Oral Paclitaxel combination regimen has graduated from this Phase 2 trial in the triple negative breast cancer subgroup
SAN FRANCISCO, Dec. 20, 2022 /PRNewswire/ -- Quantum Leap Healthcare Collaborative (QLHC) today announced that a regimen including oral paclitaxel plus encequidar (Athenex) in combination with a PD-1 inhibitor and carboplatin has graduated in the triple-negative subset of high-risk early-stage breast cancer. The oral paclitaxel, relative to intravenous paclitaxel, was associated with less neuropathy and was not associated with an increase in febrile neutropenia. We anticipate that these results will be presented at upcoming national meetings in Q2 of 2023.
"It is important for us to seek out optimal combinations of therapies and find ways to reduce toxicity. We are excited to continue working on this and other combinations," said Laura Esserman, MD, the lead investigator for the I-SPY 2 study and founder of QLHC.
The I-SPY 2 TRIAL, sponsored by QLHC, is a standing Phase 2 randomized, controlled, multicenter platform with an innovative Bayesian adaptive randomization design aimed to rapidly screen and identify promising new treatments in specific subgroups of adults with newly-diagnosed, high-risk (high likelihood of recurrence), locally-advanced breast cancer (Stage 2/3) based on molecule characteristics (biomarker signatures). The biomarker rich I SPY 2 TRIAL will continue to investigate the personalized combination of agents to optimize efficacy and toxicity.
Quantum Leap Healthcare Collaborative is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients and researchers. Our goal is to improve and save lives. Quantum Leap provides operational, financial, and regulatory oversight to I-SPY. For more information, visit https://www.quantumleaphealth.org/.
The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2) (I-SPY 2 TRIAL) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 16 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.ispytrials.org.
SOURCE Quantum Leap Healthcare Collaborative