Delphi Diagnostics on Thursday announced the inclusion of the firm’s SET2,3 test in the ongoing I-SPY 2 trial for patients with locally advanced breast cancer.
The I-SPY 2 trial, sponsored by Quantum Leap Healthcare, is designed for rapid Phase 2 assessment and personalized targeting of treatment agents or combinations based on biomarker subtypes defined by hormone receptor, HER2, and tumor gene signature status.
While the test has been used to assess tumors in the ongoing trial for the past year, it will now additionally be used for adaptive randomization of patients whose biomarker profiles (including SET2,3 test data) show that they may benefit from endocrine therapy rather than chemotherapy. These patients will be given the option to be randomized into an arm of the Endocrine Optimization Pilot (EOP), a subset of the trial.
The EOP will focus on endocrine treatment for patients with molecularly low-risk, clinically high-risk, hormone receptor-positive and HER2-negative breast cancer. Patients who have previously been excluded from the I-SPY 2 trial due to their predicted lack of response to chemotherapy can now be enrolled if their biomarker profiles predict that their tumors may respond to endocrine therapy.
The SET2,3 test index measures levels of transcriptional activity of genes related to receptors for estrogen and progesterone. The index is then adjusted based on the baseline prognosis for the patient, which includes tumor size and lymph node status.
The I-SPY 2 trial is the longest-running platform trial globally; the trial currently has more than 1,400 patients enrolled.