Pertuzumab, a humanised monoclonal antibody, acts by inhibiting the binding of HER2 receptor from other HER receptors, resulting in suppression of cancer cell growth or lead to the death of the cancer cell.
The randomized double-blind placebo-controlled Phase III CLinical Evaluation Of Pertuzumab And TRAstuzumab (CLEOPATRA) study involving 808 HER2-positive mBC patients, evaluated the efficacy and safety profile of Pertuzumab in conjugation with Herceptin and docetaxel compared to Herceptin and docetaxel alone.
The study reported a median PFS improved by 6.1 months from 12.4 months for Herceptin and chemotherapy to 18.5 months for pertuzumab, Herceptin and chemotherapy.
The primary endpoint of the study includes progression-free survival (PFS), and the secondary endpoints are OS, PFS, safety profile, overall response rate (ORR), duration of response, time to symptom progression and correlation of biomarkers with clinical outcomes.