Study Title

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

Summary

This research study is a phase 2 study. A phase 2 study tests if an investigational drug, or combination of investigational drugs, works in a certain type of cancer and what side effects it has. This study is also being done to determine whether MRI scans can be routinely used in women receiving neoadjuvant chemotherapy to predict (early in the course of treatment) which treatments will be most effective for women with breast cancer.

Objective

Primary Objective: To determine whether adding experimental agents to standard neoadjuvant paclitaxel (with or without trastuzumab), doxorubicin, and cyclophosphamide increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy 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: 1.2.1 Predictive and Prognostic Indices - To build predictive and prognostic indices based on qualification and exploratory markers to predict pCR and residual cancer burden (RCB). 1.2.2 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). 1.2.3 Relapse-free Survival - To determine three- and five-year relapse-free survival (RFS) and OS among the treatment arms. 1.2.4 Investigational Agent Safety - To determine incidence of adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities of each investigational agent tested.