Trial Identifiers
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Scientific Title
POsitive Sentinel NOde: Adjuvant Therapy Alone Versus Adjuvant Therapy Plus Clearance or Axillary Radiotherapy. A Randomised Controlled Trial of Axillary Treatment in Women With Early Stage Breast Cancer Who Have Metastases in One or Two Sentinel Nodes
Other Non-Commercial Sponsor
Melbourne Health
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="">=50,>