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A multidisciplinary team of researchers at VCU Massey Comprehensive Cancer Center and MD Anderson Cancer Center has been awarded a $7.3 million grant from the U.S. Department of Defense to fund a novel clinical trial targeting one of the most aggressive and hard-to-treat forms of breast cancer: metastatic triple-negative breast cancer (TNBC). The study marks a significant step toward transforming treatment regimens and improving outcomes for patients with metastatic TNBC.

Vekata Lokesh Battula, Ph.D., who recently joined Massey as its assistant director of Cancer Research Training and Education Coordination (CRTEC) Efforts and professor in the Department of Internal Medicine at the VCU School of Medicine, led the preclinical studies at The University of Texas MD Anderson Cancer Center in Houston that provided the basis for the grant and clinical trial. Pictured: Venkata Battula, Ph.D., assistant director of Cancer Research Training and Education Coordination Efforts (CRTEC)

“I look forward to successful outcomes from this trial, especially because we try to eliminate the cells that are the root cause of the origin of cancer and its spread in patients with TNBC,” Battula said.

Battula’s work at MD Anderson helped identify a new marker in patients with TNBC called GD2, which is expressed on cancer stem cells that contribute to cell proliferation and metastasis and correlate with worse patient outcomes.

The trial (NCT07011654) will test the safety and efficacy of combining two therapies – naxitamab, a targeted antibody therapy directed against GD2, and sacituzumab govitecan, an FDA-approved chemotherapy-based treatment used in metastatic TNBC. If successful, this study will be the first to overcome TNBC’s resistance to sacituzumab govitecan by eliminating breast cancer stem cells, potentially paving the way for more durable responses in patients with metastatic TNBC.

“We have found that GD2, a surface marker, is overexpressed in more than half of TNBC tumors. Our data indicate that GD2-expressing TNBC cells could be targeted using anti-GD2 monoclonal antibodies. Our studies have identified a novel therapeutic strategy to identify and eliminate these treatment-resistant cancer stem cells,” Battula said. “In targeting GD2 with naxitamab, we are hoping to eradicate the root cause of resistance and boost the long-term effectiveness of sacituzumab govitecan.”

MD Anderson will open and enroll patients in the clinical trial, with research specimens collected from enrolled patients sent to Battula for analysis to be conducted at VCU. This trial is led by Clinton Yam, M.D., associate professor of Breast Medical Oncology at MD Anderson, along with Battula. This project also benefits from strategic collaborations with the University of Hawai’i Cancer Center and the Houston Methodist Research Institute.

TNBC is an aggressive and heterogeneous type of breast cancer with few therapeutic options due to being resistant to anti-hormone and anti-HER2 therapies, lacking targeted treatment options once it has spread beyond the breast and nearby lymph nodes. One major reason for treatment failure is the persistence of breast cancer stem cells, a rare population of tumor-initiating cells that can survive standard therapies by entering a dormant state. These cells can later re-emerge and drive tumor recurrence.

Written by: Bill Potter