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Mothaffar Fahed Rimawi, MD, discusses the clinical implications of the phase 3 FeDeriCa trial in early-stage, HER2-positive breast cancer.
Mothaffar Fahed Rimawi, MD, professor, Department of Medicine, Section of Hematology and Oncology, executive medical director, associate director of clinical affairs, co-leader, Breast Cancer Program, chief of oncology service line, Dan L. Duncan Comprehensive Cancer Center, Baylor College of Medicine, discusses the clinical implications of the phase 3 FeDeriCa trial (NCT03493854) in early-stage, HER2-positive breast cancer.
The FeDeriCa trial randomized patients with operable, locally advanced or inflammatory stage II to IIIC, HER2-positive breast cancer to the fixed-dose, subcutaneously administered combination of trastuzumab (Herceptin) plus pertuzumab (Perjeta) vs an intravenously (IV) administered formulation of the combination. It was hypothesized that the subcutaneous formulation of trastuzumab/pertuzumab regimen would be less burdensome for patients after completion of neoadjuvant chemotherapy, Rimawi explains.
The primary end point of the study was noninferiority of the cycle 7 pertuzumab serum trough concentration within the fixed-dose combination for subcutaneous injection vs the IV combination. The results of the study showed that the primary end point was met. In addition, pathological complete response rates were comparable between regimens, which was reassuring that the efficacy of trastuzumab/pertuzumab was not affected by subcutaneous injection administration, Rimawi concludes.