Quantum Leap Healthcare Collaborative presented the progress of the I-SPY 2.2 TRIAL, highlighting its patient-centered approach to treating early-stage breast cancer. The trial aims to improve outcomes and reduce toxicity for patients at high risk of early recurrence.
Aims to Prevent Recurrence
Each year, approximately 78,000 early-stage breast cancer patients face a high risk of recurrence. I-SPY 2.2 aims to prevent recurrence in these patients, effectively offering a potential cure.
Dr. Laura Esserman, founder and Co-Principal Investigator of I-SPY2.2, emphasized the trial's patient-friendly design and its focus on biologically targeted treatments. "Ultimately, the goal is to find and develop biologically targeted treatments that help get each patient to the best possible outcome, with the least toxicity. I firmly believe this trial is going to do just that," she stated.
Innovative Trial Design
I-SPY 2.2 introduces a neoadjuvant approach, administering treatment before surgery. The trial design allows for treatment redirection based on individual patient responses, determined through imaging and biopsy. This adaptive strategy enables escalation to more intensive treatments or de-escalation to avoid unnecessary toxicity.
The trial utilizes a Sequential Multiple Assignment Randomized Trial (SMART) design to individualize care while maintaining the ability to compare different drugs and treatment sequences.
Efficiency and Impact
Dr. Angela M. DeMichele highlighted the trial's efficiency in testing multiple treatments simultaneously. "We can test 5 or more different treatments (or combination of treatments) at once. This allows us to be nimbler in our care of patients and respond to their needs more quickly and efficiently," she explained.
To date, I-SPY 2 has enrolled over 3,000 patients across 43 U.S. sites. Ten drugs have graduated from the trial, with two receiving accelerated approval and one gaining breakthrough designation from the FDA. The trial's design aims to reduce the time and cost of clinical trials, accelerating the availability of effective treatments.
Future Directions
I-SPY2.2 continues to evolve, focusing on patient-reported outcomes to quantify the burden of treatment side effects. The trial is also assessing the value of liquid biopsies to predict outcomes early in treatment.
Anna Barker, Chair of the I-SPY2.2 Oversight Group, noted the trial's influence on other disease areas. "It has already served as the prototype for new adaptive platform trials in pancreas and glioblastoma as well as other diseases such as Alzheimer’s disease...[it] is the best example of precision oncology available today,” she said.
