Abstract OT2-1-02: Clinical node negative breast cancer patients undergoing breast conserving therapy: follow-up versus sentinel lymph node biopsy
Authors: van Roozendaal LM , Smidt ML , de Wilt HHW , van Dalen T , Strobbe LJA , van der Hage J , Tjan-Heijnen VCG , Linn SC , Serroyen JL 
Published: August 2014

Abstract
Background: The ACOSOG-Z0011 study demonstrated no additional value of complementary axillary lymph node dissection in case of limited axillary sentinel lymph node (SLN) metastases in breast cancer patients undergoing breast conserving therapy1. Since axillary ultrasound can exclude advanced axillary metastatic disease pre-operative2, there is ample opportunity to evaluate whether SLN biopsies are still indicated in a selected group of breast cancer patients.
Trial design: A prospective non-inferiority randomized multicenter trial was designed.
Breast cancer patients with cT1-2N0 disease, with no evidence for axillary metastases on ultrasound, treated with breast conserving therapy (lumpectomy + whole breast radiotherapy), will be randomized between follow-up and SLN biopsy. If adjuvant systemic therapy is not indicated by tumor or patient characteristics, gene expression profiling may be used for evaluation. To assess Quality of Life, 3 validated questionnaires will be used: QLQ-C30, QLQ-BR 23 and Lymph-ICF3-5.
Eligibility criteria: – Women with histological confirmed cT1-2 invasive unilateral breast carcinoma– Clinical node negative: no palpable nodes at physical examination and an axillary ultrasound without signs of lymph node metastases (cyto-/histology if indicated)– Neoadjuvant systemic therapy is allowed.
Specific aims: Primary endpoint is the axillary recurrence rate. The number of delayed axillary dissections will be registered. Secondary endpoints are distant-disease free survival, overall survival, local recurrence, morbidity and Quality of Life.
Statistical methods: Based on a 5-year axillary recurrence free survival rate: failure rate of 0.99 for controls and a true failure rate of 0.96 (as considered acceptable) for study subjects. Overall, 2086 patients will be included to be able to reject the null hypothesis that the failure rate for experimental and control subjects is inferior by at least 5% (D = −5%) with probability of 0.8 and alpha of 5%.
Present accrual and target accrual: This study is expected to start in late 2012 after approval by the Ethical Medical Committee.
References
1. Giuliano, A.E., et al., Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA, 2011. 305(6): p. 569–75. 2. Neal, C.H., et al., Can preoperative axillary US help exclude N2 and N3 metastatic breast cancer? Radiology, 2010. 257(2): p. 335–41. 3. Aaronson, N.K., et al., The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst, 1993. 85(5): p. 365–76. 4. Sprangers, M.A., et al., The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol, 1996. 14(10): p. 2756–68. 5. Devoogdt, N., et al., Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF): reliability and validity. Phys Ther, 2011. 91(6): p. 944–57.
Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr OT2-1-02.