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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 ...

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

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 ...

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.

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.

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

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.

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

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 …

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

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 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.

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 …

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...

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.

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

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

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 …

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 …

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

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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 …

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.

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

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 …