There is a new strategy for treating metastatic breast cancer (MBC), also known as stage 4. This is the most advanced stage of breast cancer. At this stage, cancer cells have spread beyond the breast and nearby lymph nodes to other parts of the body including the bones, liver, lungs or brain. For an estimated 170,000 people in the U.S. who are living with MBC, the disease is not curable today, but it can be treated.
For many people who are living with MBC, initial treatments are effective at first, but cancer cells eventually learn to evolve and resist these drugs. Drug-resistant cancer cells are responsible for a vast majority of breast cancer deaths today. This is why it is critical that researchers gain a better understanding of recurrence and drug resistance in breast cancer, so they can help develop new treatment strategies that will help slow, stop and prevent its progression.
A Moving Target
One of the biggest challenges in treating MBC is that tumor cells can develop characteristics that allow them to resist treatments that were once effective. Some may even change their unique biological signals, or biomarkers, making them harder to recognize and treat with the same therapy. Doctors are often eluded by this “moving target,” and treatments are based on a patient’s initial biopsy. But how can doctors make treatment decisions based on what a tumor is doing today if they only have information about it from several months ago?
This question is at the center of the Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (EVOLVE-BDT) clinical trial, a new study that uses real-time monitoring to track how each person’s cancer changes over time, and ultimately, to find the best match for treatment. Researchers hope this more personalized approach will help break through the barrier of drug resistance and improve survival and quality of life for the MBC community.
The EVOLVE-BDT Clinical Trial
The EVOLVE-BDT clinical trial is investigating a new treatment approach for people with either metastatic estrogen receptor-positive (ER+)/HER2-negative (HER2-) breast cancer or metastatic triple negative breast cancer (TNBC). Eligible study participants must have one of these cancer types and experienced progression on their first treatment after an MBC diagnosis but not yet started a second treatment.
For this study, instead of having a predetermined treatment group, or “arm,” participants are divided into different treatment arms based on the unique response of each tumor. To track how these tumors change over time, researchers will collect information from participants including blood tests, tumor biopsies and detailed imaging.
They will also study circulating biomarkers and circulating tumor DNA (ctDNA) and watch closely for any signs of treatment resistance. This method allows researchers to test multiple targeted drugs at the same time and provide participants with different treatments if their cancer progresses.
EVOLVE-BDT is led by Lisa Carey, M.D., at UNC Lineberger Comprehensive Cancer Center, and includes principal investigators from several other institutions, including Yale Cancer Center and Johns Hopkins Kimmel Comprehensive Cancer Center. EVOLVE-BDT is part of a larger program called ADAPT (Advanced Analysis for Precision Cancer Therapy), which is an initiative to shift cancer treatments from a one-time intervention to a real-time method of tracking and effectively targeting evolving tumors.
Like other studies in the ADAPT program, EVOLVE-BDT represents a breakthrough in how cancer cells can be treated. Real-time monitoring of MBC may help doctors act earlier, modifying or changing treatments when signs of resistance begin to appear, rather than waiting until symptoms return or the tumor progresses. Researchers can also use information like biomarkers to build computational models that predict the future behavior of tumor cells. This information could help doctors and patients stay one step ahead of MBC, creating a proactive treatment plan before a tumor has a chance to grow and spread.
A Hopeful Shift for Patients
For people living with MBC, the promise of the EVOLVE-BDT clinical trial is not only scientific, but also personal. No two tumors are exactly alike, and by using each person’s unique biology as a guide, doctors may be able to better match patients with more effective therapies and avoid keeping them on treatments that are no longer working for them.
Beyond the benefits of better treatments, this approach could mean a number of other significant improvements for patients, including quicker interventions and significant out-of-pocket savings. Even on a psychological level, staying one step ahead of the disease could give patients and their loved ones a sense that they are in control.
The long-term goal of the EVOLVE-BDT clinical trial is to give people with MBC the gift of more time and the best possible quality of life. Positive results from EVOLVE-BDT could mean a future shift in how we see MBC, from a once terminal diagnosis to a manageable, treatable long-term condition.
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Learn more about Komen’s resources for those living with MBC
Learn more about the EVOLVE-BDT clinical trial
Explore the trial fact sheet
