Date: 2011-10-18
Type of information:
phase: 3
Announcement: results
Company: Roche (Switzerland)
Product: Herceptin® IV (trastuzumab)
Action mechanism: Herceptin® is a humanised antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential. It activates the body’s immune system and suppresses HER2 to target and destroy the tumour.
Disease: HER2-positive early breast cancer.
Therapeutic area: Cancer Oncology
Country:
Trial
details: HannaH is a Phase III, open-label study involving 596 women with HER2 positive early breast cancer. The study was designed to compare trastuzumab concentration in the blood (pharmacokinetics), efficacy and safety of Herceptin® SC to that of Herceptin® IV. The study met its co-primary endpoints which were trastuzumab concentration in the blood (serum concentrations) and efficacy. Secondary endpoints included event-free survival and overall survival. In the study the most common side effects seen were infections and abnormal blood counts (anaemia and low white blood count).
Latest
news: Roche announced that the Phase III HannaH study demonstrated comparable efficacy of a new, investigational subcutaneous (SC) formulation of Herceptin® (trastuzumab) to the standard intravenous (IV) infusion of Herceptin® in women with HER2-positive early breast cancer. The SC administration takes around 5 minutes to administer whereas the IV formulation (the current standard) takes around 30 minutes to infuse. Since the subcutaneous administration is an injection under the skin it may allow patients to spend less time in hospital receiving their treatment versus the intravenous method. The ready to use formulation may also significantly reduce pharmacy time as no medicine preparation time is required. No new safety signals were observed and adverse events were consistent with Herceptin® IV. Data from the study will be submitted for presentation at an upcoming medical meeting and will support a marketing application to regulatory authorities in the European Union.
