I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
18 Years and older, Male and Female
Summary
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.
Objectives
I-SPY2 will assess the efficacy of novel drugs in sequence with standard chemotherapy. The
goal is identify treatment strategies for subsets on the basis of molecular characteristics
(biomarker signatures) of their disease with high estimated pCR rate. As described for
previous adaptive trials, novel regimens with sufficiently high activities alone and
contribute to treatment strategies that show a high Bayesian predictive probability of being
more effective than the dynamic control will graduate from the trial with their corresponding
biomarker signature(s). Treatment strategies 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.
Eligibility
- Histologically confirmed invasive cancer of the breast
- Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)
- 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
- Age =18 years
- ECOG performance status 0-1
- Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers
- Non-pregnant and non-lactating
- No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.
- Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent)
- 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
- 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
- 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
- No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by = 50%
- 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
- 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™)
- Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2)
Treatment Sites in Georgia
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