Cancer researchers at Aurora Health Care in Wisconsin and Advocate Health Care in Illinois are enrolling participants in a clinical trial that aims to determine how many months of immunotherapy are necessary to completely eliminate a person’s early-stage breast cancer.
“People diagnosed with early-stage triple-negative breast cancer typically receive chemotherapy in combination with the immunotherapy drug pembrolizumab, followed by surgery and then six more months of pembrolizumab,” said oncologist Thomas Saphner, MD, Advocate Aurora Research Institute’s principal investigator for the clinical trial. “This study asks if patients who achieve a pathologic complete response – meaning there is no residual cancer – from preoperative chemo and pembrolizumab really need more pembrolizumab after surgery.”
The OptimICE-pCR clinical trial (Alliance A012103), which is open at Advocate and Aurora cancer clinics in communities across both states, will evaluate six months of observation without immunotherapy following surgery compared to the standard approach of six additional months of immunotherapy for patients who have no remaining disease after surgery.
Triple-negative breast cancer accounts for approximately 15% of invasive breast cancers.
“Triple negative breast cancer is difficult to treat,” Dr Saphner said. “Treatment commonly incudes chemotherapy. People who achieve a pathologic complete response to neoadjuvant therapy – meaning the treatment before surgery – have a better prognosis.”
“The use of immunotherapy in combination with chemotherapy prior to surgery has increased survival for our patients,” said Melissa Kadar, Director of the Research Institute’s Center of Excellence in Cancer Research. “Studies demonstrated that the addition of immunotherapy before and after surgery decreases recurrence, but it is not known if the addition of immunotherapy is necessary in patients who achieve a complete response to neoadjuvant therapy. Aurora and Advocate are proud to support clinical research like this that has the potential to deescalate cancer therapy, saving our patients from unnecessary treatment side effects and costs.”
The Research Institute is participating in the study through its inclusion in the National Cancer Institute’s (NCI) Community Oncology Research Program (NCORP), which brings cancer clinical trials to people in their own communities instead of only at major research institutions.
Researchers across the country plan to enroll nearly 1,300 participants in the clinical trial, “Pembrolizumab vs. observation in people with triple-negative breast cancer who had a pathologic complete response after chemotherapy plus pembrolizumab.”
The nationwide study (clinicaltrials.gov Identifier: NCT05812807) is led by Alliance for Clinical Trials in Oncology, a cooperative research group that designs and conducts clinical trials sponsored by NCI.
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