Local Cancer Center first to enroll patient in global, phase III clinical trial

A new Pfitzer drug against breast cancer is currently being tested in international clinical trials, and Cancer Centers of Southwest Oklahoma is the first to enroll a patient in phase III in the entire United States.

Veritac-2 is a global, randomized phase III study of ARV-471, a newly developed oral medication that works by blocking estrogen receptors in patients. Although there are different types of breast cancer, in a majority of them, estrogen is part of the cause, Dr. Eugenio Najera, M.D., principal research investigator at Cancer Centers of Southwest Oklahoma, said.

Dr. Najera, who is board certified in internal medicine, hematology and medical oncology, said that the drug could work for the types of breast cancers that are hormone-positive.

“What we can say is that the medication looks promising,” he said, adding that it “needs to be tested in a larger trial.”

If successful, Dr. Najera said, it would provide a new option for breast cancer patients. Although the drug is currently tested as a single agent, future trials could potentially explore the option of combining ARV-471 with other medications.

While phase I and II of clinical trials focus more on finding safe dosages and finding out about the precise activity of the drug, phase III is the most evidence-based trial, according to Dr. Najera. With ARV-471 now in phase III, researchers can look closer on how the drug fares compared to the current standard medication fulvestrant. One of the big differences is that while fulvestrant has to be injected, ARV-471 is a pill.

Many hospitals and cancer specialists around the world take part in the trials, among others the University of Texas, Florida Cancer Specialists and many more. In Oklahoma, St. Anthony Hospital takes part in the trials, as well. Cancer Centers of Southwest Oklahoma was the first one to enroll a patient in phase III.

“It feels very rewarding,” Dr. Najera said. “We are able to offer our rural patients the chance of a state-of-the-art cancer trial. They don’t have to go to a big city.”

Dr. Najera encourages cancer patients to take part in clinical trials.

“It helps the fight against cancer,” he said. “I’m very grateful for everybody participating in the trials.”

Although it is too early to talk about specific side effects of the newly developed drug, Dr. Najera expects general side effects due to a lack of estrogen. This can include hot flashes, fatigue and joint pain, he said.