Patients and treatment

The G7 trial, “Nanoparticle-based Paclitaxel vs. Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto/{"type":"clinical-trial","attrs":{"text":"NCT01583426","term_id":"NCT01583426"}}NCT01583426),” was a two-arm randomized phase III trial comparing neoadjuvant nab-paclitaxel to solvent-based paclitaxel followed by standard chemotherapy combination of epirubicin and cyclophosphamide in patients with high-risk early-stage breast cancer (21–24). An overview of the trial is shown in Supplementary Fig. S1. Patients were recruited in multiple study sites in Germany. The study was approved by all respective ethic committees (Leading Ethics Committee was in the State of Berlin; 12/0002- ZS EK 13) and all patients gave a written informed consent. The study was conducted in accordance with the Declaration of Helsinki.

Enrolled patients had previously untreated unilateral or bilateral primary invasive breast cancer and were randomly assigned in a 1:1 ratio using dynamic allocation and Pocock minimization by breast cancer subtype, as well as Ki-67 and SPARC expression. Patients were treated for 12 weeks with either intravenous nab-paclitaxel 150 mg/m² (after study amendment, 125 mg/m²) on days 1, 8, and 15 for four 3-week cycles; or solvent-based intravenous paclitaxel 80 mg/m² on days 1, 8, and 15 for four 3-week cycles. Taxane treatment was followed in both groups by intravenous epirubicin 90 mg/m² plus intravenous cyclophosphamide 600 mg/m² on day 1 for four 3-week cycles.

A total of 1,206 patients received treatment (606 nab-paclitaxel, 600 solvent-based paclitaxel) in the G7 trial; 810 of them were HER2-negative (Supplementary Table S1).