New mother part of local clinical trial

In December 2018, Kristen Louis, then 30, noticed an unusual dimple in her right breast and subsequently made an appointment with her OB-GYN to get it checked. When the doctor asked if she might be pregnant, she said she didn’t think so but agreed to take a test. Imagine her surprise when that test was positive.

Although her doctor initially thought the dimple and corresponding lump might be related to the changes in her body due to pregnancy, she set Louis up for further testing. After an ultrasound and then a biopsy, it was determined to be cancer.

“Thank God she didn’t just chalk it up to pregnancy,” said Louis, who was nine weeks pregnant at the time her cancer was diagnosed.

After meeting with medical oncologist Stephani Christensen at the Comprehensive Cancer Centers, Louis opted for a lumpectomy and chemotherapy.

“It might seem strange that someone could go through chemo when they’re pregnant,” Louis said, “but I was assured that the chemo wouldn’t pass the placenta.”

Christensen concurs, saying, “The data is pretty robust that giving chemotherapy to pregnant women is safe, and, case in point, she did incredibly well, had almost no side effects, and the baby was born healthy. It was a great situation for everyone.”

Today, Louis has an energetic 13-month old baby boy, and — after two additional lumpectomies that led eventually to a mastectomy and a series of radiation treatments during the beginning of 2020 — she is part of the NATALEE phase III trial. This trial seeks to evaluate the effectiveness and safety of a drug called ribociclib in combination with conventional endocrine therapy for patients with hormone receptor-positive, HER2-negative early breast cancer, the kind Louis had.

“I asked Kristen if she would be interested in participating, just as I ask my other breast cancer patients,” Christensen said. “I’m offering it to anyone that has a moderate or high risk of recurrence so, generally, I discuss it with people that I treat with chemotherapy who have larger tumors, positive lymph nodes or a higher stage breast cancer.

“Kristen had a couple of good things going for her,” she continued. “One was that she did well with chemotherapy so you know she’s going to do well with adjuvant therapy as well. Additionally, she had high-risk disease so my hope is that by adding ribociclib to her adjuvant therapy we may be able to further reduce her risk of breast cancer recurrence.”

International in scope, the NATALEE phase III trial includes 4,000 participants. Of those, Comprehensive Cancer Centers currently has 19 patients enrolled, 11 of whom are patients of Christensen.

“Half of the participants will receive standard of care and the other half will receive the same standard of care plus the drug ribociclib,” she said.

Standard of care, or best practice, is defined as a guideline for the appropriate treatment of a condition as established by experts on that condition. In the context of a clinical trial, such as NATALEE phase III, a patient receiving standard of care will be treated the same way they would for their condition as if they were being treated outside of a clinical trial. The other patients will receive that same standard of care as well as the experimental drug (ribociclib).

“I was able to take the study drug being offered during this trial,” Louis said. “When Dr. Christensen asked me if I wanted to participate, of course, I said yes. I would love to help people who may go through this in the future.”

She began taking the medication in March.

Christensen said that Louis will be on ribociclib for a three-year period, then she’ll continue to receive standard of care and will be tracked during the study’s 10-year time frame.

“It’s great to get people here in the valley on trials because of the potential for benefits for all breast cancer patients, Christensen said. “Comprehensive Cancer Centers is building a research program that all citizens of the valley can benefit from. Typically, people might have to travel to other places to participate in a clinical trial, but we have many like this one that is happening right here in Las Vegas.”

As for Louis, she’s back to her overly busy life but credits Christensen and her other physicians for her vitality.

“I just love all of my doctors,” she said. “Through all of my special circumstances, they made me feel so comfortable and taken care of. ”