Clinical trial assesses de-escalation of chemotherapy for triple-negative breast cancer

Advocate Health Care and Aurora Health Care community cancer clinics will compare shorter, anthracycline-free chemotherapy to the current standard of care

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Clinical trial assesses de-escalation of chemotherapy for triple-negative breast cancer

Advocate Health Care in Illinois and Aurora Health Care in Wisconsin have joined a clinical trial evaluating whether a shorter chemo-immunotherapy regimen that uses fewer drugs works as well as the standard treatment for people with early-stage triple-negative breast cancer.

Triple-negative breast cancer accounts for between 10% and 15% of all breast cancers. The foundation of treatment is chemotherapy, and hormone therapy is not an option.

“The current standard of care for people with stage 2 triple-negative breast cancer is eight cycles of chemotherapy with immunotherapy, followed by surgery and then additional immunotherapy,” said oncologist Thomas Saphner, MD, Advocate Aurora Research Institute’s principal investigator for the study. “The purpose of this study is to determine if a cardiotoxic drug, doxorubicin, can be removed from the regimen and if six cycles of treatment are as good as eight cycles.”

“The current eight-cycle regimen is effective but long and cardiotoxic, meaning it can have harmful effects on the heart,” said Melissa Kadar, Director of the Research Institute’s Center of Excellence in Cancer Research. “This is why it’s important for researchers to make efficacious treatment less toxic. If two treatments are equal in results but one regimen is less toxic, that is an improvement in care.”

There is evidence from prior studies of adjuvant therapy that shorter courses of chemotherapy are identical in efficacy to longer regimens. If a patient is cured with six cycles of chemotherapy, there is nothing to gain from additional treatment.

The clinical trial, which is open at Advocate and Aurora cancer clinics in communities across both states, will enroll 2,400 participants at sites throughout the country.

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.

The study, “Shorter anthracycline-free chemo immunotherapy adapted to pathological response in early triple negative breast cancer (SCARLET), a randomized phase III study,” or S2212, is led by SWOG Cancer Research Network, a cooperative research group that designs and conducts clinical trials under the sponsorship of NCI.

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About Advocate Aurora Research Institute

Advocate Aurora Research Institute is a not-for-profit, limited liability company of Advocate Aurora Health. Advocate Aurora has emerged as a national destination for patient-centered bench, translational and clinical research, and the Research Institute unifies the innovative research efforts throughout the health system. Advocate Aurora researchers focus on rapidly translating new discoveries from the scientist’s bench to the patient’s bedside and into the community we serve to improve options and outcomes that change not only the lives of individuals, but transform the health of populations.