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news.Roche has completed patient recruitment for a randomised, open-label, pivotal Phase 3 study of Herceptin SC (trastuzumab subcutaneous), a subcutaneous formulation that uses Halozyme's Enhanze technology (rHuPH20, recombinant human hyaluronidase).
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In the study, the patients receive chemotherapy concurrent with either Herceptin intravenous (IV) or Herceptin SC every three weeks for the first 8 cycles.
Roche said that Herceptin is approved to treat HER2-positive breast and gastric cancer and currently is given intravenously over 30 to 90 minutes.
This subcutaneous alternative is expected to take less than five minutes to administer and should allow patients with HER2-positive breast cancer to receive their treatment in their physician’s office or potentially at home without having to go to a hospital.
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.