Dr. Blackwood on the Implementation of the I SPY2 Trial in Breast Cancer

M. Michele Blackwood, MD, FACS, chief, Section Breast Surgery, Rutgers Cancer Institute of New Jersey, professor of Surgery, Rutgers Robert Wood Johnson Medical School, medical director, The Center for Breast Health and Disease Management, the Barnabas Health Ambulatory Care Center, discusses the implementation of the phase 2 I-SPY 2 trial (NCT01042379) in breast cancer at Robert Wood Johnson Medical Center.

The ongoing trial is aiming to determine which new agents are most effective in various types of breast cancer tumors by learning more about which early indicators of response are predictors of treatment success. Investigators are evaluating the efficacy of novel drugs in sequence with standard chemotherapy in order to identify treatment strategies for subsets of patients based on biomarker signatures of their disease with high estimated pathologic complete response rate.

In May through December 2021, investigators at Robert Wood Johnson Medical Center began implementing all of the components necessary to conduct I-SPY 2 by aligning staff on the procedures and goals of the study, conducting proper training, and obtaining the various agents needed for the trial, Blackwood says. This preparation was necessary due to the substantial number of operational pieces needed for this study, and this allowed investigators to enroll their first patient at Robert Wood Johnson Medical Center in January 2022, Blackwood adds.

Upon enrolling this patient and others considered for the trial, their medical information was shared at a multidisciplinary meeting with the rest of the clinical team and trial coordinators. Because patients enrolled on the study have advanced stage II and III breast cancer, investigators aimed to quickly address patients with biopsies, MRIs, and MammaPrint assays, Blackwood continues. By conducting these tests quickly, investigators could limit the time between patient enrollment and the start of treatment, since beginning treatment within the first 2 weeks of enrollment was better for overall patient care, Blackwood explains.

Notably, instead of sending patients for neoadjuvant chemotherapy, surgeons saw the patients on a more frequent basis than usual, with visits occurring at least once a month for several months prior to surgery, Blackwood notes. This allowed patients and their family or caregivers to receive pertinent information and ask questions, Blackwood concludes.