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I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Cancer Type
Breast Cancer
Trial Phase
Phase II
18 Years and older, Male and Female
Study Type
Protocol IDs
097517 (primary)
Study Sponsor
QuantumLeap Healthcare Collaborative


The purpose of this study is 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.


I-SPY will compare the efficacy of novel drugs in combination with standard chemotherapy with
the efficacy of standard therapy alone. The goal is identify improved treatment regimens for
subsets on the basis of molecular characteristics (biomarker signatures) of their disease. As
described for previous adaptive trials, regimens that show a high Bayesian predictive
probability of being more effective than standard therapy will graduate from the trial with
their corresponding biomarker signature(s). Regimens will be dropped if they show a low
probability of improved efficacy with any biomarker signature. New drugs will enter as those
that have undergone testing complete their evaluation.


  1. Histologically confirmed invasive cancer of the breast
  2. Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)
  3. No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed
  4. Age =18 years
  5. ECOG performance status 0-1
  6. Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers
  7. Non-pregnant and non-lactating
  8. No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.
  9. Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent)
  10. 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
  11. Any tumor ER/PgR status, any HER-2/neu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section 4.1.2F
  12. Normal organ and marrow function: Leukocytes = 3000/µL, Absolute neutrophil count = 1500/µL, Platelets = 100,000/µL, Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be = 2.0 x ULN, AST(SGOT)/ALT (SGPT) = 1.5 x institutional ULN, creatinine < 1.5 x institutional ULN
  13. No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by = 50%
  14. No clinical or imaging evidence of distant metastases by PA and Lateral CXR, Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline phosphatase
  15. Tumor assay profile must include on 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 by any one of the three methods used (IHC, FISH, TargetPrint™)
  16. Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2)

Treatment Sites in Georgia

Emory University Hospital - Atlanta

1364 Clifton Road NE
Atlanta, GA 30322

Winship Cancer Institute of Emory University

1365 Clifton Road NE
Building C
Atlanta, GA 30322

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE


Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.