Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection plus chemotherapy in HER2-positive early breast cancer (FeDeriCa): a randomised, open-label, multicentre, non-inferiority, phase 3 study
A fixed-dose subcutaneous formulation of pertuzumab and trastuzumAB with hyaluronidase was approved by the FDA. The Federica study was designed to assess the pharmacokinetics, efficacy, and safety of the formulation. Safety was similar between treatment groups, and in line with other pertuzumab, trastuzumab, and chemotherapy trials.
