These final, confirmatory survival data from the CLEOPATRA study will be presented at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), Friday, December 7, 2012 (Abstract #P5-18-26, 5-7pm CT, Exhibit Hall A-B) by Dr. Sandra Swain, Medstar Washington Hospital Center.About the CLEOPATRA Study CLEOPATRA ( CL inical E valuation O f P ertuzumab A nd TRA stuzumab) is an international, Phase III, randomized, double-blind, placebo-controlled study. The study evaluated the efficacy and safety profile of Perjeta combined with Herceptin and docetaxel chemotherapy compared to Herceptin and docetaxel chemotherapy plus placebo in 808 people with previously untreated HER2-positive mBC or with HER2-positive mBC that had come back after prior therapy in the adjuvant or neoadjuvant setting. The primary endpoint of the study was progression-free survival (PFS) as assessed by an independent review committee. Secondary endpoints were overall survival, PFS by investigator assessment, safety profile, overall response rate (ORR), duration of response and time to symptom progression. PFS and safety data from CLEOPATRA were presented at SABCS 2011 and simultaneously published in the New England Journal of Medicine. PFS and Safety Results:
- People who received the combination of Perjeta, Herceptin and chemotherapy had a statistically significant 38 percent reduction in the risk of their disease worsening or death (PFS, HR=0.62; p<0.0001) compared to people who received Herceptin, chemotherapy and placebo.
- The median PFS improved by 6.1 months from 12.4 months for people who received Herceptin and chemotherapy to 18.5 months for those who received Perjeta, Herceptin and chemotherapy.
- The most common adverse events (AEs, rate greater than 30 percent) seen with the combination of Perjeta, Herceptin and chemotherapy were diarrhea, hair loss, low white blood cell count with or without fever, upset stomach, fatigue, rash and peripheral neuropathy (numbness, tingling or damage to the nerves). The most common Grade 3–4 AEs (rate greater than 2 percent) were low white blood cell count with or without fever, decrease in a certain type of white blood cell, diarrhea, damage to the nerves, decrease in red blood cell count, weakness and fatigue.