1. POSNOC-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
- Author
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Wei Tan, Alastair Thompson, Alan Montgomery, Sarah Craig, Laura Ternent, Eleanor Mitchell, Lelia Duley, Ian Ellis, Alistair Ring, Nicole Francis, Hannah Price, David Dodwell, Elizabeth Miles, Rebecca Haydock, Margaret Childs, Mara Ozolins, Diane Whitham, Apostolos Fakis, David Whynes, Patricia Fairbrother, Robert Newcombe, Malcolm Reed, Daniel Davis, Tara Homer, Kathryn Monson, Ramsey Cutress, Valerie Jenkins, Lesley Fallowfield, Clare Brittain, Daniel Rea, Judith Bliss, Amit Goyal, G Bruce Mann, Robert E Coleman, Shabina Sadiq, Heath Badger, Rachel Helen Haines, Mickey Lewis, Daniel Megias, Zohal Nabi, Preetinder Singh, Andrei Caraman, Romaana Mir, Teresa Grieve, Clare Upton, Aisha Shafayat, Charlotte Gidman, Flonda Probert, Lisa Paksec, Rose Lucas, Annette Dempsey, Rochelle Thornton, Roeum Butt, Peter Barrett Lee, Julie Wolfarth, and Peter Dubsky
- Subjects
medicine.medical_specialty ,Breast surgery ,medicine.medical_treatment ,Breast Neoplasms ,breast tumours ,law.invention ,Breast cancer ,Randomized controlled trial ,adult radiotherapy ,law ,Internal medicine ,Breast-conserving surgery ,Adjuvant therapy ,Medicine ,Humans ,Mastectomy ,business.industry ,General Medicine ,Sentinel node ,breast surgery ,medicine.disease ,Radiation therapy ,Lymphatic Metastasis ,Axilla ,Quality of Life ,Lymph Node Excision ,Female ,Radiotherapy, Adjuvant ,Surgery ,business - Abstract
IntroductionACOSOG-Z0011(Z11) trial showed that axillary node clearance (ANC) may be omitted in women with ≤2 positive nodes undergoing breast conserving surgery (BCS) and whole breast radiotherapy (RT). A confirmatory study is needed to clarify the role of axillary treatment in women with ≤2 macrometastases undergoing BCS and groups that were not included in Z11 for example, mastectomy and those with microscopic extranodal invasion. The primary objective of POsitive Sentinel NOde: adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy (POSNOC) is to evaluate whether for women with breast cancer and 1 or 2 macrometastases, adjuvant therapy alone is non-inferior to adjuvant therapy plus axillary treatment, in terms of 5-year axillary recurrence.Methods and analysisPOSNOC is a pragmatic, multicentre, non-inferiority, international trial with participants randomised in a 1:1 ratio. Women are eligible if they have T1/T2, unifocal or multifocal invasive breast cancer, and 1 or 2 macrometastases at sentinel node biopsy, with or without extranodal extension. In the intervention group women receive adjuvant therapy alone, in the standard care group they receive ANC or axillary RT. In both groups women receive adjuvant therapy, according to local guidelines. This includes systemic therapy and, if indicated, RT to breast or chest wall. The UK Radiotherapy Trials Quality Assurance Group manages the in-built radiotherapy quality assurance programme. Primary endpoint is 5-year axillary recurrence. Secondary outcomes are arm morbidity assessed by Lymphoedema and Breast Cancer Questionnaire and QuickDASH questionnaires; quality of life and anxiety as assessed with FACT B+4 and State/Trait Anxiety Inventory questionnaires, respectively; other oncological outcomes; economic evaluation using EQ-5D-5L. Target sample size is 1900. Primary analysis is per protocol. Recruitment started on 1 August 2014 and as of 9 June 2021, 1866 participants have been randomised.Ethics and disseminationProtocol was approved by the National Research Ethics Service Committee East Midlands—Nottingham 2 (REC reference: 13/EM/0459). Results will be submitted for publication in peer-reviewed journals.Trial registration numberISRCTN54765244;NCT0240168Cite Now
- Published
- 2021