Adherex Technologies Inc. has announced fifty percent (70/140) of the patients have been enrolled in the company's on-going Phase 2 clinical trial for Metastatic Breast Cancer.
The open-label study is comparing the antitumor activity and safety of completely oral Eniluracil plus 5-FU and Leucovorin regimen (Treatment Arm 1; n=80) versus Xeloda® (capecitabine) (Treatment Arm 2; n=60).
Eligible patients have been previously treated with an anthracycline and a taxane. Patients who have disease progression in Arm 2 may crossover to take Eniluracil plus 5-FU and Leucovorin (Treatment Arm X).
The eniluracil plus 5-FU and Leucovorin regimen has been active and generally well-tolerated in both Arm 1 and Arm X.
Adherex anticipates enrollment of all 140 patients during the third quarter of this year and final data for progression-free survival by first quarter of 2013.
The statistical comparison of Treatment Arms 1 and 2 will occur after the study has been completed.
"I am pleased to see the progress of this study," said Edgardo Rivera, MD, National Prinicipal Investigator for the trial and medical director at Banner MD Anderson Cancer Center in Gilbert, Ariz. "I am looking forward to reviewing the results of this trial with the goal of improving breast cancer treatment and survivor rates."