Quantum Leap Healthcare Collaborative (QLHC) announced that a new randomized, investigational treatment arm for the I-SPY 2 TRIAL includes the study of olaparib and durvalumab, two agents from AstraZeneca.
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Olaparib is a poly (ADP-ribose) polymerase (PARP) enzyme inhibitor and durvalumab is an anti-PD-L1 monoclonal antibody immunotherapy agent. Olaparib and durvalumab in combination with paclitaxel (chemotherapy) treatment will be compared to standard therapy (paclitaxel) alone in the new I-SPY 2 TRIAL treatment arm. Patients with HER2 negative breast cancer who are eligible to participate in the trial will be adaptively randomized into the olaparib/durvalumab/paclitaxel arm, another investigational arm, or standard of care (paclitaxel). Patients will then continue treatment with doxorubicin/cyclophosphamide (AC) regardless of assigned arm, all taking place in the neoadjuvant setting (treatment and/or chemotherapy prior to surgery).
The I-SPY 2 TRIAL, sponsored by QLHC, is a standing phase 2 randomized, controlled, multicenter study with an innovative Bayesian adaptive design aimed to rapidly screen and identify promising new treatments in specific subgroups of women with newly-diagnosed, high-risk (high likelihood of recurrence), locally-advanced breast cancer (Stage II/III).