FDA approval of drug regimen helps lower recurrence risk for early-stage breast cancer patients

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Two-time breast cancer survivor Teri Boudreaux is grateful for the time she gets to spend with her family, whether traveling with her husband, playing with her grandchildren, hiking, relaxing on the beach, or picking up new hobbies such as pickleball.

Yet, a persistent fear lingers in the back of her mind: the possibility of the cancer coming back. “I think what a lot of us survivors are most afraid of is recurrence of breast cancer,” Boudreaux said. “It’s a lifelong concern.”

She was first diagnosed with triple-negative breast cancer in 1990, when she was 38 years old. Following treatment, she was cancer-free for nearly two decades. Then in 2017, Boudreaux tested positive for the BRCA gene. She also noticed a lump in her breast during a self-check and was diagnosed with hormone-receptor (HR) positive/HER2 negative breast cancer, the most common subtype of the disease.

Current treatment includes endocrine therapy, which blocks or lowers the levels of estrogen production so cancer cells can’t use it to grow and spread. But stage 2 and stage 3 patients still face a 27% to 57% risk of the disease coming back years after the initial diagnosis.

Dr. Rena Callahan, an associate clinical professor of medicine at the David Geffen School of Medicine at UCLA, suggested Boudreaux join a clinical trial studying the benefit of adding ribociclib to conventional hormonal therapy. Ribociclib works by blocking the activity of certain enzymes that promote cell division and cancer growth.

Earlier research from a team headed by Dr. Dennis Slamon, chair of hematology-oncology at the Geffen School of Medicine and director of clinical and translational research at the UCLA Health Jonsson Comprehensive Cancer Center, helped lead to Food and Drug Administration approval of ribociclib and related drugs to treat advanced metastatic breast cancer.

NATALEE, the new clinical trial built on this research. The results of the study, published in the New England Journal of Medicine in March, showed the addition of the drug with endocrine therapy significantly extended how long people with this type of early breast cancer live without the cancer returning.

On Sept. 17, the FDA approved the use of ribociclib in combination with hormonal therapy to treat HR-positive, HER2-negative early-stage breast cancer.