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I-SPY 2 TRIAL: (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2).

Primary Objective:
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.

Secondary Objectives:
1. Predictive and Prognostic Indices: To build predictive and prognostic indices based on qualification and exploratory markers to predict pCR and residual cancer burden (RCB).

2. Biological Specimen Resource and Imaging Data Base: 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).

3. Minimal Residual Disease: 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.

4. Relapse-free Survival: To determine three- and five-year relapse-free survival (RFS) and OS among the treatment arms.

5. Investigational Agent Safety: To determine incidence of adverse events (Aes), serious adverse events (SAEs), and laboratory abnormalities of each investigational agent tested.

Protocol Number: 042102
Phase: Phase I/II
Applicable Disease Sites: Breast
Drugs Involved: REGN3767
Cemiplimab (REGN2810)
Principal Investigator: Coral Omene MD, PhD
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Chemotherapy multiple agents systemic
Participating Institutions:
  • Rutgers Cancer Institute of New Jersey
  • RWJBarnabas Health
    • Cooperman Barnabas, Livingston
    • Robert Wood Johnson University Hospital, Somerset
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.