Believe in Research
Dr. Kelvin Lee, MD
Monogrammed Medicine – our $10 million commitment to genomics research – became a pillar of the Indiana University School of Medicine’s Precision Health Initiative and Indiana University’s first Grand Challenge. This funding launched a research program for women with triple negative breast cancer (TNBC) that the entire university embraced. Now, the concept that therapies can be tailored to treat the most aggressive forms of TNBC is a reality.
Researchers in the Vera Bradley Foundation Center for Breast Cancer Research continue to improve the cure rate for women with the highest risk for recurrence of TNBC. Research builds on the highly successful Monogrammed Medicine program to develop better, more personalized therapies.
Monogrammed Medicine is proving that targeting triple negative breast cancer’s unique genetic vulnerabilities works.
Women with TNBC at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center were the first in the world to receive a unique two-drug combination therapy. The discovery of this aggressive cancer’s genes in the Vera Bradley Foundation Center, also revealed that when the dominant gene was blocked with a targeted drug, the tumor adapted by creating a second line of defense: a reactionary gene that spurred the tumor’s continued growth. A second drug was then identified to block this real-time adaptation. At the time, both drugs were in early development.
While the Monogrammed Medicine research team led the laboratory effort, Kathy Miller, MD, a researcher in the Vera Bradley Foundation Center, developed and directed the Phase I clinical trial, a necessary first step that evaluates the safety of the drug and determines an appropriate dosage. The trial proved to have the second highest success rate nationally of any clinical trial therapy for advanced TNBC.
A large percentage of TNBC patients are now freed from fear of recurrence: Monogrammed Medicine research has identified those most likely to relapse, liberating others to reclaim their lives.
Dr. Bryan Schneider, MD
A national, clinical trial targeting women at high risk for recurrence of TNBC, funded in part by the money we’ve raised and and directed by Bryan Schneider, MD, a researcher at the Vera Bradley Foundation Center, compared precision-guided therapy versus the wait-and-see if TNBC returns before starting treatment approach, the current standard of care.
Blood draws were a component of the trial and the source of an amazing discovery. In this high-risk group of patients, the Monogrammed Medicine team identified critical indicators for who would likely recur and for those who had been cured with initial treatment. Their results were published in the prestigious journal, JAMA Oncology.
By raising awareness of this unique trial through the Vera Bradley Foundation’s our social media, the team doubled its patient enrollment rate and shaved two years off the clinical trial timeline. This allowed many women to reclaim their lives without fear of a cancer recurrence, while intensifying research for those with the most aggressive TNBC.
The results of these two research projects, along with the addition of emerging technologies, are propelling research and new treatment opportunities for women with TNBC.
Components of both Dr. Miller and Dr. Schneider’s Phase I clinical trials will be integrated into Phase II trials beginning in 2022. In the new trial, patients at high risk for recurrence and patients with early-stage TNBC will receive advanced, genomically directed drugs to target TNBC’s most active genes.
In the Vera Bradley Foundation Center for Breast Cancer Research, the design for an entirely new approach to treat triple negative breast cancer is taking shape: Immunotherapy – harnessing innate disease-destroying abilities – for triple negative breast cancer.
Understanding why the immune system fails to stop TNBC is the first challenge. The immune system is the body’s natural defense against disease. While research in this area is 200 years old, it has only been in the last 15 years that scientists have been able to reveal the mechanisms that cancers employ to evade immunity. Now, effective treatments have been developed for some cancers that harness natural immunity to stop the disease process.
First, researchers discovered molecular “checkpoints” that naturally control immune system functions. For instance, immunity is suppressed during pregnancy to protect unrecognizable fetal cells. Checkpoints also manage how the immune system heals a wound or makes a cold go away; likewise, checkpoints also tell the immune system to stop the healing process once recovery is complete. Research is revealing how malignant cells highjack these checkpoints, allowing cancer to develop unchecked.
“Research is where hope lives.”
Dr. Kelvin Lee, MD
The second discovery is that T cells – which the immune system unleashes to seek and destroy abnormal or foreign cells – can be harvested from patients and re-engineered to become targeted cancer treatments. “We can now take the immune system cells and manipulate them with a synthetic process to make cells that redirect the immune system to cure cancer,” explained Kelvin Lee, MD, Director of the Indiana University Melvin and Bren Simon Comprehensive Cancer Center.
“The beauty of immunotherapy – unlike chemotherapy – is that it is a living drug. Using re-engineered T cells to treat cancer has fundamentally changed outcomes for leukemia and multiple myeloma patients,” he continued. “These blood-based cancers are quite different from solid tumors, like breast cancer, but there is a very robust effort at IU to grow this kind of immunotherapy expertise in general for solid tumors and, in particular, for breast cancer.”
Chemotherapy kills cancer quickly and then dissipates from the body. T cells live on providing active surveillance to eliminate recurrent cancer cells should they form. For triple negative breast cancer patients, the combination of immunotherapy with targeted chemotherapy (Monogrammed Medicine) offers the promise of effective treatment and sustained remission.
Lee – who has dedicated his career to developing immunotherapy to treat cancer – believes in this research.
“Nobody believed 20 years ago that immunotherapy would be central to curing cancer. We’re not there yet with breast cancer, but we’re on our way.”