Abraxis reports positive preliminary results from Phase II breast cancer trial

In the preliminary analysis, 18% of patients (n=23) given a regimen of Abraxane (nab-paclitaxel), gemcitabine and epirubicin achieved a complete pathologic response and 68% (n=84) achieved a partial response.

In the ongoing Phase II study, 123 patients with locally advanced, early stage breast cancer were treated with nab-paclitaxel (175mg/m2), gemcitabine (2,000mg/m2) and epirubicin (50mg/m2) once every two weeks for 12 weeks followed by surgery.

Following surgery, patients were given additional treatment with nab-paclitaxel (220mg/m2) and gemcitabine (2,000mg/m2) administered once every two weeks for eight weeks. With this regimen, 88% of patients were alive 24 months after treatment and the estimated progression-free survival at 24 months was 71%.

Abraxane is currently in various stages of investigation for the treatment of the following cancers: first-line metastatic breast, non-small cell lung, malignant melanoma, pancreatic, gastric, and head and neck. Abraxane was developed by Abraxis BioScience and is marketed in the US under a co-promotion agreement between Abraxis and AstraZeneca.

Denise Yardley, program director of breast cancer at Sarah Cannon Research Institute, said: “The preliminary results of this study suggest antitumor activity for nab-paclitaxel in combination with gemcitabine and epirubicin in the treatment of breast cancer patients with locally advanced disease. Though further study is warranted, these results indicate that nab-paclitaxel could be an important addition to the combination treatments used in the neoadjuvant setting.”