Recruiting

TAS & ART

Sponsor:

University Hospital, Basel, Switzerland

Code:

NCT07140172

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Axillary lymph node dissection (ALND)

Axillary radiotherapy (ART)

Study Details

Brief summary:

This trial is to investigate if in patients with clinically node positive breast cancer undergoing upfront surgery, treatment with TAS and ART is superior to ALND in terms of arm-related Quality of Life (QoL) and occurrence of lymphedema two years after randomization.

Conditions

Breast Cancer

Study ID

NCT07140172

Start date

Jan 1, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2037

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1060 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm A (Control): ALND

1. Surgery: Tailored Axillary Surgery (TAS) includes the sentinel lymph node (SLN) procedure, radiographic confirmation of the removal of previously marked lymph nodes (clip removal), and the targeted excision of palpably suspicious lymph nodes.
2. Surgery: ALND - current standard of care, with the intention to remove the entire soft tissue within the anatomical borders of the axilla.
3. Radiotherapy: All patients receive adjuvant breast irradiation following breast-conserving surgery, along with extended regional lymph node irradiation (breast/chest wall irradiation excluding the axilla).

active comparator: Arm B (Investigational): ART

1. Surgery: Tailored Axillary Surgery (TAS) includes the sentinel lymph node (SLN) procedure, radiographic confirmation of the removal of previously marked lymph nodes (clip removal), and the targeted excision of palpably suspicious lymph nodes.
2. Radiotherapy: All patients receive adjuvant breast irradiation following breast-conserving surgery, along with extended regional lymph node irradiation (breast/chest wall irradiation excluding the axilla).TAS + breast/chest wall and axillary irradiation (ART)
3. Radiotherapy: Axillary radiotherapy (ART).

Interventions

Axillary lymph node dissection (ALND)

Surgical removal of lymphatic tissue within the anatomical boundaries of the axilla (standard of care in the upfront surgery setting in patients with cN+ BC)

Axillary radiotherapy (ART)

Axillary irradiation

Primary outcome measure

  • Change in arm-related Quality of Life (QoL) [ Time Frame: From baseline to 2 years after randomization ]
  • Occurrence of lymphedema [ Time Frame: From baseline to 2 years after randomization ]

Central Contacts and Locations

Central contacts

Walter P. Weber, Prof. Dr. med.

+41 61 328 61 49walter.weber@usb.ch

OPBC project management team

+41 61 55 65134noax.trial@usb.ch

Locations

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

Austin Williams

austin.williams@fccc.edu

CIUSSS du Centre Ouest-de-l 'Ile-de-Montréal

Recruiting

Montreal, Canada

Contacts

Stephanie Wong

sm.wong@mcgill.ca

More Information

Sponsor

University Hospital, Basel, Switzerland

Last update posted

Oct 14, 2026

Last verified

Oct, 2026

Keywords

  • axillary lymph node dissection (ALND)
  • axillary radiotherapy (ART)
  • tailored axillary surgery (TAS)
  • clinically node positive breast cancer (cN+ BC)
  • sentinel lymph node biopsy (SLNB)
  • Breast cancer-specific survival (BCSS)
  • NOAX
  • OPBC-10
  • Lymphedema
  • Quality of life (QoL)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University Hospital, Basel, Switzerland on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.