New Clinical Trials Demonstrate ABRAXANE®’s Efficacy in High Risk Early Breast Cancer

December 11, 2014 01:13 PM EST


The German Breast Group (GBG) said ABRAXANE (nab-paclitaxel) demonstrated significant benefit for patients with early high risk breast cancer when compared to conventional chemotherapy (solvent-based paclitaxel). The findings are from the GeparSepto clinical trial sponsored by GBG, involving over 1,200 patients – which is the largest randomized Phase III study ever completed with nab-paclitaxel and the first one completed in high risk early breast cancer.

The results were presented by the Berlin-based coordinating investigator Michael Untch, M.D. at the 2014 San Antonio Breast Cancer Symposium. “The Phase III study provided a head-to-head comparison of weekly nab-paclitaxel with weekly conventional paclitaxel in both arms before surgery. Our findings clearly demonstrate nab-paclitaxel is superior to paclitaxel in achieving pCRs in early high risk breast cancer,” Untch explained.

pCR, or pathological complete response, is an accepted indicator of long-term efficacy and is an important tool to drive innovation. Using markers such as pCR allows medications to be evaluated without waiting years to judge their efficacy.

Nab-Paclitaxel encapsulates paclitaxel in near-nano-sized albumin, protein shells. This leverages the natural attraction albumin has for the tumor, that senses the protein as nourishment. This allows for more drug at the tumor site, compared to solvent-based paclitaxel while maintaining tolerability.

GBG is a large independent academic network of over 500 study centers in Germany with the world-wide largest experience in conducting neoadjuvant breast cancer trials. Nab-paclitaxel is approved in the US and Europe for patients with metastatic breast cancer.

Read more about the implications of these important trials here.

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