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3 These guidelines incorporate absolute LVEF declines and the relationship of the LVEF to the institution-specific lower limit of the normal range. When treatment was reinitiated, trastuzumab was ...
The primary analysis of KATHERINE, a phase 3, open-label trial, showed that the risk of invasive breast cancer or death was 50% lower with adjuvant trastuzumab emtansine (T-DM1) than with ...
3.1 Trastuzumab is a recombinant humanised monoclonal antibody that specifically targets the HER2 protein. It is licensed for two indications for the treatment of MBC overexpressing HER2 at level 3+.
Genentech announced topline results of EMILIA, a randomized Phase 3 study of trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer. The study showed people who ...
Between July 2001 and November 2004, 41 patients were enrolled in this phase II trial. Patient characteristics are summarized in Table 1. The median age of the entire group was 57 years; 54% of ...
Am J Health Syst Pharm. 2006;63(6):527-533. All women had surgery plus adjuvant or neoadjuvant chemotherapy and possibly radiation therapy before randomization. This trial was less rigorous than ...
The US FDA has notified our partner Mylan that they will extend the target action date for their Trastuzumab 351(k) application to Dec 3, 2017 in order to review some of the clarificatory ...
They add: "There are also problems with affordability. Patients in the ToGA study were treated with trastuzumab every 3 weeks until disease progression. The median time to progression was 6-7 months.
Patients treated with trastuzumab deruxtecan + pertuzumab had a statistically significant and clinically meaningful improvement in PFS compared with standard of care. Topline results were ...