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Background  Aim of this prospective study was to predict response to neoadjuvant therapy in breast cancer patients using an  in vitro  breast cancer spheroid model.    Methods  Three-dimensional spheroids were directly generated from fresh breast tumor biopsies of 78 patients eligible for neoadjuvant therapy. Cell survival was measured after  in vitro  exposure to the equivalent therapeutic agents in the breast cancer spheroid model. Treatment results  in vitro  were correlated with pathological complete response (pCR, i.e. ypT0 ypN0) determined at surgery.    Results  A mean cell survival of 21.8 % was found in the breast cancer spheroid model for 22 patients with pCR versus 63.8 % in 56 patients without pCR ( P  = .001). The area under the receiver operator characteristic curve to predict pCR was 0.86 (95 % CI: 0.77 to 0.96) for cell survival  in vitro  compared to 0.80 (95 % CI: 0.70 to 0.90) for a combined model of conventional factors (hormone- and HER2 receptor, and age). A cutoff at 35 % cell survival for the spheroid model was proposed. Out of the 32 patients with values below this threshold, 21 patients (65.6 %) and one patient (2.2 %) with a cell survival greater than 35 % achieved pCR respectively; (sensitivity 95.5 % (95 % CI: 0.86 to 1.00); specificity 80.4 % (95 % CI: 0.70 to 0.91)). Extent of residual disease positively correlated with increased cell survival ( P  = .021).    Conclusion  The breast cancer spheroid model proved to be a highly sensitive and specific predictor for pCR after neoadjuvant chemotherapy in breast cancer patients.    Electronic supplementary material  The online version of this article (doi:10.1186/s12885-015-1491-7) contains supplementary material, which is available to authorized users.

Prospective cohort study using the breast cancer spheroid model as a predictor for response to neoadjuvant therapy – the SpheroNEO study