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)
University Hospital, Basel, Switzerland
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.
Description
Despite major morbidity, axillary lymph node dissection (ALND) is standard of care in patients with clinically node positive breast cancer (cN+ BC) who undergo upfront surgery, which is frequently indicated in case of luminal biology. Tailored axillary surgery (TAS) was shown to selectively target positive nodes, thereby removing significantly more nodes than sentinel lymph node biopsy (SLNB), but less nodes than ALND. Therefore, it is currently unclear if TAS in combination with axillary radiotherapy (ART) exposes the axilla to less harm compared to ALND. It is hypothesized that patient's qua…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 biops…
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)
- Duke University/Duke Cancer CenterDurham, North Carolina
- Sanatorio Parque Breast Cancer CenterRosario
- KH DornbirnDornbirn
- LKH FeldkirchFeldkirch
- MUI - Univ. Klinik f. Frauenheilkunde InnsbruckInnsbruck
- CIUSSS du Centre Ouest-de-l 'Ile-de-MontréalMontreal