnancy test before registration is required for all women of child-bearing potential.
Men agree not to father a child during trial treatment and for 6 months afterward.

Exclusion

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.
Prior axillary surgery (except prior sentinel node procedure in case of in-breast recurrence).
Prior regional radiotherapy.
Neoadjuvant treatment with the exception of bridging therapy given for less than 3 months.
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.
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 TAS.
No SLN identified in the axilla.

What this trial measures

  • Change in arm-related Quality of Life (QoL)From baseline to 2 years after randomization

    The arm subscale (ARM) of the FACT-B+4 is used to assess arm-related QoL.The FACT-B comprises five subscales: physical well-being (seven items), social well-being (seven items), emotional well-being (six items), functional well-being (seven items), and concerns specific to patients with breast cancer (13 items). The FACT-B+4 questionnaire consists of the FACT-B subscales and the additional ARM subscale including five questions related to arm morbidity with four additional validated arm morbidity items that are added to the one item on arm morbidity already included in the FACT-B questionnaire. Patients are asked to indicate on a five- point scale from 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), to 4 (very much), to what degree each statement applied over the previous 7 days. The individual scoring of each question is inverted and added up to the total score ranging between 0 and 20 points, higher scores representing less arm problems.

  • Occurrence of lymphedemaFrom baseline to 2 years after randomization

    Bilateral measurements will be obtained 10 cm above and 5 cm below the olecranon process on both the ipsilateral and contralateral upper extremities. The change in ipsilateral upper- extremity circumference, corrected for any change in the contralateral upper extremity, will be calculated using the following formula: L = (Ia - Ib) - (Ca- Cb). It indicates ipsilateral upper-extremity circumference, C indicates contralateral upper- extremity circumference, a indicates assessments during trial treatment and follow-up, and b indicates baseline assessment. L will be calculated for both upper arm and forearm, and lymphedema is defined as present if L \> 2 cm for either location. The proportion of patients with lymphedema will be calculated.