Buzdar said that because of the significant results, the trial ™s Data Monitoring Committee determined that the trial should be closed so that more patients could take advantage of the superior treatment of chemotherapy combined with Herceptin.  Currently, all newly diagnosed patients at M. D. Anderson who have local, HER-2 positive breast disease receive the chemotherapy with Herceptin in advance of their surgery.

Patients enrolled on the study were randomized to four cycles of paclitaxel followed by four cycles of fluorouracil, epirubicin and cyclophosphamide alone or the same regimen with 24 weekly, simultaneous Herceptin treatments.  Following the chemotherapy with or without the Herceptin and surgery, patients received appropriate follow-up treatment.

Buzdar reported few major side effects, including heart damage, from the trial.  To offset known heart toxicities often attributed to Herceptin, patients received epirubicin as one of the three drugs in the chemotherapy regimen.  Epirubicin has been shown to be less toxic to the heart than others.  Fevers or neutropenia were experienced by a small percentage of patients, particularly among those on the Herceptin arm of the trial.

Buzdar said the research team would build on the data and experience gained from this trial and develop future trials that will explore results in a larger group of patients and look more closely at the effect the treatment may have on the type of surgery necessary after chemotherapy.

mdanderson