5011W-10: I-SPY 2

CRC 10016: I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2)

Type of Study
Cancer (Oncology) - Breast
Swedish Cancer Institute
Short Description

Purpose: To further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.

Read and print the I-SPY 2 patient brochure
Visit the official I-SPY 2 website

Open to Enrollment
Principal Investigator
Erin Ellis, M.D. and Henry Kaplan, M.D.
Eligibility Notes
  • Histologically confirmed invasive cancer of the breast
  • Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis
  • No prior cytotoxic regimens are allowed for this malignancy.  Patient may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy.  Prior bisphosphonate therapy is allowed
  • Must be willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers
  • Any tumor ER/PgR status, any HER-2/neu status as measure by local hospital pathology laboratory
  • Tumor assay profile must include one of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (<5%), any HER2 status, or MammaPrint Low, ER positive, HER2/neu positive any any one of the three methods used (IHC, FISH, TargetPrint)
  • No use of any other investigational agents within 30 days of starting study treatment 
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
(206) 215-3086