Halozyme Therapeutics announced that patient enrollment has been completed for a Phase 3 study of Herceptin SC (trastuzumab subcutaneous) for the treatment of HER2-positive breast cancer. This trial is a randomized, open-label, non-inferiority design that has enrolled 595 patients with early stage HER2-positive breast cancer. The study will evaluate two primary endpoints that compare Herceptin administered IV and SC for complete pathologic response between treatment cycles 8 and 9 and serum concentration during the first 8 cycles. Secondary endpoints will also be measured in this investigational study including an evaluation of safety and tolerability.
Herceptin SC uses Halozyme’s Enhanze technology (rHuPH20, recombinant human hyaluronidase) to deliver Herceptin (from Genentech) subcutaneously. Herceptin is approved to treat HER2-positive breast and gastric cancer and currently is given intravenously over 30 to 90 minutes.
For more information call (858) 794-8889 or visit www.halozyme.com.