Sharp HealthCare actively takes part in clinical trials to offer patients new, improved treatments. One such investigational therapy — a new treatment for breast cancer — recently gained U.S. Food and Drug Administration (FDA) approval after showing remarkable benefits for patients with the disease.
Several Sharp HealthCare patients participated in the clinical trial, which showed so much promise in reducing tumors that the FDA deemed the new drug a “breakthrough therapy” during initial phases of the trial.
ENHERTU®, known during the trial as DS-8201, treats patients with a particular type of advanced, aggressive breast cancer. Breast cancer cells in these patients have a gene mutation that makes an excess of a protein called HER2 (human epidermal growth factor receptor 2), which promotes the growth of cancer cells.
About 1 in every 5 women with breast cancer has a type that is HER2-positive. Many of these tumors advance to a point where available therapies can no longer control the disease. The cancer often spreads to other parts of the body.
ENHERTU® is part of a novel class of drugs called antibody-drug conjugates. (Antibodies are proteins made by the body that fight off foreign substances.) The treatment works by attaching chemotherapy to an antibody designed to only bond to cells containing the HER2 protein. Once the drug combination attaches to a breast cancer cell, the chemotherapy is released inside the cell to kill it.
This type of targeted treatment may also reduce the side effects from traditional chemotherapy that can affect both cancerous and noncancerous cells.
“This is a very promising therapy for patients with this type of breast cancer,” says Dr. Charles Redfern, a medical oncologist at Sharp Memorial Hospital and a clinical investigator on the trial. “It has shown an impressive response rate in patients that had an average of seven previous treatments for advanced disease.”
Britta Knight was one such patient who benefited from the treatment. Knight was just 33 years old when she found out she had stage 4 breast cancer in December 2015.
“It started with pain in my left breast that definitely didn’t feel right. It felt like someone was sticking pins and needles in my breast,” says Britta, who is being treated by Dr. Reema Batra, a medical oncologist at Sharp Grossmont Hospital and one of the other clinical investigators.
“Breast cancer can happen at any age, but fewer than 10% of women are diagnosed in their 30s,” says Dr. Batra. “In those instances, the disease is more likely late-stage and tends to be more aggressive.” After meeting specific criteria and exhausting other existing therapies, Britta began her clinical trial in March 2018.
“Dr. Batra was my ally. She sat down with the tumor board and told them about me, and that’s how I got started,” she says.
The treatment was effective, with few side effects, and Britta’s cancer is now in remission. Her scans have shown no sign that the cancer has spread, and she’s maintaining a high quality of life.
“When they brought the idea of a clinical trial to me, I said ‘Let’s do it!’ I thought the worse that could happen is that it wouldn’t work,” she says. “But it has, and I feel like I’m part of something bigger that’s going to make a difference in the lives of women everywhere.”
“Sharp HealthCare was the only health system in the western part of the United States that participated in phase 1 of the clinical trial,” says Dr. Redfern. “Patients traveled from as far away as Canada to participate in the study at Sharp.”
In addition to HER2-positive breast cancer, ENHERTU is being studied in many other cancers with HER2 expression, including lung, colon and stomach cancer.
“It’s OK to be afraid if you have breast cancer, but remain positive and don’t lose hope. There’s so many scientific advances now to help, and I’m grateful to my family and health care team for all the support I’ve received,” says Britta.
Learn more about cancer clinical trials available at Sharp HealthCare.
For the news media: To talk with Dr. Charles Redfern about breast cancer clinical trials or Dr. Reema Batra about breast cancer treatments at Sharp HealthCare for an upcoming story, contact Erica Carlson, senior public relations specialist, at firstname.lastname@example.org.