Targeted axillary surgery plus radiotherapy versus full axillary lymph node removal for node-positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients with clinically node-positive stage II–III breast cancer who are undergoing upfront surgery are randomly assigned to either standard axillary lymph node dissection (ALND) or to tailored axillary surgery (TAS) followed by axillary radiotherapy (ART). TAS aims to remove the known positive nodes and fewer overall nodes than ALND, while ART treats the axilla with radiation. The trial measures arm-related quality of life and the occurrence of lymphedema two years after randomization as main outcomes. The study is led by University Hospital Basel with participating sites in the United States and follows participants through post-surgical follow-up and patient-reported outcome assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria at screening:

* 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 criteria at screening:

* 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.

Exclusion criteria at randomization (intraoperatively):

* Absence of clip in the specimen radiography.
* Palpable disease left behind in the axilla after TAS.
* No SLN identified in the axilla.

Where it's running

• Fox Chase Cancer Center
  Philadelphia, Pennsylvania, United States Recruiting
• KH Dornbirn
  Dornbirn, Austria Recruiting
• LKH Feldkirch
  Feldkirch, Austria Recruiting
• MUI - Univ. Klinik f. Frauenheilkunde Innsbruck
  Innsbruck, Austria Recruiting
• Ordensklinikum Linz
  Linz, Austria Recruiting
• Medical University Vienna, Department of Surgery
  Vienna, Austria Recruiting

+5 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Walter P. Weber, Prof. Dr. med. — Breast Surgery Service, University Hospital Basel
• Study coordinator: Walter P. Weber, Prof. Dr. med.
• Email: walter.weber@usb.ch
• Phone: +41 61 328 61 49

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.