The ethics approval of the institutional review board (Heidelberg University, Medical School, Germany) was obtained for the retrospective, anonymised, pooled analysis of the prospectively assembled data from all centres. At all sites, informed consent was obtained from each patient for the performance of the MIB after NACT as a diagnostic procedure. The study was organised and funded by the German Breast Group (data management and quality control) and the participating centres (equipment, personnel, local administration). Up to date, NACT results in a cCR rate of about 23–28% ( von Minckwitz et al, 2014a). This situation is both due to the widespread use of NACT and the growing efficiency of treatment protocols. We intentionally focused this study on a cohort of cCR cases because cCR after NACT is becoming more and more frequent. Patients were consecutively enroled if they had a cCR diagnosis (according to the definitions at unit level) after having received NACT. In this multicenter analysis, we included anonymised, prospectively assembled data of patients with histologically confirmed non-metastatic invasive breast cancers between 20. Owing to this diagnostic uncertainty, surgery after NACT is considered obligatory for all patients to completely remove residual disease in non-pCR cases and/or to diagnose a pCR ( NICE, 2009). For example, Schott et al determined the sensitivity of physical examination, mammography, ultrasound, and MRI for detecting a pCR in this situation to be 50%, 50%, 25%, and 25%, respectively ( Schott et al, 2005) Shin et al reported an accuracy of pCR prediction in cases with a cCR after NACT to be 38% for mammography, 13% for ultrasound, and 75% for MRI ( Shin et al, 2011). Definition and assessment of clinical complete response (cCR) differed relevantly among several imaging studies even if the procedures were based on the WHO ( Miller et al, 1981) or the EORTC/RECIST ( Eisenhauer et al, 2009) definitions. To assess clinical tumour response, physical examination, breast ultrasound, mammography, and breast magnetic resonance imaging may be used ( Fiorentino et al, 2001 Denis et al, 2004 Londero et al, 2004 Yeh et al, 2005), whereas breast MRI was found to be the most accurate to evaluate tumour response to NACT ( Croshaw et al, 2011 Marinovich et al, 2013). Tumour biology has already demonstrated to predict pCR to some extent for example, triple negative breast cancers (TNBC) show pCR rates of up to 64% ( von Minckwitz et al, 2014b) and for HER2+ tumours pCR rates of up to 66% ( Schneeweiss et al, 2013), but much lower pCR rates in luminal-type-like tumours ( von Minckwitz et al, 2012). Up to now, prediction of pCR, that is, diagnosing a pCR without surgery, is based on tumour biology at diagnosis, the applied NACT regimen and breast imaging results all with mediocre accuracy ( Gianni et al, 2005 Chagpar et al, 2006 Goldstein et al, 2007 Tiezzi et al, 2007 Shin et al, 2011). The most important precondition for such a trial would be an exact diagnosis of a pCR without surgery. In any case, these hypotheses still need to be tested in prospective, randomised trials. Extrapolating this to the extreme edge, patients with a pCR would require only a reduced extent of surgery or potentially no surgery at all ( Kummel et al, 2014). Recent studies have demonstrated that shrinking tumours need less surgical treatment ( von Minckwitz et al, 2008). As the achievement of pathological complete response (pCR) is significantly associated with a favourable disease free and overall survival, it is proposed as a surrogate clinical endpoint for long-term survival ( van der Hage et al, 2001 Bear et al, 2006 von Minckwitz et al, 2012 Cortazar et al, 2014). Neoadjuvant chemotherapy (NACT) is an increasingly used approach for patients with locally advanced or primarily inoperable breast cancer, and is an option for patients with potentially chemosensitive tumours ( Fisher et al, 1997 Kaufmann et al, 2006).
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