RecruitingNot ApplicableNCT07140172
Axillary Radiotherapy or Axillary Lymph Node Dissection in Patients With Clinically Node- Positive Breast Cancer Undergoing Upfront Tailored Axillary Surgery
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)
Sponsor
University Hospital, Basel, Switzerland
Enrollment
1,060 participants
Start Date
Jan 1, 2026
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria17
- 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 Criteria12
- 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.
Interventions
PROCEDUREAxillary 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)
PROCEDUREAxillary radiotherapy (ART)
Axillary irradiation
Locations(36)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07140172
Related Trials
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors
NCT0661828763 locations
Early Phase Study of KESONOTIDE™in Participants With Solid Tumours
NCT069260753 locations
Cardiac Outcomes With Near-Complete Estrogen Deprivation
NCT053096553 locations
Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors
NCT041190243 locations
EXploring Inflammation and Social deTerminants Study in Breast Cancer Patients
NCT074780161 location