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The adaptive I-SPY2 clinical trial of neoadjuvant treatment of breast cancer has established a new benchmark for efficiency in Phase 2 drug development.

I-SPY 2 Framework Could Represent the Future of Drug Development in Breast Cancer ... Traditional paradigms for clinical trials have limited ...

It is a Phase 2 clinical trial that is testing new investigational drugs and combinations of drugs. You receive drug treatment before surgery instead of after ...

VerkkoSummary: I-SPY 2 uses an individualized approach in clinical trial design to improve high-risk breast cancer outcomes. The purpose of this review is to encourage further research …

VerkkoThe Clinical Trial, Re-Imagined. The ground-breaking I-SPY 2 trial of neoadjuvant treatment for locally advanced breast cancer established a new benchmark for efficiency of phase …

I-SPY 2 is a phase 2 signal-finding trial. From a drug development perspective, it was designed for efficiency – to rapidly identify, from among a growing list ...

VerkkoI SPY 2.2 will evolve to a regulatory seamless phase 2/3 design by late 2022. The I-SPY 2.2 Design I-SPY 2 is evolving, in part, due to the success in identifying treatments that …

I-SPY 2 will compare the efficacy of novel drugs in combination with standard chemotherapy with the efficacy of standard therapy alone.

We designed I-SPY 2, a phase 2, multicenter, adaptively randomized trial to screen multiple experimental regimens in combination with standard neoadjuvant chemotherapy for breast cancer.

Dec 20, 2022 · What is I-SPY? The I-SPY series of trials are changing the way new treatments are developed for breast cancer, helping make available new, better and more personalized treatments, faster. At the heart of the I-SPY program is the ground-breaking I-SPY 2 platform trial for neoadjuvant treatment of locally advanced breast cancer. >2500.

How I-SPY 2 Works I-SPY 2 breaks from the traditional randomized clinical trial model, employing an 'adaptive' clinical trial model designed to increase trial efficiency by minimizing the number of participants and time required to evaluated an experimental agent.

The I-SPY 2 breast cancer trials assess activity of new agents by adaptive randomization, applying criteria for success on a surrogate end point to predict success in confirmatory trials.

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Purpose of review: The I-SPY 2 trial is an adaptive clinical trial platform designed to improve outcomes in high-risk breast cancer patients by testing new drugs in the neoadjuvant setting. The intent of this review is to discuss background, study structure, innovation, and outcomes of the I-SPY 2 trial.

Summary. I-SPY 2 (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2) is an ongoing, multi …

VerkkoInclusion Criteria for Treatment Phase of I-SPY 2 TRIAL . Eligible breast tumors must also meet one of the following criteria: Stage II or III; T4, any N, M0, including clinical or …

I-SPY 2 is designed for the rapid phase 2 assessment and personalized targeting of promising agents or combinations based on biomarker subtypes defined by hormone receptor, HER2, and MammaPrint (70-gene signature) status.

The I-SPY 2 trial is an adaptive clinical trial platform designed to improve outcomes in high-risk breast cancer patients by testing new ...

The I-SPY2 study is an ongoing, multicenter, open-label, adaptively randomized phase 2 multicenter trial of neoadjuvant chemotherapy (NACT) for ...

VerkkoI-SPY 2 TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging and Molecular AnaLysis 2, NCT01042379) has the framework of an adaptive …

I-SPY 2 is an ongoing, multicenter, open-label, adaptive phase 2 platform trial with multiple experimental groups to evaluate new agents combined with standard neoadjuvant therapy (Fig. 1). Open in a separate window

Jul 20, 2023 · We designed I-SPY 2, a phase 2, multicenter, adaptively randomized trial to screen multiple experimental regimens in combination with standard neoadjuvant chemotherapy for breast cancer. The goal...

VerkkoAmendment 11 Version date: 7/28/2014 Page i I-SPY 2 TRIAL (Investigation of Serial Studies to P redict Your Therapeutic Response with Imaging And moLecular Analysis 2) . UCSF …

I-SPY 2 (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2) is an ongoing, ...

The I-SPY series of trials are changing the way new treatments are developed for breast cancer, helping make available new, better and more personalized …