Adjuvant Docetaxel in Node-Negative Breast Cancer Patients: A Randomized Trial of AGO-Breast Study Group, German Breast Group, and EORTC-Pathobiology Group.

Background: In node-negative breast cancer (NNBC), a high risk of recurrence is determined by clinico-pathological or tumor-biological assessment. Taxanes may improve adjuvant chemotherapy.

Methods: NNBC 3-Europe, the first randomized phase-3 trial in node-negative breast cancer (BC) with tumor-biological risk assessment, recruited 4146 node-negative breast cancer patients from 2002 to 2009 in 153 centers.

Neoadjuvant breast cancer treatment as a sensitive setting for trastuzumab biosimilar development and extrapolation.

Aims: Identify sensitive end points and populations for similarity studies of trastuzumab and biosimilar monoclonal antibodies.

Methods: We performed meta-analyses of trastuzumab clinical trials data: overall response rate (ORR) and progression-free survival in metastatic breast cancer (MBC), and total pathologic complete response (tpCR) and event-free survival in the neoadjuvant setting. Fitted models predicted the maximum loss in long-term efficacy for different similarity trial designs.

Neoadjuvant chemotherapy with paclitaxel and everolimus in breast cancer patients with non-responsive tumours to epirubicin/cyclophosphamide (EC) ± bevacizumab - results of the randomised GeparQuinto study (GBG 44).

Background: We tested the oral mammalian target of rapamycin (mTOR) inhibitor everolimus in addition to paclitaxel in patients with HER2-negative tumours not responding to initial neoadjuvant cytotoxic and anti-angiogenic treatment.

Methods: Patients with primary HER2-negative tumours received four neoadjuvant cycles of epirubicin/cyclophosphamide (EC) with or without bevacizumab. Patients without clinical response were randomised to receive weekly paclitaxel (80 mg/m(2)) with or without everolimus (5mg p.

The erbB2+ cluster of the intrinsic gene set predicts tumor response of breast cancer patients receiving neoadjuvant chemotherapy with docetaxel, doxorubicin and cyclophosphamide within the GEPARTRIO trial.

Gene expression profiling using Affymetrix HG-U133 Arrays (22,500 genes) was performed on fresh frozen pretherapeutic core biopsies from 50 patients undergoing neoadjuvant chemotherapy (NAC) with docetaxel, adriamycin, cyclophosphamide (TAC) within the GEPARTRIO trial. The Sorlie classification based on the "intrinsic gene set" revealed four different subgroups in our cohort (normal-like: 14%, basal-like: 20%, erbB2+: 22% and luminal: 44%), which is in line with the original description. High genomic grade but not histopathological grading was statistically different within the four subgroups (P<0.