A first-of-its-kind, federally funded clinical trial has shown it’s possible to identify breast cancer survivors who are at higher risk of their cancer coming back due to the presence of dormant cancer cells and to effectively treat these cells with repurposed, existing drugs.
The research, led by scientists from the Abramson Cancer Center of the University of Pennsylvania and Penn’s Perelman School of Medicine, was published in Nature Medicine.
While breast cancer survival continues to improve, when it returns after treatment, it is still incurable. About 30% of patients relapse, and their only option is ongoing treatment that cannot fully eliminate the cancer.
Some cancers like triple negative and HER2+ come back quickly, while ER+ cancers can return even decades later. Until now, there was no way to detect and treat dormant cells that can lead to recurrence.
In a randomized Phase II clinical trial with 51 survivors, existing FDA-approved drugs were used to target these hidden cancer cells. Dormant tumor cells were cleared in 80% of participants. The three-year survival rate without recurrence was above 90% for those treated with one drug and 100% for those who received both drugs.
“These results are very promising,” said lead researcher Dr. Angela DeMichele. “The fear of recurrence is real, and our study offers a potential way to prevent it by targeting hidden cancer cells before they reawaken.”
Dormant cancer cells, also called minimal residual disease (MRD), can’t be seen on scans and may reactivate later, causing metastatic cancer. The study builds on previous research by Dr. Lewis Chodosh, who discovered key biological pathways that help these sleeper cells survive.
The researchers found that two drugs targeting autophagy and mTOR signaling—both critical for cell survival—could eliminate dormant cells in mice.
In the CLEVER trial, patients with dormant tumor cells identified in their bone marrow were given either one or both drugs in six treatment cycles. Most patients cleared the tumor cells within 6 to 12 months, and only two had a recurrence after 42 months.
This strategy of treating cancer during the dormant phase, when it’s not yet aggressive or spreading, may change how breast cancer survivors are monitored and treated in the future.
New trials, including ABBY and PALAVY, are already underway to confirm these results and make this approach available to more patients.
The hope is to give survivors a better option than just “wait and see.”
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The study is published in Nature Medicine.
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