We’re proud to be part of the groundbreaking I-SPY2 trial, which looks at whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR)* over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry.
So far, findings support the use of residual cancer burden (RCB)† as a prognostic indicator for 3-year outcomes in patients pre-selected as high risk for recurrence, and the importance of MammaPrint in identifying these patients.
A next-gen adaptive platform
I-SPY2 breaks from the traditional randomized form of trial, employing an ‘adaptive’ model that allows multiple treatments (up to six different agents) to be studied in parallel. This master framework also allows new agents to enter and leave the study without having to halt enrollment or resubmit the entire clinical trial protocol for regulatory review.
I-SPY2’s innovative design sets a new benchmark for efficiency in phase II clinical trials, by minimizing the number of participants and time required to evaluate each experimental agent. Widely regarded as a pioneer of the ‘platform’ trial, I-SPY2 is a major influence on the development of next-generation trial designs in oncology and beyond.
Where to next?
*Pathological complete response (pCR) predicts event-free survival (EFS)‡ and distant recurrence–free survival (DRFS) in the setting of a multiple agent platform trial and enables rapid evaluation of novel therapy combinations and can accelerate the identification of effective and potentially less toxic regimens.
†Residual cancer burden is how much cancer is left after neoadjuvant treatment. Characteristics such as the tumor’s size, histological features, and number of positive lymph nodes are used to determine the residual cancer burden.
‡After primary treatment for a cancer ends, event-free survival (EFS) is achieved when the patient remains free of certain complications or events that the treatment was originally intended to prevent or delay.