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Clear skies. Low 57F. Winds S at 10 to 15 mph..

Clear skies. Low 57F. Winds S at 10 to 15 mph.

When all else fails, Michaela Bertram wants to offer breast cancer patients another medical reason for hope.

Bertram, based in Sioux Falls, serves as the cancer research manager at the Avera Cancer Institute (ACI). Her work includes a HER2-positive breast cancer clinical trial now offered in Yankton.

“This clinical trial is offered as an option after other treatments are considered and failed,” she said. “This (trial) would be in addition to what the patient has already received.”

With October designated as Breast Cancer Awareness Month, the Avera announcement comes at a particularly appropriate time, Bertram said.

Clinical trial participants receive an oral medication, that can be taken at home, with doses twice a day during a three-week cycle. The process can last up to 14 cycles, and the patient must visit the local oncologist on the first day of each cycle.

The Avera Health system conducts extensive cancer research, with the HER2-positive breast cancer trial among the tests, Bertram said.

“In Sioux Falls, we at any given time have around 60 open clinical trials that patients can enroll in,” she said. “We’re opening up other locations so patients can be part of the clinical trials virtually, and we’ve now opened Yankton.”

Clinical trials generally start in Sioux Falls and are then opened to other locations, Bertram said. The HER2 study has been open in Sioux Falls for about a year.

A patient with HER2-positive breast cancer tests positive for a protein called human epidermal growth factor receptor 2 (HER2), according to the Mayo Clinic website. This protein promotes the growth of cancer cells.

“In about 1 of every 5 breast cancers, the cancer cells have extra copies of the gene that makes the HER2 protein. HER2-positive breast cancers tend to be more aggressive than other types of breast cancer,” the site says.

“Treatments that specifically target HER2 are very effective. These treatments are so effective that the prognosis for HER2-positive breast cancer is actually quite good.”

Certain standard chemotherapy drugs also can be effective in treating HER2-positive breast cancers, although these drugs don’t specifically target the HER2 protein, according to the Mayo Clinic.

“Experts recommend that every invasive breast cancer be tested for the presence of HER2 because the results significantly impact treatment recommendations and decisions,” the site says.

Dr. Mary Lee Villanueva, an oncologist at the Yankton Medical Clinic, will work with patients in the clinical trial at the Avera Cancer Institute in Yankton. She will provide on-site treatment and oversight for local patients in the trials as well as the connection with Sioux Falls researchers.

“Dr. Villanueva is part of the team and will notify us in Sioux Falls if they have a patient with a (potentially qualifying) cancer diagnosis in Yankton,” Bertram said. “Our team then pre-screens patients to see if they meet the eligibility criteria.”

Dr. John Lee, the ACI clinical medical officer for cancer research, says Avera is working toward offering the majority of clinical trials at all ACI locations.

“Avera is poised to become well-known and sought after for its cancer services in the region and nation,” he said. “Through research, we’re discovering and developing new avenues of hope for cancer patients and their families.”

Avera’s participation in clinical trials is affiliated with the National Cancer Institute and NRG Oncology.

By offering the HER2-postive clinical trials at Yankton, local patients don’t need to travel about 80-85 miles to Sioux Falls, Bertram said. In turn, family, friends and caregivers don’t need to take extensive time off from work to transport the patient for treatment or appointments in Sioux Falls.

“I can’t say enough how really important that support is,” she said. “It’s not possible all the time for family members or close friends to take the time for access to Sioux Falls, so Avera wanted these trials closer to home.”

The following are steps and criteria for this Avera clinical trial:

• Patients must be diagnosed with HER2 positive breast cancer, have received chemotherapy prior to undergoing surgery and have residual hormone-receptor positive breast cancer after surgery.

• Interested patients would need to review and sign the informed consent with a cancer research coordinator (either in person or virtually). They are made aware of possible side effects.

• The clinical trial offers the patients a chance at receiving standard-of-care treatment versus standard-of-care treatment plus the experimental drug.

• Clinical trials offer patients the chance to receive an experimental drug before it is approved by the Food and Drug Association (FDA). While participating in clinical trials, patients are closely monitored by their oncologist and clinic staff as well as the research coordinators and research pharmacists.  

In terms of covering the treatment expenses, Avera generally bills the patient’s insurance for standard care and assessment, Bertram said. The research-only expenses will not be billed to insurance, as the experimental medicine will be provided free of charge.

By offering the clinical trial in Yankton, patients can consult with a local health professional in tailoring a care plan, Bertram said.

“We want the oncologist to present the patients with their treatment options, including if the clinical trial is open and available,” she said. “The doctor has the opportunity to say, ‘We could offer this standard of care treatment, or we have the clinical trial that’s available.’”

Even if a patient qualifies for the clinical trial, he/she isn’t automatically made part of the program. The patient must sign a letter of informed consent, and the ACI would decide which patients to accept under the randomized clinical trial.

The study can enroll 1,031 patients nationwide, Bertram said. “(Avera) would like to enroll as many as we can until (the NCI) reaches that number,” she said.

A clinical trial participant will receive more than the standard care, not less care or a substitute, Bertram emphasized.

“It’s statistically proven that the patient who participates in clinical trials are more likely to have a 5-10% better outcome because they have so many people monitoring them, including the FDA,” she said.

The patient’s participation in a clinical trial could provide an important step in getting the drug on the market, Bertram said.

“Every drug that is out there has gone through clinical trials before receiving FDA approval,” she said. “This gives patients the opportunity to receive an experimental drug that could receive the next FDA approval; it’s just they’re receiving it before it gets FDA approval.”

Should the clinical trial participant contract COVID, the continuation of the experimental cancer treatment would depend on the patient’s condition, Bertram said.

“If it’s a mild case where the patient for the most part is symptomatic, then treatment for their cancer would continue,” she said. “If it’s severe and they are hospitalized, the chances are their testing will be placed on hold.”

The researchers will monitor not only the patient but the overall success of the clinical trial, Bertram said.

“If we see the clinical trial isn’t successful, at that point in time, we would not ethically enroll them if we knew it wouldn’t work or make a difference,” she said. “But I have been working in cancer research for 11 years, and we have definitely seen success.”

During the past two years, many members of the public have not continued check-ups and screenings because of the pandemic, Bertram said. Health professionals are urging their patients to resume those procedures, she said.

“We think Breast Cancer Awareness Month is every month of the year, but it does provide a good way of promoting it,” she said. “As health care workers, we know the importance of these screenings. Hopefully, just talking about these clinical trials will encourage a person to see a doctor.”

Now, the Avera clinical trials provide another resource close to home for those battling breast cancer, Bertram said.

“We’re ready to go (with the trials),” she said. “Now, all we need are patients.”

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