Dr Nanda on the Phase 2 I-SPY 2 Trial in Breast Cancer

“It's exciting to think about how we can accelerate the results of these trials and lead to improved outcomes for patients in a short amount of time.”

Rita Nanda, MD, the director of the Breast Oncology Programs and an associate professor of medicine at UChicago Medicine, discussed phase 2 I-SPY 2 trial (NCT01042379) evaluating novel drugs in sequence with standard chemotherapy for the treatment of patients with breast cancer.

The goal of I-SPY 2 is to identify new therapies that are effective for the treatment of patients with breast cancer and subsequently advanced them into large, randomized phase 3 trials, Nanda began. This design allows for effective therapies to be accessed more quickly by patients, she emphasized. The study is enrolling patients with stage II or III disease who area at a high risk of disease recurrence, she added.

I-SPY 2 is adaptively randomized and aims to characterize what type of breast cancer a patient has via molecular testing and match patients with a suitable therapy, Nanda said. As the trial has continued to evolve, regimens graduate into phase 3 evaluation and some therapies have received accelerated approval from the FDA, she noted. One example of this was the FDA approval of pembrolizumab (Keytruda) in combination with chemotherapy for high-risk, early-stage, triple-negative breast cancer, Nanda said. It is exciting for investigators and patients that clinical trial results can be accelerated in this manner and produce improved outcomes for patients in a short amount of time.

Other agents that have been evaluated as part of the ISPY-2 protocol include pertuzumab (Perjeta), trastuzumab (Herceptin), neratinib (Nerlynx), durvalumab (Imfinzi) plus olaparib (Lynparza), cemiplimab-rwlc (Libtayo), and datopotamab deruxtecan-dlnk (Datroway), in addition to several other novel agents and combination regimens. The primary end point of the study is pathological complete response rate. Secondary end points included 3- and 5-year overall survival and relapse-free survival rates, as well as safety.