Rethinking Patient Selection Strategy for Phase 1 Breast Cancer Trials

In an interview with CancerNetwork®, Oana Danciu, MD, discussed how the profile of patients with breast cancer entering phase 1 clinical trials has changed in recent years. Traditionally, patients enrolled in phase 1 studies only after exhausting multiple lines of therapy. As the number of available agents for breast cancer has grown, including antibody-drug conjugates and newer targeted therapies, waiting until standard options run out risks leaving patients with fewer opportunities to access investigational agents.

Danciu explained that investigators are now bringing phase 1 trials earlier in the disease course. This approach requires strategic patient selection. Because phase 1 trials primarily assess safety, ideal candidates have relatively stable disease that allows enough time on study to evaluate how they respond to a new agent. Patients with rapidly progressing tumors are generally less suitable.

Danciu is associate director of clinical research at the University of Illinois Cancer Center, professor in the Division of Hematology and Oncology at the University of Illinois College of Medicine Chicago, and steering committee chair of the Big Ten Cancer Research Consortium.

Transcript:

Phase 1 trial participants come with very selective characteristics. Traditionally, patients participate in phase 1 clinical trials after they have gone through multiple lines of therapy and reach a point where standard of care is no longer available.

What we have seen in the breast cancer space, and in many other disease sites, is tremendous growth in new agents available for our patients. With that, we have so many lines of treatment for patients with breast cancer. If we stick with the traditional approach of enrolling patients in phase 1 studies after multiple lines of treatment, we risk not being able to offer those trials to our patients.

A strategy for enrolling patients in phase 1 trials is to look at their disease characteristics. Ideal patients for phase 1 trials are those with longer stability of their disease. Patients whose tumors are growing or progressing rapidly are generally not great candidates for phase 1 trials. Ideally, you want someone who has time on study so you can see how they react to these new agents. Phase 1 trials are looking at safety, and to do that, you need some stability in their disease.

What has changed is that we are bringing phase 1 trials earlier in the course of treatment for our patients because we need to maximize our chance to look at investigational agents earlier on vs waiting until late stages of the disease. That requires a strategic approach to enrolling and selecting patients for phase 1 trials.