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

Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery: An International, Randomized Superiority Trial (OPBC-10/ NOAX)

Not applicable Interventional University Hospital, Basel, Switzerland · NCT07140172

This trial tests whether targeted axillary surgery combined with axillary radiotherapy better preserves arm-related quality of life and reduces lymphedema than standard axillary lymph node dissection for people with clinically node-positive breast cancer having upfront surgery.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1060 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity Hospital, Basel, Switzerland Academic / other
Locations54 sites (Bethesda, Maryland and 53 other locations)
Trial IDNCT07140172 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with histologically or cytologically confirmed clinically node-positive (palpable or imaging-detected) stage II–III breast cancer who are planned for upfront surgery and can attend a participating site.

Not a fit: Patients with prior axillary dissection or prior axillary radiotherapy, those not eligible for upfront surgery, or those with medical reasons that preclude radiotherapy are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, replacing ALND with TAS plus ART could reduce arm complications and lymphedema and improve quality of life while maintaining cancer control.

How similar studies have performed: Some prior trials that reduced axillary surgery in clinically node-negative patients showed lower morbidity without worse cancer outcomes, but applying TAS plus ART in upfront clinically node-positive patients is relatively novel and not yet proven.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Bethesda, Maryland and 53 other locations

+4 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 Breast Canceraxillary lymph node dissectionaxillary radiotherapytailored axillary surgeryclinically node positive breast cancersentinel lymph node biopsyBreast cancer-specific survivalNOAX
Last reviewed 2026-06-15 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.