Protocol Summary

Protocol No.

137669 (I SPY 2 097517)

Principal Investigator

Vaklavas, Christos



Age Group



NCT01042379 (Click to jump to

Eligibility Detail


I SPY 2 Trial: Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2


<strong>Primary Objective</strong>

<li>To determine whether adding investigational agents to standard neoadjuvant paclitaxel (with or without trastuzumab), and/or doxorubicin and cyclophosphamide, increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy alone, for each biomarker signature established at trial entry, and to determine for each experimental agent used, the predictive probability of success in a subsequent phase 3 trial for each possible biomarker signature.</li>

<strong>Secondary Objectives</strong>

<strong>Predictive and Prognostic Indices</strong>

<li>To build predictive and prognostic indices based on qualification and exploratory markers to predict pCR and residual cancer burden (RCB).</li>

<strong>Biological Specimen Resource and Imaging Data Base</strong>

<li>To initiate the creation of a Biological Specimen Repository, consisting of tumor tissue, RNA, DNA, serum, and cells, as well as corresponding magnetic resonance (MR) and pathology images of these specimens for ongoing translational studies in genomics, proteomics, and imaging in order to establish their relationship to overall survival (OS).</li>

<strong>Minimal Residual Disease</strong>

<li>To investigate the biology and clinical significance of minimal residual disease in blood and/or bone marrow of patients treated on the I-SPY 2 trial.</li>

<strong>Relapse-free Survival</strong>

<li>To determine three- and five-year relapse-free survival (RFS) and OS among the treatment arms.</li>

<strong>Investigational Agent Safety</strong>

<li>To determine incidence of adverse events (Aes), serious adverse events (SAEs), and laboratory abnormalities of each investigational agent tested.</li>

Applicable Disease Sites


Participating Institutions

Huntsman Cancer Institute : Kathryn Andrus



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