OHC Clinical Trial Impacts FDA Approval of Promising Therapy for Aggressive Breast Cancer

From OHC, Specialists in the Treatment of Adult Cancers and Blood Disorders

September 28, 2021

Patrick J. Ward, MD, PhD, a medical oncologist at OHC

With an enduring interest in offering hope to patients with aggressive cancers, OHC participated in a clinical trial that recently resulted in the FDA approval of a new breast cancer treatment. To help develop new treatment options for triple-negative breast cancer (TNBC), OHC participated in the KEYNOTE-522 trial investigating the use of Keytruda (pembrolizumab) plus chemotherapy versus chemotherapy alone for the treatment of this life-threatening disease. On July 26, the FDA approved Keytruda for high-risk early-stage TNBC in combination with chemotherapy. OHC, one of only two study sites in Cincinnati, treated 10 of the 1,174 patients enrolled in the trial worldwide.

TNBC is a cancer that tests negative for estrogen receptors, progesterone receptors, and HER2 protein; therefore, it will not respond to hormonal therapies or medicines that target HER2 protein receptors. It is often more aggressive and has a bleaker prognosis than other types of breast cancer.

So, when OHC patient Madeline Gillotte was diagnosed with TNBC in March of 2018, she was willing to try anything to get rid of her cancer. To read our October 2019 story on Madeline, follow this link.

“After meeting Madeline and learning more about her disease, I didn’t hesitate to recommend the KEYNOTE-522 trial for her,” said Madeline’s OHC doctor and principal investigator on the study, Patrick J. Ward, MD, PhD, a medical oncologist. “Data from an earlier study showed that the regimen had impressive results. Madeline was willing to enroll right away.”

Keytruda is an immunotherapy that increases the immune system’s ability to detect and fight tumor cells. “I would try anything to save my life, and I hoped I could help others along the way,” said Madeline. She quickly began treatment in April 2018 and had a mastectomy that October. She completed therapy in May 2019 and her pathology was clear. Little did she know that in just over two years she would play a part in bringing her life-saving therapy to others across the country.

“This Keytruda combination is the first immunotherapy regimen approved for high-risk early-stage TNBC,” said Dr. Ward. “The FDA approval is life-changing for women diagnosed with this devastating disease that often spreads or returns after treatment.”

Madeline, a Pleasant Ridge resident, is a soft-spoken pre-kindergarten teacher with a selfless nature. She will positively impact the lives of others through her participation in KEYNOTE-522 and her involvement in the breast cancer and young adult support groups at Cancer Support Community. She does not show any signs of her cancer recurring. “There are no words to describe what OHC means to me,” said Madeline. “They were there for me every week getting me through it and offering support. I love Dr. Ward and all the nurses. They saved my life.”

Next month is Breast Cancer Awareness Month. To learn more about breast cancer, including screening guidelines and treatment advances, call 1-888-649-4800 or visit ohcare.com.

Top picture: Madeline Gillotte snuggles with one of her adopted “COVID kittens.”