Evolutionary Clinical Trial to Identify Novel Biomarker-Driven Therapies for Metastatic Breast Cancer

Metastatic breast cancer, which occurs when cancer spreads from the breast to other parts of the body, is one of the most difficult cancers to treat. Nearly 90% of patients with metastatic cancer will eventually develop resistance to therapy, making it challenging to achieve lasting treatment responses. Between 20% and 30% of individuals with early-stage breast cancer will develop metastatic cancer over time. Despite progress in the past few decades, curative therapies for metastatic breast cancer are still lacking. Now, a new clinical trial aims to track cancer biomarkers in real time to enable the prediction of metastasis and adapt treatment plans based on how the tumor evolves. This approach hopes to improve treatment outcomes by better tailoring therapies to each patient as their cancer progresses.

The Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (EVOLVE), co-led by researchers at Yale Cancer Center (New Haven, CT, USA), will enroll up to 700 patients with metastatic breast cancer across 15 institutions, including those from the Translational Breast Cancer Research Consortium (TBCRC). The EVOLVE trial will incorporate real-time biomarker data—such as fragments of tumor DNA circulating in the blood—to monitor tumor changes and inform therapy decisions. This data-driven approach aims to adapt treatment strategies as tumors evolve, providing a more personalized treatment experience. EVOLVE will also investigate biomarkers that could predict the likelihood of metastasis, which is a major hurdle in understanding cancer progression.

The trial is part of a larger initiative supported by an up to USD 28 million grant from the Advanced Research Projects Agency for Health (ARPA-H), which is dedicated to advancing precision cancer therapy. The study will build upon previous work in the TBCRC, which has already made progress in leveraging large data sets to identify biomarkers. The trial's results could significantly impact how treatment strategies are developed and refined, providing insights into the mechanisms of treatment resistance. Researchers plan to use these findings to enhance the design of future cancer therapies, with the ultimate goal of improving survival rates for metastatic breast cancer patients. EVOLVE’s real-time monitoring system may lead to more effective treatments by continuously adjusting care as the cancer progresses.

“Collecting and analyzing biospecimens to develop, validate, and test biomarkers and pair them with the proper therapy is critical,” said Ian Krop, MD, PhD, one of the principal investigators of the study. “We can maximize the impact of the next generation of cancer-fighting drugs when we use the results from clinical trials to inform how the therapies can be refined to benefit the most patients.”

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