Breast Cancer
Conditions
Keywords
breast cancer, sentinel lymph node biopsy, axillary lymph node clearance, axillary lymph node dissection, macrometastases, axillary radiotherapy, POSNOC
Brief summary
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.
Interventions
OTHERAdjuvant therapy
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.
PROCEDUREAxillary treatment
Axillary treatment can be axillary node clearance or axillary radiotherapy as per local guidelines.
Sponsors
University of Nottingham
Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
NCRI Radiotherapy Trials QA Group (RTTQA)
Breast Cancer Trials, Australia and New Zealand
University Hospitals of Derby and Burton NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Unifocal or multi-focal invasive tumour with lesion ≤5 cm in its largest dimension, measured pathologically or largest invasive tumour diameter on radiology should be used for women who are randomised intra-operatively or undergo sentinel node biopsy before neoadjuvant therapy (tumour size should be based only on the single largest tumour; do not add the sizes together from the multiple foci) * At sentinel node biopsy have 1 or 2 nodes with macrometastases (tumour deposit \>2.0mm in largest dimension or defined as macrometastasis on molecular assay) * Fit for axillary treatment and adjuvant therapy * Have given written informed consent
Exclusion criteria
* bilateral invasive breast cancer * more than 2 nodes with macrometastases * neoadjuvant therapy for breast cancer except: * if sentinel node biopsy performed prior to neoadjuvant chemotherapy in women with early breast cancer * short duration of neoadjuvant endocrine therapy is acceptable (up to 3 months) * previous axillary surgery on the same body side as the scheduled sentinel node biopsy * not receiving adjuvant systemic therapy * previous cancer less than 5 years previously or concomitant malignancy except: * basal or squamous cell carcinoma of the skin * in situ carcinoma of the cervix * in situ melanoma * contra- or ipsilateral in situ breast cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axillary recurrence | 5 years | Axillary recurrence is defined as pathologically (cytology or biopsy) confirmed recurrence in lymph nodes draining the primary tumour site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 3 years | Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Breast+4 questionnaire. |
| Anxiety (Spielberger State/Trait Anxiety Inventory) | 3 years | Anxiety will be assessed with the Spielberger State/Trait Anxiety Inventory. |
| Economic evaluation (EQ-5D-5L (EuroQoL) | 3 years | Health-related quality of life will be evaluated using the EQ-5D-5L (EuroQoL) instrument. |
| Local (breast or chest wall) recurrence | 5 years | Number of participants with local (breast or chest wall) recurrence. |
| Regional (nodal) recurrence | 5 years | Number of participants with regional (nodal) recurrence. |
| Distant metastasis | 5 years | Number of participants with distant metastasis. |
| Arm morbidity | 3 years | Arm morbidity will be assessed by the Lymphoedema and Breast Cancer and QuickDASH (disabilities of the arm, shoulder and hand) questionnaires. |
| Axillary recurrence free survival | 5 years | — |
| Disease free survival | 5 years | — |
| Overall survival | 5 years | — |
| Contralateral breast cancer | 5 years | Number of participants with contralateral breast cancer. |
| Non-breast malignancy | 5 years | Number of participants with non-breast malignancy. |
| Time to axillary recurrence | 5 years | — |
Countries
Australia, New Zealand, United Kingdom
Outcome results
None listed