POSNOC is a pragmatic, randomised, multicentre, non-inferiority trial. Aim For women with early stage breast cancer and one or two sentinel node macrometastases, to assess whether adjuvant therapy alone is no worse than adjuvant therapy plus axillary treatment, in terms of axillary recurrence within 5 years. Stratification: Institution, Age (\<50, ≥50), Breast-conserving surgery (BCS) or mastectomy, Estrogen receptor (ER) status (positive, negative), Number of positive nodes (1, 2), Intra-operative sentinel assessment using OSNA (yes, no). Interventions The study will compare adjuvant therapy alone with adjuvant therapy plus axillary treatment (axillary node clearance (ANC) or axillary radiotherapy (ART)). Sample Size: 1900 participants Follow-up: Participants will be followed up for 5 years. Adjuvant Therapy: All participants will receive adjuvant systemic therapy (chemotherapy and/or endocrine therapy). All participants may receive breast/chest wall radiotherapy. Axillary and supraclavicular fossa radiotherapy is not allowed when randomised to adjuvant therapy alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,900
Adjuvant therapy will include chemotherapy and/or endocrine therapy for all women, and radiotherapy to breast or chest wall if indicated. Human epidermal growth factor receptor 2 (HER2) targeted treatment may also be administered when indicated.
Axillary treatment can be axillary node clearance or axillary radiotherapy as per local guidelines.
Royal Adelaide Hospital
Adelaide, Australia
Bankstown-Lidcocombe Hospital
Bankstown, Australia
Maeter Hospital
Brisbane, Australia
Coffs Harbour Health Campus
Coffs Harbour, Australia
Monash Cancer Centre
Melbourne, Australia
Royal Melbourne and Royal Women's Hospital
Axillary recurrence
Axillary recurrence is defined as pathologically (cytology or biopsy) confirmed recurrence in lymph nodes draining the primary tumour site.
Time frame: 5 years
Arm morbidity
Arm morbidity will be assessed by the Lymphoedema and Breast Cancer and QuickDASH (disabilities of the arm, shoulder and hand) questionnaires.
Time frame: 3 years
Quality of life
Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Breast+4 questionnaire.
Time frame: 3 years
Anxiety (Spielberger State/Trait Anxiety Inventory)
Anxiety will be assessed with the Spielberger State/Trait Anxiety Inventory.
Time frame: 3 years
Economic evaluation (EQ-5D-5L (EuroQoL)
Health-related quality of life will be evaluated using the EQ-5D-5L (EuroQoL) instrument.
Time frame: 3 years
Local (breast or chest wall) recurrence
Number of participants with local (breast or chest wall) recurrence.
Time frame: 5 years
Regional (nodal) recurrence
Number of participants with regional (nodal) recurrence.
Time frame: 5 years
Distant metastasis
Number of participants with distant metastasis.
Time frame: 5 years
Time to axillary recurrence
Time frame: 5 years
Axillary recurrence free survival
Time frame: 5 years
Disease free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Contralateral breast cancer
Number of participants with contralateral breast cancer.
Time frame: 5 years
Non-breast malignancy
Number of participants with non-breast malignancy.
Time frame: 5 years
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Melbourne, Australia
Sir Charles Gairdner Hospital
Perth, Australia
Riverina Cancer Care Centre
Wagga Wagga, Australia
Waikato Hospital
Hamilton, New Zealand
Rotorua Hospital
Rotorua, New Zealand
...and 40 more locations