Human epidermal growth factor receptor 2 (HER2) is overexpressed in 20–30% of breast cancer tumours and is associated with a more aggressive type of disease, higher recurrence rate and increased mortality.

Benchmarking Phase II HER2+ breast cancer trials using GlobalData’s Feasibility Planner can give those developing new drugs important timelines to meet or beat. A drug developer should expect a 78.3% likelihood of completion and a 0.47% chance of suspension for these trials. The projected median timelines include 27.4 months for the enrolment period and 41.6 months for total trial duration. Enrolment goals suggest an enrolment rate of 0.3 subjects/sites/month, four sites, and 53 subjects, based on previously completed trials in this indication.

It Is also important to examine why trials failed and to learn from these mistakes. The biggest reason by far for trial termination is low accrual rate (65%), followed by lack of efficacy (13%) and adverse events (8%), as shown in Figure 1. This highlights the importance of selecting a suitable country or countries where you can expect to find an available patient population to run your HER2+ Phase II trial; a study region that isn’t saturated from planned or ongoing trials in this indication.

The selection of sites and investigators with experience and availability to run these trials will also help you avoid a low accrual rate and subsequent higher cost of development. The Feasibility Planner uses different algorithms to best recommend these geographies, investigators, and sites to allow that.

Figure 1: Reasons for termination

Source: GlobalData